Podcasts about prescribing information

Dr. Chapa’s Clinical Pearls.

Play Episode Listen Later Feb 18, 2025 22:00

The journey from the first sign of plaque psoriasis to diagnosis and beyond is very familiar to Brandon, Christy and Daryl. Hear these real patients share the good and the bad of their plaque psoriasis journeys with moderator Max Blitstein. Listen as they discuss how they became empowered self advocates by speaking up for themselves with their healthcare provider. What differences did it make for them? Tune in to find out. This episode is sponsored by Arcutis Biotherapeutics, Inc. Please see Important Safety Information and full Prescribing Information for the product mentioned in this podcast.

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FDA Warning: RSV Vacc and GBS (Breaking it Down)

Play Episode Listen Later Jan 10, 2025 34:00

Guillain-Barré syndrome (GBS) is a rare disorder that causes muscle weakness and sometimes paralysis. It's caused by the body's immune system damaging nerves. While most cases are triggered by respiratory or gastrointestinal infections, vaccinations have also been linked to GBS pathogenesis. GBS can last from weeks to years, but most people start to recover within a few weeks. The earlier symptoms improve, the better the outlook. Physical therapy is important to prevent muscle contractures and deformities. Some people may experience long-term weakness, numbness, fatigue, or pain. A small percentage of people with GBS may have a relapse, which can cause muscle weakness years after symptoms end. On Jan 7, 2025, the FDA required and approved UPDATED safety labeling changes to the Prescribing Information for Abrysvo (Respiratory Syncytial Virus Vaccine) manufactured by Pfizer Inc. and Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) manufactured by GlaxoSmithKline Biologicals. Specifically, FDA has required each manufacturer to include a new warning about the risk for Guillain-Barré syndrome (GBS) following administration of their Respiratory Syncytial Virus (RSV) vaccine. Who is most at risk for GBS? Where pregnant women affected? This is important information….listen in for details.

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An additional treatment option with TAGRISSO® (osimertinib) (Sponsored)

The Top Line

Play Episode Listen Later Jan 10, 2025 14:25

Arun Krishna, Vice President and franchise head for an AstraZeneca US OBU, shares details of a treatment option with TAGRISSO® (osimertinib). AstraZeneca is focused on the development of new treatments, prioritizing researching options in eligible patients. Listen to the full podcast episode to learn more. Please see Important Safety Information for TAGRISSO. Please see complete Prescribing Information, including Patient Information for TAGRISSO.See omnystudio.com/listener for privacy information.

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#53 Closing the Confidence Gap | Shawna Chrisman & Keta Burke-Williams

Derm Club with Dr. Hannah Kopelman

Play Episode Listen Later Nov 19, 2024 34:46

In this episode of the Derm Club Podcast, I am joined by two inspirational entrepreneurs: Shawna Chrisman, a Nurse Practitioner and the founder of Destination Aesthetics Medical Spa, and Keta Burke-Williams, the founder and CEO of Ourside, a luxury fragrance brand. Shawna shares her journey from starting her business in a single room to scaling up to five thriving locations. She discusses her role as a coach in the BOTOX® Cosmetic (onabotulinumtoxinA) Grant Program Bootcamp and her passion for aesthetics. Keta, a recipient of the 2024 BOTOX® Cosmetic Grant, talks about redefining luxury fragrances and the impact of the grant on her business, including the opportunities it has provided for mentorship and community building. Listeners will be inspired by the candid stories of these two remarkable women as they discuss the challenges and triumphs of their entrepreneurial journeys. The conversation delves into the importance of authenticity, community support, and the power of mentorship in achieving success. This episode is part of a series sponsored by BOTOX® Cosmetic. BOTOX® Cosmetic (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet, frown lines, and vertical bands connecting the neck and jaw in adults (platysma bands). Talk to your doctor about BOTOX® Cosmetic and whether it's right for you. There are risks with this product—the effects of BOTOX® Cosmetic may spread hours to weeks after injection causing serious symptoms. Alert your doctor right away as difficulty swallowing, speaking, breathing, eye problems or muscle weakness can be a sign of a life-threatening condition. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Patients with these conditions before injection are at the highest risk. Swallowing problems may last for several months. Side effects may include allergic reactions, neck and injection-site pain, fatigue and headache. Don't receive BOTOX® Cosmetic if there's a skin infection. Tell your doctor your medical history, muscle or nerve conditions, and medications, including botulinum toxins, as these may increase the risk of serious side effects. For full Prescribing Information, including Boxed Warning, visit BotoxCosmetic.com or call 877.351.0300. For Boxed Warning and full Prescribing Information, see https://lnkd.in/gFi3bXxE Connect with me across Social: X: https://x.com/drhankopelman Instagram: https://www.instagram.com/drhannahkopelman/ TikTok: https://www.tiktok.com/@drhankopelman Online Dermatology Care: https://dermondemand.com The content of this podcast is for entertainment and educational purposes only. This content is not meant to be a substitute for medical advice or treatment for any medical condition.

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How do you say umeclidinium? (Pronunciation Series Episode 40)

Pharmacist's Voice

Play Episode Listen Later Oct 4, 2024 6:09

Welcome to the 40th episode in my drug pronunciation series. In this episode, I break down umeclidinium and Incruse Ellipta into syllables, tell you which syllables to emphasize, and share my sources. The written pronunciations are helpful. They are below and in the show notes for episode 298 on thepharmacistsvoice.com. Umeclidinium = ue-ME-kli-DIN-ee-um Emphasize ME and DIN (emphasize DIN the most) Sources: USP Dictionary Online and Medline Plus Incruse Ellipta = IN-cruise e-LIP-ta Emphasize IN and LIP Sources: Prescribing Information for Incruse Ellipta (GSK's website) or FDA's website Thank you for listening to episode 298 of The Pharmacist's Voice ® Podcast. To read the FULL show notes (including all links), visit https://www.thepharmacistsvoice.com/podcast. Select episode 298. If you know someone who needs to learn how to say umeclidinium and Incruse Ellipta, please share this episode with them. Subscribe for all future episodes. This podcast is on all major podcast players and YouTube. Links to popular podcast players are below. ⬇️ Apple Podcasts https://apple.co/42yqXOG Spotify https://spoti.fi/3qAk3uY Amazon/Audible https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt Links from this episode USP Dictionary Online (Subscription-based resource) USP Dictionary's pronunciation guide (Free resource on The American Medical Association's website) Medline Plus https://medlineplus.gov/druginfo/meds/a614024.html Prescribing Information for Incruse Ellipta from GSK's website. See also FDA's website. The Pharmacist's Voice Podcast Episode 296, Pronunciation Series Episode 39 (Januvia) The Pharmacist's Voice Podcast Episode 294, Pronunciation Series Episode 38 (Yasmin) The Pharmacist's Voice Podcast Episode 292, Pronunciation Series Episode 37 (Xanax, alprazolam) The Pharmacist's Voice Podcast Episode 290, Pronunciation Series Episode 36 (quetiapine) The Pharmacist's Voice Podcast Episode 287, pronunciation series ep 35 (bupropion) The Pharmacist's Voice Podcast Episode 285, pronunciation series ep 34 (fentanyl) The Pharmacist's Voice Podcast Ep 281, Pronunciation Series Ep 33 levothyroxine (Synthroid) The Pharmacist's Voice ® Podcast Ep 278, Pronunciation Series Ep 32 ondansetron (Zofran) The Pharmacist's Voice ® Podcast Episode 276, pronunciation series episode 31 (tocilizumab-aazg) The Pharmacist's Voice ® Podcast Episode 274, pronunciation series episode 30 (citalopram and escitalopram) The Pharmacist's Voice ® Podcast Episode 272, pronunciation series episode 29 (losartan) The Pharmacist's Voice Podcast Episode 269, pronunciation series episode 28 (tirzepatide) The Pharmacist's Voice Podcast Episode 267, pronunciation series episode 27 (atorvastatin) The Pharmacist's Voice Podcast Episode 265, pronunciation series episode 26 (omeprazole) The Pharmacist's Voice Podcast Episode 263, pronunciation series episode 25 (PDE-5 inhibitors) The Pharmacist's Voice Podcast Episode 259, pronunciation series episode 24 (ketorolac) The Pharmacist's Voice ® Podcast episode 254, pronunciation series episode 23 (Paxlovid) The Pharmacist's Voice ® Podcast episode 250, pronunciation series episode 22 (metformin/Glucophage) The Pharmacist's Voice Podcast ® episode 245, pronunciation series episode 21 (naltrexone/Vivitrol) The Pharmacist's Voice ® Podcast episode 240, pronunciation series episode 20 (levalbuterol) The Pharmacist's Voice ® Podcast episode 236, pronunciation series episode 19 (phentermine) The Pharmacist's Voice ® Podcast episode 228, pronunciation series episode 18 (ezetimibe) The Pharmacist's Voice ® Podcast episode 219, pronunciation series episode 17 (semaglutide) The Pharmacist's Voice ® Podcast episode 215, pronunciation series episode 16 (mifepristone and misoprostol) The Pharmacist's Voice ® Podcast episode 211, pronunciation series episode 15 (Humira®) The Pharmacist's Voice ® Podcast episode 202, pronunciation series episode 14 (SMZ-TMP) The Pharmacist's Voice ® Podcast episode 198, pronunciation series episode 13 (carisoprodol) The Pharmacist's Voice ® Podcast episode 194, pronunciation series episode 12 (tianeptine) The Pharmacist's Voice ® Podcast episode 188, pronunciation series episode 11 (insulin icodec) The Pharmacist's Voice ® Podcast episode 184, pronunciation series episode 10 (phenytoin and isotretinoin) The Pharmacist's Voice ® Podcast episode 180, pronunciation series episode 9 Apretude® (cabotegravir) The Pharmacist's Voice ® Podcast episode 177, pronunciation series episode 8 (metoprolol) The Pharmacist's Voice ® Podcast episode 164, pronunciation series episode 7 (levetiracetam) The Pharmacist's Voice ® Podcast episode 159, pronunciation series episode 6 (talimogene laherparepvec or T-VEC) The Pharmacist's Voice ® Podcast episode 155, pronunciation series episode 5 Trulicity® (dulaglutide) The Pharmacist's Voice ® Podcast episode 148, pronunciation series episode 4 Besponsa® (inotuzumab ozogamicin) The Pharmacist's Voice ® Podcast episode 142, pronunciation series episode 3 Zolmitriptan and Zokinvy The Pharmacist's Voice ® Podcast episode 138, pronunciation series episode 2 Molnupiravir and Taltz The Pharmacist's Voice ® Podcast episode 134, pronunciation series episode 1 Eszopiclone and Qulipta Kim's websites and social media links: ✅Business website https://www.thepharmacistsvoice.com ✅The Pharmacist's Voice ® Podcast https://www.thepharmacistsvoice.com/podcast ✅Pronounce Drug Names Like a Pro © Online Course https://www.kimnewlove.com ✅A Behind-the-scenes look at The Pharmacist's Voice ® Podcast © Online Course https://www.kimnewlove.com ✅LinkedIn https://www.linkedin.com/in/kimnewlove ✅Facebook https://www.facebook.com/kim.newlove.96 ✅Twitter https://twitter.com/KimNewloveVO ✅Instagram https://www.instagram.com/kimnewlovevo/ ✅YouTube https://www.youtube.com/channel/UCA3UyhNBi9CCqIMP8t1wRZQ ✅ACX (Audiobook Narrator Profile) https://www.acx.com/narrator?p=A10FSORRTANJ4Z ✅Start a podcast with the same coach who helped me get started (Dave Jackson from The School of Podcasting)! **Affiliate Link - NEW 9-8-23** Thank you for listening to episode 298 of The Pharmacist's Voice ® Podcast. If you know someone who would like this episode, please share it with them!

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Ep. 235 "Is It Plaque Psoriasis? Recognizing and Managing the Disease in Skin of Color" a Johnson & Johnson-sponsored episode

Play Episode Listen Later Oct 1, 2024 30:03

Patient advocate Alisha Bridges and dermatologist Dr. Mona Shahriari discuss a study dedicated to people of all skin tones who have moderate to severe plaque psoriasis. Dr. Shahriari also shares her experience guiding people with skin of color as they navigate their psoriasis journey. This episode is sponsored by Johnson & Johnson. Please see Important Safety Information and full Prescribing Information for the product mentioned in the podcast.

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Apalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC): A Case-Based Discussion

AUA Inside Tract

Play Episode Listen Later May 31, 2024 35:38

This podcast “Apalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC): A Case-Based Discussion” was originally presented as an AUA newsworthy webinar and contains data regarding the clinical efficacy and safety of apalutamide. It is presented on behalf of Janssen and is not certified for CME; speakers were compensated. For full details, see the video webinar here. TITAN, a Phase 3 double-blind study, randomized patients with metastatic castration-sensitive prostate cancer (mCSPC) to apalutamide (Apa; 240 mg oral once daily) + androgen deprivation therapy (ADT; n=525) or placebo + ADT (n=527).1,2 All patients received a concomitant gonadotropin-releasing hormone analog or had prior bilateral orchiectomy.3 Patients who received prior treatment for localized disease or received but did not progress on docetaxel were permitted. Dual primary endpoints were radiographic progression-free survival and overall survival (OS).1,2 At primary analysis (median follow-up: 22.7 months), Apa + ADT reduced the risk of radiographic progression or death by 52% vs placebo + ADT (HR: 0.48; 95% CI: 0.39–0.60). Apa + ADT also reduced the risk of death by 33% vs placebo + ADT (HR: 0.67; 95% CI: 0.51–0.89).1 At primary analysis cutoff, TITAN was unblinded and 39.5% of patients who received placebo + ADT crossed over to receive Apa + ADT; these patients were analyzed as part of the placebo + ADT population in the intent-to-treat analyses. The IPCW log-rank test was performed to account for crossover and showed a 48% reduction in the risk of death for Apa + ADT vs placebo + ADT (HR: 0.52; 95% CI: 0.42–0.64). At final analysis (median follow-up: 44.0 months), Apa + ADT reduced the risk of death by 35% vs placebo + ADT (median OS: NE vs 52.2 months; HR: 0.65; 95% CI: 0.53–0.79). In a prespecified subgroup analysis, Apa + ADT improved OS vs placebo + ADT, regardless of disease volume. In patients with high-volume disease, Apa + ADT reduced the risk of death by 30% vs placebo + ADT (HR: 0.70; 95% CI: 0.56–0.88); for low-volume disease, Apa + ADT reduced the risk of death by 48% vs placebo + ADT (HR: 0.52; 95% CI: 0.35–0.79).2 The following post hoc analyses data are not included in the full ERLEADA® (apalutamide) Prescribing Information. Post hoc exploratory analyses investigated PSA kinetics.4,5 After 3 months of Apa treatment, median OS was not reached in patients with a PSA response. In patients without a PSA response, median OS was 37.7 months.5 Most Apa + ADT-treated patients had undetectable PSA at 3 months. By 12 months, 64% of Apa-treated patients had undetectable PSA vs 23% of patients treated with placebo + ADT.5 Please see the full Prescribing Information for ERLEADA® (apalutamide) at www.erleadahcp.com. Chi KN, et al. N Engl J Med. 2019;381:13–24. Chi KN, et al. J Clin Oncol. 2021;39:2294–2303. ERLEADA® (apalutamide) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. Chowdhury S, et al. Ann Oncol. 2023;34:477–485. Chi KN, et al. Presented at AUA; September 10–13, 2021; Las Vegas, Nevada.

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Objective Measures and Endoscopic Improvement

Gut Reactions Podcast

Play Episode Listen Later Feb 14, 2024 30:37

Dr. Rubin welcomes guest Dr. Oriana Damas, IBD Physician Scientist and Director of Translational Studies at the University of Miami Crohn's and Colitis Center, to discuss the importance of objective measures in UC, such as endoscopic improvement and histo-endoscopic mucosal improvement, and their place in your clinical practice. Click here for Prescribing Information, including BOXED WARNING, of the treatment option mentioned within this podcast.

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The Switch Ready Patient

Gut Reactions Podcast

Play Episode Listen Later Feb 14, 2024 41:04

Dr. Rubin and guest Dr. Josh Steinberg, a board-certified gastroenterologist and director of IBD at Gastroenterology of the Rockies, discuss treatment goals and setting expectations for UC patients, evaluating loss of response, and interpreting objective measures of patients who may need a treatment change. The two also share their personal experiences with transitioning patients to an appropriate therapy. Click here for Prescribing Information, including BOXED WARNING, of the treatment option mentioned within this podcast.

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Ep. 217 "Simplifying Psoriasis Management with Steroid-Free Therapy" An Arcutis sponsored episode.

Advances in Women's Health

Play Episode Listen Later Jan 30, 2024 28:09

Jillian who is living with plaque psoriasis, and board-certified nurse practitioner, Melodie Young, discuss disease management with topicals. This episode is sponsored by Arcutis Biotherapeutics, Inc. Please see Important Safety Information and full Prescribing Information including Patient Information for Zoryve (roflumilast) indicated for use on the skin (topical), including in areas with skin folds, to treat plaque psoriasis in people six years of age and older.

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Heart Disease: A Mother-Daughter Bond and Life With Obstructive HCM

The Mighty Podcast

Play Episode Listen Later Jan 29, 2024 39:30

What does caregiving look like when you're living nearly 9,000 miles apart? In this episode of The Mighty Podcast, a mother — who lives with symptomatic obstructive hypertrophic cardiomyopathy (HCM) — and her daughter discuss her mom's life from symptom onset to finding a treatment that is working for her. They also talk about the duality in the daughter's role as both daughter and caregiver as she supports her mom through her best and worst days with the disease (and everything in between!). Come for their relatable story, and stay for the genuine mother-daughter bond you can feel through the microphones. Listen in: https://bit.ly/49dqxRg #Sponsored by Bristol Myers Squibb The patient and caregiver are paid spokespeople on behalf of BMS. Click here for U.S. Prescribing Information, including Boxed WARNING: https://bit.ly/3OlFtVQ Click here for Medication Guide: https://bit.ly/3UixuN1

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A Treatment Option for Heavy Menstrual Bleeding Due to Uterine Fibroids or Moderate to Severe Pain Due to Endometriosis in Premenopausal Women

Play Episode Listen Later Dec 6, 2023

Host: Jennifer Caudle, DO Guest: Rosanne Kho, MD To learn how Myfembree® (relugolix, estradiol, norethindrone acetate) could help address uterine fibroid-associated heavy menstrual bleeding or moderate to severe endometriosis pain in premenopausal women; listen to Dr. Jennifer Caudle and Dr. Rosanne Kho, Chair of the OB/GYN Department at the University of Arizona College of Medicine in Phoenix. Please scroll for Important Safety Information. Please see full Prescribing Information including BOXED WARNING here.

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A Treatment Option for Heavy Menstrual Bleeding Due to Uterine Fibroids or Moderate to Severe Pain Due to Endometriosis in Premenopausal Women

Play Episode Listen Later Dec 6, 2023

Host: Jennifer Caudle, DO Guest: Rosanne Kho, MD To learn how Myfembree® (relugolix, estradiol, norethindrone acetate) could help address uterine fibroid-associated heavy menstrual bleeding or moderate to severe endometriosis pain in premenopausal women; listen to Dr. Jennifer Caudle and Dr. Rosanne Kho, Chair of the OB/GYN Department at the University of Arizona College of Medicine in Phoenix. Please scroll for Important Safety Information. Please see full Prescribing Information including BOXED WARNING here.

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Episode 142: Tirzepatide II

Rio Bravo qWeek

Play Episode Listen Later Jun 23, 2023 18:06

Episode 142: Tirzepatide IIFuture Dr. Beuca explains that tirzepatide has shown benefits in patients with obesity that go beyond its weight-reducing effects and includes reduction of blood pressure, among others. Dr. Arreaza explains that Wegovy (semaglutide approved for weight loss) is also very beneficial for weight loss and explains. Written by Maria Beuca, MSIV, Ross University School of Medicine. Comments by Hector Arreaza, MD.You are listening to Rio Bravo qWeek Podcast, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California, a UCLA-affiliated program sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home. This podcast was created for educational purposes only. Visit your primary care provider for additional medical advice.Maria: Hello everyone, today is June 2, 2023, and we want to re-visit our discussion about the drug Tirzepatide from our May 19th, 2022. A little re-cap for those of you who don't know, tirzepatide, also known by the brand name Mounjaro, is a drug that was approved by the FDA a year ago for the treatment of type 2 Diabetes. It is similar to the drug Semaglutide, also known by the brand name Ozempic which many of you may be more familiar with, thanks to the Kardashians and other celebrities making it popular as a “weight loss” drug. Arreaza: The brand name for weight semaglutide is Wegovy.Maria: Both of these drugs are injected once a week and mimic the effect of the incretin hormone GLP-1 by binding to its receptor. Incretin hormones are a group of hormones that cause insulin to be released from the pancreas after eating to help lower blood sugar levels. These incretin hormones also help suppress the appetite, causing you to eat less and lose weight. Tirzepatide is different because it is the first drug to mimic the action of two hormones, both GLP-1 and GIP. In our last episode, we also discussed the SURPASS-2 study that showed tirzepatide to be superior to semaglutide because of this dual incretin action, with greater weight loss, lower HA1c levels, and lower triglyceride and VLDL levels. At that time, we also mentioned the SURMOUNT-1 Phase 3 clinical trial that was ongoing at the time. Well, it is now complete, and the results are in. There were 2,539 obese or overweight participants without diabetes in the study who lost between 16-22.5% of their starting weight on Tirzepatide. On 15 mg dose, participants lost about 52 lbs (24 kg), on 10 mg 49 lbs (22 kg) and on 5 mg about 35 lbs (16 kg), but those on the placebo lost only 2.4% or about 5 lbs (2 kg). As you can see there is very little difference in weight loss between the 10 mg dose and the 15 mg dose, although a big difference is seen compared to the 5 mg dose. It's important to note that they took Tirzepatide for 72 weeks or a year and a half. Arreaza: That's very significant weight loss. It is important to emphasize that these patients did NOT have diabetes. Maria: These weight loss results have proven to be comparable to bariatric surgery. The study also showed improvement in cardiovascular and metabolic risk factors such as lower blood pressure, fasting insulin, lipid levels and even aspartate aminotransferase levels in comparison to the placebo. By the end of the study, more than 95% of the participants who had pre-diabetes had converted to normal glucose levels. This study was so impressive that it was presented at the 82nd Scientific Sessions of the American Diabetes Association and was also published in The New England Journal of Medicine. Arreaza: It seems like tirzepatide is ahead of the game for weight loss.Maria: Although it is approved as a drug for diabetes, the next step is to approve it for weight loss and to begin treating obesity as a chronic disease that needs to be treated. Maria: And this makes sense. Currently, more than 4 in 10 American adults have obesity, and obesity is the cause of many other conditions. Just yesterday, I was seeing patients in the orthopedic clinic and I had several patients being seen for knee pain due to obesity, and they are postponing surgery because they have been losing weight on tirzepatide and are already feeling better. I think avoiding knee surgery alone is a pretty good reason to approve these drugs for weight loss, but there are many other conditions that are improved by weight loss. Arreaza: My anecdotes are related to semaglutide, but I can imagine that this may also apply to tirzepatide. I had a patient who was able to stop all antihypertensive medications because of 40-lb weight loss. Maria: Dr. Caroline Apovian, director of the Center for Weight Management and Wellness at Brigham Women's Hospital, states that “If everybody who had obesity in this country lost 20% of their body weight, we would be taking patients off all these medications for reflux, for diabetes, for hypertension. We would not be sending patients for stent replacement.”Maria: Last month, officials from Eli Lilly, the company that makes tirzepatide, stated that they are hoping to have a fast-track approval to sell it for chronic weight management by sometime this year. The problem is that many of these patients who were prescribed Tirzepatide have not been able to get it because it has been out of stock for the last few months in all the local pharmacies. They get the prescription, start taking Tirzepatide and begin to lose weight or improve their blood sugar levels and then it is out of stock and now you have people with Diabetes who have gotten off insulin because Tirzepatide worked so well and suddenly they can't get it and are at risk for getting pretty sick without it. Arreaza: The manufacturer of Wegovy announced this, “we will only be able to supply limited quantities of 0.25 mg, 0.5 mg, and 1 mg dose strengths to wholesalers for distribution to retail pharmacies which will not meet anticipated patient demand. We anticipate that many patients will have difficulty filling Wegovy® prescriptions at these doses through September 2023. We do not currently anticipate supply interruptions of the 1.7 mg and 2.4 mg dose strengths of Wegovy®”. Why is this happening? Maria: The problem is that this drug was not meant for the masses, for all these young girls wanting to lose a few pounds for aesthetic reasons. It was meant for people with a BMI 30 or with a BMI 27 plus another comorbidity such as hypertension. Celebrities have brought attention to these drugs for weight loss, for example Ozempic has over 433 million views on TikTok. It has gotten so bad that people are turning to questionable sources online to purchase these drugs, where it is given cute names like “skinny shots.” And if your insurance does not cover Tirzepatide, it is still expensive, starting at around $1000 per month. Some of the insurers who used to cover the cost stopped covering it or placed new restrictions on who qualifies. Another downside is that tirzepatide and other drugs of this class have not been on the market that long, so the long-term effects are still not known. So far, early evidence shows that most people gain the weight back as soon as they stop taking it, so are the weight loss benefits sustainable at this high cost? Maria: We talked about the adverse effects in the last episode, but it's important to go over them again. Patients can have diarrhea, nausea, vomiting, constipation, and abdominal pain that can often bring these patients into the clinic or even the Emergency room thinking they are ill, when in fact it is an adverse effect of their medication, especially the first few days of starting or increasing the dose. So, educating patients is very important before they start this new drug. There is also a small risk of pancreatitis or gallbladder problems, so it is important to have blood work done to check the pancreas and gallbladder prior to starting tirzepatide. There is also a warning to avoid using it if you have a family or personal history of thyroid cancer. Arreaza: Reminder, MEN type 1. I would like to mention the so-called “Ozempic face”. It is the face you get with rapid weight loss, making you look a little older due to fat loss on the face. As a summary, tirzepatide is a very effective medication for weight loss, pending FDA approval. It is not free of side effects, so we still need to follow the recommendations from FDA and other reputable sources to prescribe it responsibly. There is room for further research on these medications. Currently, there are no clear guidelines regarding labs before starting treatment (lipase?) or labs for monitoring after treatment. The evidence regarding these medications continues to evolve and we should stay up to date with the changes. _______________________Conclusion: Now we conclude episode number 142 “Tirzepatide II.” Future Dr. Beuca came back almost one year later to shed more light on the use of tirzepatide in the treatment of obesity. Dr. Arreaza provided some insight into the management of side effects and the potential harm of this novel medication. Overall, tirzepatide is effective and safe and may be the answer to many of our patients with diabetes and obesity. This week we thank Hector Arreaza and Maria Beuca. Audio editing by Adrianne Silva.Even without trying, every night you go to bed a little wiser. Thanks for listening to Rio Bravo qWeek Podcast. We want to hear from you, send us an email at RioBravoqWeek@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. See you next week! _____________________References:Brownie, Grace. “The Problematic Arrival of Anti-Obesity Drugs.” Wired, 25 January 2023. https://www.wired.com/story/anti-obesity-drugs/Dockrill, Peter. “Experimental Drug Breaks Record for Weight Loss in Latest Clinical Trial Results.”ScienceAlert, 9 May 2022, https://www.sciencealert.com/experimental-drug-breaks-record-for-weight-loss-in-latest-clinical-trial-results.Frías, Juan P., et al. “Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.”New England Journal of Medicine, 5 August 2021, https://www.nejm.org/doi/full/10.1056/NEJMoa2107519.Jastreboff, Ania M., et al. “Tirzepatide Once Weekly for the Treatment of Obesity.” New England Journal of Medicine, 21 July 2022, www.nejm.org/doi/full/10.1056/NEJMoa2206038.“Label as Approved by FDA. - Pi.lilly.com.”Mounjaro Prescribing Information, Lilly USA, LLC, May 2022, https://pi.lilly.com/us/mounjaro-uspi.pdf.Mounjaro. Prescribing Information. Lilly USA, LLC. May 2022. https://pi.lilly.com/us/mounjaro-uspi.pdf?s=pi“Surmount-1 Study Finds Individuals with Obesity Lost up to 22.5% of their Body Weight when Taking Tirzepatide.” 4 June 2022. https://diabetes.org/newsroom/press-releases/2022/surmount-1-study-finds-individuals-%20with-obesity-lost-up-to-22.5-percent-body-weight-taking-tirzepatide.Royalty-free music used for this episode: "Happy-Go-Lucky." Downloaded on October 13, 2022, from https://www.videvo.net/

FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use

FDA Drug Safety Podcasts

Play Episode Listen Later May 10, 2023 7:30

Listen to an audio podcast of the April 13, 2023, FDA Drug Safety Communication, FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use.

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MPR Weekly Dose 155 — Knee Shock Absorber; Opioid Label Updates; Imbruvica Indications Withdrawn; Patch for Excessive Sweating; Polyclonal Tx for Flu

MPR Weekly Dose

Play Episode Listen Later Apr 14, 2023 13:00

Implantable device approved for those with knee osteoarthritis; Prescribing Information labeling updated for opioids; Imbruvica indications withdrawn; Patch to combat excessive underarm sweating given green light; Novel treatment Fast Tracked for Type A and B influenza.

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Hosted by Dr. Scott Sigman – “Dr. Will Kurtz”

Play Episode Listen Later Dec 7, 2022

This episode is brought to you by TrackableMed, the place to go to help grow your new patient base. This episode is also brought to you by Heron Therapeutics. Please see full Prescribing Information, including Boxed Warning or visit www.ZYNRELEF.com. Dr. William B. Kurtz is a board-certified, fellowship-trained orthopedic surgeon who specializes in hip and knee replacements at Tennessee Orthopaedic Alliance. Dr. Kurtz holds a bachelor's degree in mechanical engineering from Rice University. He graduated medical school from The University of Texas Southwestern Medical School at Dallas with Alpha Omega Alpha honors distinction. He completed a residency in orthopedic surgery at Vanderbilt University Medical Center, followed by a subspecialty fellowship in adult reconstructive joint surgery at New England Baptist Hospital in Boston. Topics include: -His role in Ortho Founders, a place where orthopreneurs can pitch their innovations and gain feedback from other leaders in orthopedics. -Dr. Will Kurtz is President of Tennessee Orthopaedic Alliance, a group of 106 physicians. He is also a board member in Ortho Forum, whose members comprise 100 private practice groups across the U.S. to share data analysis and best practices on revenue cycle management and ancillary revenue streams. -He's done over 10,000 Conformis knees, made specifically for the patient. Dr. Kurtz breaks down the difference between Conformis personalized knees and a standard total knee, which comes off-the-shelf. -We discuss his recent business case study in Journal Orthopaedic Experience and Innovation, Value Creation vs Value Capture in Orthopedics. Find out more about Dr. Will Kurtz here. Also, find out more about Zynrelef here: ZYNRELEF utilizes a novel synergistic mechanism of action that combines bupivacaine with a low dose of meloxicam to overcome the challenges of the inflammatory process at the surgical site. ZYNRELEF is the first and only extended-release dual-acting local anesthetic™ (DALA™) and delivers 72 hours of postoperative pain relief via a single needle-free application. It has been clinically proven to better manage pain than standard of care bupivacaine HCl solution over 72 hours and to significantly reduce opioid utilization following surgery. -ZYNRELEF was initially approved by the FDA in May 2021 and in December 2021, the FDA approved an expansion of ZYNRELEF's indication. -Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ZYNRELEF is contraindicated for: • Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF OR history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients • Patients undergoing obstetrical paracervical block...

Ep. #177 "What Does it Mean to Live Well With Plaque Psoriasis?" A Dermavant Sciences sponsored episode.

Play Episode Listen Later Oct 27, 2022 25:08

Psoriasis is a lifelong disease with no cure, but that doesn't mean you can't thrive in your everyday life. Listen as board-certified dermatologist Dr. Mona Shahriari, shares tips to overcome plaque psoriasis and maintain a high quality of life. This Psound Bytes™ episode is sponsored by Dermavant Sciences. For Important Safety and Prescribing Information visit VTAMA.com.

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Hosted by Dr. Scott Sigman – “Dr. Dror Paley”

Play Episode Listen Later Oct 18, 2022 33:30

This episode is brought to you by TrackableMed, the place to go to help grow your new patient base. This episode is brought to you by Heron Therapeutics. Please see full Prescribing Information, including Boxed Warning or visit www.ZYNRELEF.com. Dror Paley, MD, FRCSC, is the founder (2009) and director of the Paley Institute in West Palm Beach, Florida. Prior to that he was the founder (2001) and director of the Rubin Institute for Advanced Orthopedics, and the director of the International Center for Limb Lengthening (ICLL) at Sinai Hospital of Baltimore from 2001-2009. He was the Chief of Pediatric Orthopedics at the University of Maryland in Baltimore 1987-2001. He is internationally recognized for his expertise in limb lengthening and reconstruction. Topics include: -We hear why he went into orthopedics and then chose the niche path for limb lengthening. Dr. Paley trained under the guidance of Professor Ilizarov of Russia (Ilizarov method) and Professor Debastiani of Italy (Orthofix method). In 1986, he introduced the Ilizarov method to the United States and Canada. Since that time, he has performed more than 20,000 limb lengthening and reconstruction-related procedures. Patients come to his Institute from more than 100 countries. -Dr. Paley reviews how limb lengthening works and breaks down this complex topic for anyone to understand, including the different types of limb lengthening to include the use of external fixators, often called cages, and remote controlled internal limb lengthening. Find out more about Dr. Dror Paley here. Also, find out more about Zynrelef here: ZYNRELEF utilizes a novel synergistic mechanism of action that combines bupivacaine with a low dose of meloxicam to overcome the challenges of the inflammatory process at the surgical site. ZYNRELEF is the first and only extended-release dual-acting local anesthetic™ (DALA™) and delivers 72 hours of postoperative pain relief via a single needle-free application. It has been clinically proven to better manage pain than standard of care bupivacaine HCl solution over 72 hours and to significantly reduce opioid utilization following surgery. -ZYNRELEF was initially approved by the FDA in May 2021 and in December 2021, the FDA approved an expansion of ZYNRELEF's indication. -Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ZYNRELEF is contraindicated for: • Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF OR history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients • Patients undergoing obstetrical paracervical block anesthesia OR coronary artery bypass graft (CABG) surgery WARNINGS AND PRECAUTIONS include –

united states university canada chief institute maryland patients md baltimore fda limitations gi elderly severe west palm beach international center nsaids dala hcl paley dror sinai hospital sigman cabg frcsc nonsteroidal boxed warning prescribing information scott sigman

Hosted by Dr. Scott Sigman – “Dr. Brian Cole”

Play Episode Listen Later Aug 17, 2022 40:00

This episode is brought to you by Heron Therapeutics. Please see full Prescribing Information, including Boxed Warning or visit www.ZYNRELEF.com. This episode is also brought to you by TrackableMed, grow your new patients. We have the one and only Dr. Brian Cole for this episode. Dr. Brian Cole is an orthopedic sports medicine surgeon at Midwest Orthopaedics at Rush and a Professor of Orthopaedics, Anatomy and Cell Biology at Rush University Medical Center. Dr. Cole is Managing Partner of Midwest Orthopaedics and is the Department's Associate Chairman and the Section Head of the Cartilage Research and Restoration Center. He's one of the most prolific and most influential sports medicine surgeons in the world. Dr. Cole is the head team physician for the Chicago Bulls and co-team physician for the Chicago White Sox. He's a member of every society for sports medicine orthopedics with a vast history of experience with a passion for education. This is one you're going to enjoy! Topics include:-He discusses what made him decide to become a physician and the influence going into orthopedics, including residency at the Hospital for Special Surgery at Cornell Medical Center, and a Sports Medicine fellowship at the University of Pittsburgh. Dr. Cole talks about how he made his way back to Chicago after fellowship at Midwest Orthopaedics at Rush and helping to build the cartilage restoration program. -He talks about the "private-demic" model of Rush, running it as a private practice with the benefits of being in the academic world. It's a private independent practice that fosters entrepreneurialism. -Dr. Cole has a passion for fellowships and can hear his devotion for the importance of mentorships. He discusses how it's essential to positively influence the next generation through fellowships. -We also hear about what is his work//life balance like with all of his responsibilities. Find out more about Dr. Brian Cole here. Also, find out more about Zynrelef here: ZYNRELEF utilizes a novel synergistic mechanism of action that combines bupivacaine with a low dose of meloxicam to overcome the challenges of the inflammatory process at the surgical site. ZYNRELEF is the first and only extended-release dual-acting local anesthetic™ (DALA™) and delivers 72 hours of postoperative pain relief via a single needle-free application. It has been clinically proven to better manage pain than standard of care bupivacaine HCl solution over 72 hours and to significantly reduce opioid utilization following surgery. -ZYNRELEF was initially approved by the FDA in May 2021 and in December 2021, the FDA approved an expansion of ZYNRELEF's indication. -Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ZYNRELEF is contraindicated for: • Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs,

university chicago professor hospitals patients pittsburgh rush anatomy fda chicago bulls managing partners limitations gi elderly chicago white sox sports medicine orthopaedics nsaids cell biology dala hcl rush university medical center special surgery sigman cabg section head brian cole nonsteroidal boxed warning prescribing information midwest orthopaedics scott sigman associate chairman

Hosted by Dr. Scott Sigman – “Dr. Alexander Sah”

Play Episode Listen Later Jul 13, 2022 27:07

This episode is brought to you by Heron Therapeutics. Please see full Prescribing Information, including Boxed Warning or visit www.ZYNRELEF.com. Dr. Alexander Sah joins for this episode from Sah Orthopaedic Associates at the Institute for Joint Restoration in Fremont, CA. He is an orthopedic surgeon, specializing in minimally invasive hip and knee replacements, knee arthroscopy, as well as complex hip and knee revision surgeries. Topics include: -We hear about his patient-first emphasis with thorough and compassionate care. He has a deep commitment to the Bay Area community going home to practice at the same hospital he was born, Washington Hospital. -We discuss his family influence in becoming a physician with his uncles, grandfather, and father practicing medicine. He completed his orthopedic training at Harvard in Boston and specialized fellowship training in minimally invasive and revision hip and knee surgery at Rush University in Chicago. -Dr. Sah has built his brand with minimally invasive surgery where patients seek him out as a destination practice at Sah Orthopaedic Associates. -We talk ambulatory surgery centers (ASCs) and answer these questions: Is it safe? Is it cost effective? What is the patient satisfaction? -Dr. Sah discusses his interest in orthopedic research and remains active in publishing articles and presenting this work at national meetings. He worked with Heron Therapeutics as an expert in total knee replacement as the company developed the pivotal clinical study program to help inform FDA submissions and meet FDA guidelines for ZYNRELEF. ZYNRELEF utilizes a novel synergistic mechanism of action that combines bupivacaine with a low dose of meloxicam to overcome the challenges of the inflammatory process at the surgical site. ZYNRELEF is the first and only extended-release dual-acting local anesthetic™ (DALA™) and delivers 72 hours of postoperative pain relief via a single needle-free application. It has been clinically proven to better manage pain than standard of care bupivacaine HCl solution over 72 hours and to significantly reduce opioid utilization following surgery. -ZYNRELEF was initially approved by the FDA in May 2021 and in December 2021, the FDA approved an expansion of ZYNRELEF's indication. -Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ZYNRELEF is contraindicated for: • Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF OR history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients • Patients undergoing obstetrical paracervical block anesthesia OR coronary artery bypass graft (CABG) surgery WARNINGS AND PRECAUTIONS include -

chicago harvard patients fda bay area limitations gi elderly severe fremont nsaids dala hcl sah rush university sigman cabg ascs nonsteroidal boxed warning prescribing information scott sigman

Hosted by Dr. Scott Sigman – “Dr. Atiba Jackson”

Medscape InDiscussion: Multiple Myeloma

Play Episode Listen Later Jul 6, 2022 27:41

This episode is brought to you by Heron Therapeutics. Please see full Prescribing Information, including Boxed Warning or visit www.ZYNRELEF.com. If you like happy vibes with a positive patient track record, we've got the orthopedic surgeon for you. Meet Dr. Atiba Jackson from Dayton, OH. He is a Board-Certified Orthopedic Sports Medicine specialist, with fellowship training in sports medicine so he can provide the highest level of care for this brand of injuries. He treats complex shoulder injuries including rotator cuff, labrum, SLAP tears, instability, and dislocations. In addition to treating difficult knee injuries, including ACL tears, ligamentous injuries, meniscus tears, cartilage injuries, he also treats elbow injuries and performs elbow arthroscopy. He cares for arthritis patients, performing replacements of the shoulder, knee, and hip. Topics include: -His family influence in becoming an orthopedic surgeon, as his father is a family practice doctor. Dr. Jackson has strong family ties and we hear the importance of family in this episode. He also became a teenage parent, overcame the adversity and remained focused on becoming an orthopedic surgeon. -Dr. Atiba Jackson helps train the clinical and surgical techniques at the Grandview Orthopedic Residency (DO) program. We hear about the post-grant research position they've developed for those in a bridge year to help them become more of a competitive applicant. -He has social media following for promoting his private practice, Orthopedic Associates, and educating his patients. Dr. Jackson looks like Usher and uses it to his advantage when creating engaging posts. Find out more about Dr. Atiba Jackson here. Also, find out more about Zynrelef here: ZYNRELEF utilizes a novel synergistic mechanism of action that combines bupivacaine with a low dose of meloxicam to overcome the challenges of the inflammatory process at the surgical site. ZYNRELEF is the first and only extended-release dual-acting local anesthetic™ (DALA™) and delivers 72 hours of postoperative pain relief via a single needle-free application. It has been clinically proven to better manage pain than standard of care bupivacaine HCl solution over 72 hours and to significantly reduce opioid utilization following surgery. -ZYNRELEF was initially approved by the FDA in May 2021 and in December 2021, the FDA approved an expansion of ZYNRELEF's indication. -Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use • ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ZYNRELEF is contraindicated for: • Patients with a known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to any local anesthetic agent of the amide-type, NSAIDs, or to any of the other components of ZYNRELEF OR history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients • Patients undergoing obstetrical paracervical blo...

patients fda usher limitations slap gi acl elderly severe nsaids dala hcl atiba sigman cabg nonsteroidal boxed warning prescribing information scott sigman

Triple-Class Refractory Multiple Myeloma: What Is the Approach? What Are the Challenges?

Play Episode Listen Later Jul 5, 2022 21:34

Joseph Mikhael, MD, and Saad Usmani, MD, discuss options in managing triple-class refractory multiple myeloma including selinexor, belantamab mafodotin, and CAR T-cell therapy. Relevant disclosures can be found with the episode show notes on Medscape (https://www.medscape.com/viewarticle/964339). The topics and discussions are planned, produced, and reviewed independently of advertisers. This podcast is intended only for US healthcare professionals. Resources Multiple Myeloma https://emedicine.medscape.com/article/204369-overview Selinexor Prescribing Information https://www.karyopharm.com/wp-content/uploads/2019/07/NDA-212306-SN-0071-Prescribing-Information-01July2019.pdf Belantamab Mafodotin Prescribing Information https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blenrep/pdf/BLENREP-PI-MG.PDF Cytokine Release Syndrome https://emedicine.medscape.com/article/2500111-overview Trending Clinical Topic: CAR T-cell Therapy https://reference.medscape.com/viewarticle/965011 Consensus Recommendations for the Clinical Management of Patients With Multiple Myeloma Treated With Selinexor https://www.karyopharm.com/wp-content/uploads/2020/06/Consensus-Recommendations_June2020.pdf Selinexor, Bortezomib and Dexamethasone: An Effective Salvage Regimen for Heavily Pretreated Myeloma Patients https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8932935/ Once Weekly Selinexor, Carfilzomib, and Dexamethasone (XKd) in Carfilzomib Nonrefractory Multiple Myeloma (MM) Patients. https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.8038 Ide-cel Prescribing Information https://packageinserts.bms.com/pi/pi_abecma.pdf Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma (DREAMM-2): A Two-Arm, Randomised, Open-label, Phase 2 Study https://linkinghub.elsevier.com/retrieve/pii/S1470-2045(19)30788-0 DREAMM Trials https://dreammtrials.com/ Blenrep (Belantamab Mafodotin) REMS https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=403 Band Keratopathy https://emedicine.medscape.com/article/1194813-overview Cilta-cel Prescribing Information https://www.fda.gov/media/156560/download BCMA-Directed CAR T-cell Therapy in Adult Patients With Relapsed and/or Refractory Multiple Myeloma https://clinicaltrials.gov/ct2/show/NCT04318327

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What Veterinarians Need to Know About Resistant Heartworms with Dr. Savadelis

Clinician's Brief: The Podcast

Play Episode Listen Later Jun 20, 2022 24:59

Bacteria aren't the only organisms developing resistance to today's pharmaceuticals. In this episode of the Clinician's Brief Partner Podcast, heartworm disease research scientist Molly Savadelis, PhD, talks with host Beth Molleson, DVM, about the changing landscape of heartworm disease and what recommendations veterinarians should be making to keep their patients protected from one of the companion animals' most infamous parasites.IMPORTANT SAFETY INFORMATION: Use PROHEART 6 in dogs 6 months of age or older and PROHEART 12 in dogs 12 months of age or older. Do not administer to dogs that are sick, debilitated, underweight, have a history of weight loss, or to those previously found to be hypersensitive to the drug. Hypersensitivity reactions may occur in some dogs when PROHEART is administered alone or with vaccines. Anaphylactic and anaphylactoid reactions can result in death and should be treated immediately with the same measures used to treat hypersensitivity reactions to vaccines and other injectable products. Reported side effects in clinical trials included vomiting, lethargy, diarrhea, anorexia, and hypersensitivity reactions. People should avoid inhalation, contact with eyes, or accidental self-injection. Certification is required before veterinarians and staff administer these products. See full Prescribing Information at ProHeart6PI.com and ProHeart12PI.com.IMPORTANT SAFETY INFORMATION: Use with caution in dogs with a history of seizures. Simparica Trio contains sarolaner, a member of the isoxazoline class, which has been associated with neurologic adverse reactions in dogs with or without a history of neurologic disorders. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. See full Prescribing Information at SimparicaTrioPI.com.Contact us:Podcast@briefmedia.comWhere to find us:Cliniciansbrief.com/podcastsFacebook.com/clinciansbriefTwitter: @cliniciansbriefInstagram: @clinicians.briefThe Team:Beth Molleson, DVM - HostSarah Pate - Producer & Project Manager, Marketing ServicesRandall Stupka - Podcast Production & Sound Editing

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Episode 96 - Tirzepatide

Rio Bravo qWeek

Play Episode Listen Later Jun 3, 2022 22:54

Episode 96: Tirzepatide. By Maria Beuca, MS3, Ross University School of Medicine. Comments by Hector Arreaza, MD. Today is May 19, 2022, and we want to talk about a new drug that was recently approved by the FDA on May 13, 2022, for the treatment of type 2 diabetes. This is Rio Bravo qWeek Podcast, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California. Our program is affiliated with UCLA, and it's sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home.This podcast was created for educational purposes only. Visit your primary care physician for additional medical advice.This drug is known as tirzepatide, also known by the brand name Mounjaro®. It is an injection given once a week that mimics the effects of two hormones: GIP (Glucose-dependent Insulinotropic Polypeptide) and GLP-1 (Glucagon-Like Peptide-1). These two hormones are involved in lowering blood glucose levels after eating by stimulating insulin release, they are “incretin” hormones. What is unique about this new drug, tirzepatide, is that it is the first and only approved single molecule that binds and activates BOTH GIP and GLP-1 receptors. Because of this dual incretin action, it has also been referred to as a “twincretin.” It increases first and second-phase insulin secretion AND decreases glucagon levels in a glucose-dependent manner, and this lowers both fasting blood glucose levels and post-meal glucose levels. It is also an appetite suppressant, causing significant weight loss in patients with type 2 diabetes. Tirzepatide vs semaglutide: Semaglutide (Ozempic®) was approved for the treatment of type 2 Diabetes in December 2017, and then approved for weight loss in June 2021 under the brand name Wegovy®. Semaglutide is a GLP-1 receptor agonist, but it does not work on GIP receptors. Due to this dual incretin action of tirzepatide, it has now been shown to be superior at all doses to semaglutide. Evidence: There was a 40-week study done in July 30, 2019- February 15, 2021, called “SURPASS-2” where 1879 patients were assigned in a 1:1:1:1 ratio to either semaglutide 1 mg or to the 3 different doses of tirzepatide (5 mg, 10 mg, 15 mg). The patients all had a mean HbA1c of 8.28% at the start of the study. By the end of the study, the patients on tirzepatide at the different doses had an A1c of 6.2% for the 5mg dose, 6 % for the 10 mg dose, and 5.9% for the 15 mg dose, whereas the patients on semaglutide had their HbA1c at 6.42%. On tirzepatide, about 82-86% of patients decreased their HbA1c below 7.0%, compared to 79% of the patients on semaglutide. Comment: It seems like a race: All GLP-1 RA are competing to reach the lowest A1C and get the lowest weight. What is more amazing is that up until now, an A1c level < 5.7% without a risk of hypoglycemia was not considered attainable with current treatment options, but with tirzepatide, this goal was met. Fasting Serum glucose levels prior to treatment: 173. Fasting Serum glucose after treatment with:Tirzepatide 5 mg: 117.0, 10 mg: 111.3, 15 mg: 109.6. Semaglutide 1 mg: 124.4.Comment: No hypoglycemia. Weight loss for patients on Tirzepatide was also greater, patients lost about 4 to 12 lbs more (1.9 to 5.5 kg) than with semaglutide. Weight loss in 40 weeks: Tirzepatide: 5mg: 16 lbs (7.6 kg), 10 mg: 20 lbs (9.3 kg), 15 mg: 24 lbs (11.2 kg). Semaglutide: 12 lbs (5.7 kg). Other positive effects that many patients experience were: improved lipid profile, blood pressure, liver enzymes, and improved biomarkers of insulin sensitivity. Another Phase 3 clinical trial of tirzepatide that is currently ongoing is the SURMOUNT-1, which focuses on the weight loss benefits of the drug, and results are expected in 2023. Preliminary data shows that tirzepatide has similar weight loss as bariatric surgery. Cost: Tirzepatide (Mounjaro) is a rival for Novo Nordisk's semaglutide sold as Ozempic and Wegovy. Institute for Clinical and Economic Review (ICER) released the final report for tirzepatide cost: $5,500-5,700/year. Semaglutide: Ozempic, Wegovy ~ $16,000/year without insurance. Comment: [3 times cheaper]. 4x more expensive in the US, rarely covered by health insurance for weight loss Administration: 1x week, any time, with or without meals. Doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. Week 1-Week 4: Start with 2.5 mg injection 1x week. Treatment initiation, not intended for glycemic control. Week 5-Week 8: Increase to 5.0 mg 1x week. >Week 9: may increase dose another 2.5 mg every 4 weeks as needed for glycemic control. Maximum dose: 15 mg 1x week. Adverse Reactions: Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, abdominal pain. Drug Interactions: Delays gastric emptying, can affect absorption of oral medications taken at the same time. Warfarin = monitor more closely. Contraindications: Type 1 diabetes, pregnancy, personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2: medullary thyroid cancer, parathyroid tumors, and pheochromocytoma). Thyroid c-cell tumors were noticed in rats. Symptoms of thyroid cancer: mass in neck, dysphagia, dyspnea, persistent hoarseness. Warnings & Precautions:Pancreatitis: Has been reported in clinical trials. Discontinue if suspected. Hypoglycemia: May cause hypoglycemia if used with insulin or insulin secretagogues (sulfonylurea). Reducing dose of these may be necessary.Hypersensitivity is possible.Acute Kidney Injury: No dosage adjustment needed, but monitor renal function if patient has renal impairment with severe GI reactions. It may cause nausea, vomiting and diarrheaà dehydrationà acute kidney injury. Can worsen chronic renal disease or renal impairment.Severe gastrointestinal disease: May cause Gastrointestinal adverse reactions, sometimes severe. Not recommended in patients with severe gastrointestinal disease, may aggravate symptoms, has not been studied.Acute gallbladder disease: Also has occurred in 0.6% of patients in trials. monitor and follow-up if cholelithiasis is suspected. Diabetic retinopathy: Not studied, monitor for complications. Rapid glucose control can cause temporary worsening of diabetic retinopathy, monitor these patients. Pregnancy: May cause fetal harm.Females of Reproductive potential: If using oral contraceptives, switch to non-oral contraceptive or add a barrier method for 4 weeks after starting drug and for 4 weeks after increasing dose.____________________________Now we conclude our episode number 96 “Tirzepatide.” Maria explained that tirzepatide has a dual effect on both GLP-1 and GIP receptors. The medication has been approved for the treatment of type 2 diabetes, but it has been proven to be very effective for weight loss also, almost comparable to bariatric surgery. Remember the contraindications and side effects of this medication to use it appropriately. The good news with tirzepatide is the cost —almost 3 times lower cost than its main competitor. Even without trying, every night you go to bed being a little wiser.This week we thank Hector Arreaza and Maria Beuca.Audio edition: Suraj Amrutia. Thanks for listening to Rio Bravo qWeek Podcast. If you have any feedback, contact us by email at RioBravoqWeek@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. See you next week! _____________________References:Dockrill, Peter. “Experimental Drug Breaks Record for Weight Loss in Latest Clinical Trial Results.” ScienceAlert, 9 May 2022, https://www.sciencealert.com/experimental-drug-breaks-record-for-weight-loss-in-latest-clinical-trial-results.Frías, Juan P., et al. “Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes: Nejm.” New England Journal of Medicine, 5 Aug. 2021, https://www.nejm.org/doi/full/10.1056/NEJMoa2107519. “Label as Approved by FDA. - Pi.lilly.com.” Mounjaro Prescribing Information, Lilly USA, LLC, May 2022, https://pi.lilly.com/us/mounjaro-uspi.pdf. Mounjaro. Prescribing Information. Lilly USA, LLC. May 2022. https://pi.lilly.com/us/mounjaro-uspi.pdf?s=pi

115. Apoquel® and Cytopoint's effect on allergic inflammation

The Derm Vet Podcast

Play Episode Listen Later May 12, 2022 20:28

Welcome Valerie Fadok, DVM, PhD, DACVD to the podcast to discuss canine allergic and atopic dermatitis! She is a senior veterinary dermatologist with Zoetis.We've come a long way in our ability to manage allergic skin diseases in dogs. Due to our increased knowledge based on research, there are better therapeutics available. We have learned that several Type 2 cytokines such as IL-2, IL-4, IL-6, IL-13, and IL-31 are major players in mediating allergic pruritus and inflammation. These cytokines mediate their action through Janus kinase-1 and appear early in the allergic inflammation cascade. It is so important with the management of allergic and atopic dogs that we continue to have studies showing the effect of therapies on itch and inflammation. Check out this episode of the podcast to learn more!This podcast was sponsored by Zoetis. Zoetis is dedicated to changing the way we approach canine pruritus to protect the bonds between the pet, the owner and the veterinary team. Visit ScienceofStrongerBonds.com for more information.APOQUEL-IMPORTANT SAFETY INFORMATIONDo not use Apoquel in dogs less than 12 months of age or those with serious infections. Apoquel may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. Apoquel has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. Apoquel has been used safely with many common medications including parasiticides, antibiotics and vaccines. For more information, please see the full Prescribing Information at Apoquel.com/pi.Apoquel IndicationsControl of pruritus (itching) associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Cytopoint Indications: Cytopoint has been shown to be effective for the treatment of dogs against allergic dermatitis and atopic dermatitis.

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The Impact of BRCA Status on Therapy Choices

Medscape InDiscussion: Breast Cancer

Play Episode Listen Later Apr 12, 2022 21:21

Drs Lidia Schapira and Nadine Tung discuss how BRCA status affects choosing therapy for patients with early-stage breast cancer. Relevant disclosures can be found with the episode show notes on Medscape.com (https://www.medscape.com/viewarticle/963168). The topics and discussions are planned, produced, and reviewed independently of advertisers. This podcast is intended only for US healthcare professionals. Resources TBCRC 031: Randomized Phase II Study of Neoadjuvant Cisplatin Versus Doxorubicin-Cyclophosphamide in Germline BRCA Carriers With HER2-Negative Breast Cancer (the INFORM trial) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8462533/ Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer https://www.nejm.org/doi/full/10.1056/NEJMoa2105215 Validation of a Novel Staging System for Disease-Specific Survival in Patients With Breast Cancer Treated With Neoadjuvant Chemotherapy https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107758/ Table 1 from Validation of a Novel Staging System for Disease-Specific Survival in Patients With Breast Cancer Treated With Neoadjuvant Chemotherapy https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3107758/table/T1/?report=objectonly Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2−, Node-Positive, High-Risk, Early Breast Cancer (monarchE) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768339/ Evaluation of Efficacy and Safety of PARP Inhibitors in Breast Cancer: A Systematic Review and Meta-analysis https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8215282/pdf/main.pdf LYNPARZA® (olaparib) Prescribing Information. AstraZeneca; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208558s014lbl.pdf Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline https://ascopubs.org/doi/full/10.1200/JCO.20.00299 A Population-Based Study of Genes Previously Implicated in Breast Cancer https://www.nejm.org/doi/full/10.1056/NEJMoa2005936 TBCRC 048: Phase II Study of Olaparib for Metastatic Breast Cancer and Mutations in Homologous Recombination-Related Genes https://ascopubs.org/doi/10.1200/JCO.20.02151 Cancer Risks and Mortality in Heterozygous ATM Mutation Carriers https://academic.oup.com/jnci/article/97/11/813/2521263?login=false Neoadjuvant Talazoparib in Patients With Germline BRCA1/2 (gBRCA1/2) Mutation-Positive, Early HER2-Negative Breast Cancer (BC): Results of a Phase 2 Study https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.505

Improved pain relief and opioid reduction in joint arthroplasty procedures with ZYNRELEF® extended-release solution. Sponsored by Heron Therapeutics.

Eastern Ortho On Call

Play Episode Listen Later Feb 22, 2022 33:36

Join orthopedic surgeons Dr. Alan Rechter and Dr. Alex Sah for an engaging conversation about improved pain relief and reduction of opioids and narcotics provided by ZYNRELEF ® (bupivacaine and meloxicam) extended-release solution used in conjunction with joint arthroplasty surgery. Heron Therapeutics received an FDA approval of a significant indication expansion for ZYNRELEF on December, 9 2021. This label expansion now indicates ZYNRELEF for the postoperative pain treatment of adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. For more information, please visit: https://zynrelef.com/ For safety information, please visit: https://zynrelef.com/prescribing-information.pdf Please see below for Important Safety Information ZYNRELEF is approved for use in adults to reduce pain for up to 3 days after foot and ankle surgeries, small-to-medium open abdominal surgeries, and total joint replacement surgeries of the lower extremity. ZYNRELEF is applied into the wound at the time of surgery. Important Safety Information ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which: Can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID Cannot be used during heart bypass surgery. Can increase the risk of gastrointestinal bleeding, ulcers, and tears. ZYNRELEF should also not be used: if you are allergic to any component of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines. as a paracervical block, during childbirth. The most common side effects of ZYNRELEF are constipation, vomiting, and headache. The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you. Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning.

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Ep. 157 "Managing Psoriasis with Confidence: Maureen's Career and Treatment Journey" An Amgen sponsored podcast.

Play Episode Listen Later Feb 1, 2022 13:05

For years, Maureen struggled with symptoms of plaque psoriasis while on the job as an attorney. Hear Maureen's story on learning to advocate for herself and pushing for change in her treatment routine. This episode is sponsored by Amgen. For Important Safety Information https://bit.ly/2CzZ6Ym and for Prescribing Information https://bit.ly/3hclnuA .

career confidence managing treatments symptoms oral arthritis psoriasis plaque amgen psoriatic prescribing information

Review Regimens for the Treatment of Relapsed/Refractory Multiple Myeloma

Play Episode Listen Later Oct 20, 2021

Have you considered POMALYST® (pomalidomide) containing regimens for your appropriate patients with relapsed/refractory multiple myeloma who have received lenalidomide and a proteasome inhibitor? Tune in to hear key findings from clinical trials, including safety and efficacy data, and other important information regarding these treatment regimens. Please see full Prescribing Information for POMALYST, including Boxed WARNINGS, and full Prescribing Information for EMPLICITI. POMALYST and EMPLICITI Indications POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. EMPLICITI® (elotuzumab) is indicated in combination with POMALYST and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. POMALYST + dexamethasone + daratumumab Indication POMALYST + dexamethasone + daratumumab is indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Information about POMALYST + dexamethasone + ...

treatments rmd multiple myeloma refractory relapsed reachmd oncology and hematology prescribing information medical industry feature oncology - hematology

75. Fetch the Best- How to Successfully use Apoquel® and Cytopoint to Manage Allergic Dogs

The Derm Vet Podcast

Play Episode Listen Later Aug 5, 2021 48:06

Apoquel® (oclacitinib tablet) and Cytopoint are tremendous tools in the management of allergic and atopic dermatitis in dogs. On this episode of The Derm Vet podcast, I got to discuss both of these therapies with Dr. Dana Liska, DVM, DACVD. Dr. Liska is a senior veterinary specialist in dermatology with Zoetis Petcare. Learn how these therapies can be successfully utilized during the canine allergic workup and provide relief from pruritus. This podcast was sponsored by Zoetis. Zoetis is dedicated to changing the way we approach canine pruritus to protect the bonds between the pet, the owner and the veterinary team. Visit ScienceofStrongerBonds.com for more information.Apoquel-Important Safety InformationDo not use APOQUEL in dogs less than 12 months of age or those with serious infections. APOQUEL may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. APOQUEL has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. APOQUEL has been used safely with many common medications including parasiticides, antibiotics and vaccines. For more information, please see the full Prescribing Information at APOQUEL.com.APOQUEL® IndicationsControl of pruritus (itching) associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Cytopoint Indications: CYTOPOINT has been shown to be effective for the treatment of dogs against allergic dermatitis and atopic dermatitis.

dogs manage successfully allergies itch canine fetch allergic veterinary dvm zoetis atopic dermatitis liska pruritus prescribing information apoquel derm vet

Case Studies Addressing Modern Care Challenges with Painful Diabetic Peripheral Neuropathy of the Feet

Play Episode Listen Later Jul 30, 2021

Host: David M. Simpson, MD Guest: David R. Walega, MD Guest: Eric J. Viel, MD, PhD Find the full Prescribing Information here. What are some of the current challenges in treating patients with painful diabetic peripheral neuropathy, and how can we overcome them? Explore those questions and more through the lens of patient case studies with Dr David M. Simpson, Dr Eric Viel, and Dr David Walega. Here to walk us through the clinical trial data that led to the FDA approval of a treatment option for painful diabetic peripheral neuropathy of the feet is Dr David M. Simpson, a Professor of Neurology at the Icahn School of Medicine and Director of the Clinical Neurophysiology Laboratories and Neuromuscular Division at Mount Sinai in New York. QUTENZA® is a registered trademark of Averitas Pharma, Inc.© 2021 Averitas Pharma, Inc. All rights reserved.M-QZA-US-01-21-0060 July 2021

73. Itchy Pet Awareness Month

The Derm Vet Podcast

Play Episode Listen Later Jul 23, 2021 36:25

August is Itchy Pet Awareness Month! This is the third year of raising awareness for itchy pets and what veterinarians can do to help provide fast relief. On this episode of the podcast, I welcome Dr. Michele Rosenbaum, VMD, DACVD (Medical Lead for Dermatology at Zoetis Petcare) and Cammie Johnson (Senior Marketing Manager for Dermatology at Zoetis Petcare). Hear about all the fun things you can do to celebrate Itchy Pet Awareness Month in the clinic to help educate owners!Check out these great resources mentioned within the episode:ItchyPetAwarenessMonth.comItchingForHelp.comZoetisPetCare.comScienceOfStrongerBonds.comLetsTalkAllergicItch.comThis podcast was sponsored by Zoetis, the makers of treatments including APOQUEL (oclacitinib tablet) and CYTOPOINT. Zoetis is dedicated to changing the way we approach canine pruritus to protect the bonds between the pet, the owner and the veterinary team. Visit ScienceofStrongerBonds.com for more information.Apoquel-Important Safety InformationDo not use APOQUEL in dogs less than 12 months of age or those with serious infections. APOQUEL may increase the chances of developing serious infections, and may cause existing parasitic skin infestations or pre-existing cancers to get worse. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. New neoplastic conditions (benign and malignant) were observed in clinical studies and post-approval. APOQUEL has not been tested in dogs receiving some medications including some commonly used to treat skin conditions such as corticosteroids and cyclosporines. Do not use in breeding, pregnant, or lactating dogs. Most common side effects are vomiting and diarrhea. APOQUEL has been used safely with many common medications including parasiticides, antibiotics and vaccines. For more information, please see the full Prescribing Information at APOQUEL.com.

dogs itch awareness month dermatology itchy zoetis animal hospital vmd prescribing information apoquel

Best Practices for Administering Prescription Strength Capsaicin for Painful DPN of the Feet

Play Episode Listen Later Jul 13, 2021

Guest: David M. Simpson, MD Guest: Jon T. Gertken, MD Guest: Stephanie Simon, NP Find the full Prescribing Information here. There are multiple ways to incorporate the use of Qutenza, a topical treatment for painful diabetic peripheral neuropathy of the feet, into practice. Tune in to hear Dr. David M. Simpson, Dr. Jon T. Gertken, and Ms. Stephanie Simon share their best practices for administering Qutenza as well as the management of painful diabetic peripheral neuropathy of the feet. QUTENZA® is a registered trademark of Averitas Pharma, Inc.© 2021 Averitas Pharma, Inc. All rights reserved.M-QZA-US-01-21-0065 June 2021

ms strength feet best practices simpson painful prescription pain management endocrinology anesthesiology david m rmd podiatry administering capsaicin reachmd general medicine and primary care neurology and neurosurgery diabetes and endocrinology stephanie simon prescribing information medical industry feature diabetes discourse

Best Practices for Administering Prescription Strength Capsaicin for Painful DPN of the Feet

Diabetes Discourse

Play Episode Listen Later Jul 13, 2021

Guest: David M. Simpson, MD Guest: Jon T. Gertken, MD Guest: Stephanie Simon, NP Find the full Prescribing Information here. There are multiple ways to incorporate the use of Qutenza, a topical treatment for painful diabetic peripheral neuropathy of the feet, into practice. Tune in to hear Dr. David M. Simpson, Dr. Jon T. Gertken, and Ms. Stephanie Simon share their best practices for administering Qutenza as well as the management of painful diabetic peripheral neuropathy of the feet. QUTENZA® is a registered trademark of Averitas Pharma, Inc.© 2021 Averitas Pharma, Inc. All rights reserved.M-QZA-US-01-21-0065 June 2021

ms strength feet best practices simpson painful prescription pain management endocrinology anesthesiology david m rmd podiatry administering capsaicin reachmd general medicine and primary care neurology and neurosurgery diabetes and endocrinology stephanie simon prescribing information medical industry feature diabetes discourse

Addressing Questions Regarding Long-Term Treatment with a TPRV1 Agonist for Painful DPN of the Feet

Play Episode Listen Later Jul 13, 2021

Host: David M. Simpson, MD Guest: Serge Perrot, MD, PhD Dive into the data from an international trial evaluating the long-term safety and tolerability of a treatment option for painful diabetic peripheral neuropathy of the feet with Dr. David M. Simpson, a Professor of Neurology at Icahn School of Medicine at Mount Sinai, and Professor Serge Perrot, a Professor of Clinical Pharmacology at Paris Descartes University. Find the full Prescribing Information here. QUTENZA® is a registered trademark of Averitas Pharma, Inc.© 2021 Averitas Pharma, Inc. All rights reserved.M-QZA-US-01-21-0073 June 2021

professor medicine md treatments addressing feet long term simpson painful neurology mount sinai pain management endocrinology anesthesiology david m icahn school rmd podiatry clinical pharmacology agonist reachmd general medicine and primary care neurology and neurosurgery diabetes and endocrinology prescribing information medical industry feature

Capsaicin 8% Topical System: An Advancement in the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet

Play Episode Listen Later Jul 13, 2021

Host: David M. Simpson, MD Guest: Rory Abrams, MD Find the full Prescribing Information here. The STEP trial was the first-ever study assessing the efficacy and safety of the capsaicin 8% topical system for patients living with painful diabetic peripheral neuropathy (PDPN) of the feet. Here to share key findings from the trial and what this treatment might mean for our patients are Dr. David M. Simpson, principal investigator of the STEP trial, and Dr. Rory Abrams, an expert neurologist and author of a recent high-concentration capsaicin 8% topical system review paper. QUTENZA® is a registered trademark of Averitas Pharma, Inc. © 2021 Averitas Pharma, Inc. All rights reserved. M-QZA-US-01-21-0048 June 2021

system treatments feet simpson painful advancement pain management topical diabetic endocrinology anesthesiology david m rmd podiatry peripheral neuropathy capsaicin reachmd general medicine and primary care neurology and neurosurgery diabetes and endocrinology prescribing information medical industry feature

TMBS E99: Dr Denise Yardley, Good News for Cancer Patients

The Mark Bishop Show

Play Episode Listen Later May 31, 2021 13:40

POSITIVE NEWS CONTINUES TO EMERGE FOR ADVANCED BREAST CANCER PATIENTS KISQALI EXPLORATORY SUBGROUP ANALYSIS FROM MONALEESA-3 AND MONALEESA-7, RESULTS ADD TO BODY OF OVERALL SURVIVAL EVIDENCE Denise Yardley, MD, Principal Investigator, Sarah Cannon Research InstituteThere are approximately 155,000 individuals in the US are living with metastatic breast cancer. Up to 11% of new breast cancer cases are initially stage IV or metastatic. Nearly 30% of women initially diagnosed with the early-stage disease will ultimately develop metastatic lesions, often months or even years later.  And as of 2017, in the United States, nearly 1 in 7 women with metastatic BC were younger than 50. ......Denise Yardley, MD, is the Principal Investigator for the Sarah Cannon Research Institute.Indication KISQALI® (ribociclib) is a prescription medicine used in combination with:• an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic), as the first endocrine-based therapy; or• fulvestrant to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer as the first endocrine-based therapy or with disease progression following endocrine therapy. It is not known if KISQALI is safe and effective in children. IMPORTANT SAFETY INFORMATION What is the most important information I should know about KISQALI? KISQALI may cause serious side effects, including: Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including: trouble breathing or shortness of breath cough with or without mucus chest pain Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your health care provider should check your heart and do blood tests before and during treatment with KISQALI. Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.  Liver problems (hepatobiliary toxicity). KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems: yellowing of your skin or the whites of your eyes (jaundice) dark or brown (tea-colored) urine feeling very tired loss of appetite pain on the right side of your stomach area (abdomen) bleeding or bruising more easily than normal  Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills. Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI.   What should I tell my health care provider before taking KISQALI? Before you take KISQALI, tell your health care provider if you: have any heart problems, including heart failure, irregular heartbeats, and QT prolongation have ever had a heart attack have a slow heartbeat (bradycardia) have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood have fever, chills, or any other signs or symptoms of infection have liver problems  have any other medical conditions are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI. Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI. Talk to your health care provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your health care provider right away. are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI  Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KISQALI and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine. What should I avoid while taking KISQALI?  Avoid eating grapefruit and avoid drinking grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood. KISQALI may cause fertility problems if you are male and take KISQALI. This may affect your ability to father a child. Talk to your health care provider if this is a concern for you. Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see accompanying full Prescribing Information. References Yardley, Denise, A. et. al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (Mets), including those with liver Mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology (ASCO) meeting (Abstract #1054). Wang, R., Zhu, Y., Liu, X. et al. The Clinicopathological features and survival outcomes of patients with different metastatic sites in stage IV breast cancer. BMC Cancer 19, 1091 (2019). National Cancer Institute. Dictionary of Cancer Terms. Available at:  https://www.cancer.gov/publications/dictionaries/cancer-terms/def/visceral. Accessed November 2018.

TMBS E99: Dr Denise Yardley, Good News for Cancer Patients

The Mark Bishop Show

Play Episode Listen Later May 31, 2021 13:40

POSITIVE NEWS CONTINUES TO EMERGE FOR ADVANCED BREAST CANCER PATIENTS KISQALI EXPLORATORY SUBGROUP ANALYSIS FROM MONALEESA-3 AND MONALEESA-7, RESULTS ADD TO BODY OF OVERALL SURVIVAL EVIDENCE Denise Yardley, MD, Principal Investigator, Sarah Cannon Research InstituteThere are approximately 155,000 individuals in the US are living with metastatic breast cancer. Up to 11% of new breast cancer cases are initially stage IV or metastatic. Nearly 30% of women initially diagnosed with the early-stage disease will ultimately develop metastatic lesions, often months or even years later.  And as of 2017, in the United States, nearly 1 in 7 women with metastatic BC were younger than 50. ......Denise Yardley, MD, is the Principal Investigator for the Sarah Cannon Research Institute.Indication KISQALI® (ribociclib) is a prescription medicine used in combination with:• an aromatase inhibitor to treat pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic), as the first endocrine-based therapy; or• fulvestrant to treat postmenopausal women with HR-positive, HER2-negative metastatic breast cancer as the first endocrine-based therapy or with disease progression following endocrine therapy. It is not known if KISQALI is safe and effective in children. IMPORTANT SAFETY INFORMATION What is the most important information I should know about KISQALI? KISQALI may cause serious side effects, including: Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your health care provider right away if you have any new or worsening symptoms, including: trouble breathing or shortness of breath cough with or without mucus chest pain Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your health care provider should check your heart and do blood tests before and during treatment with KISQALI. Tell your health care provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint.  Liver problems (hepatobiliary toxicity). KISQALI can cause serious liver problems. Your health care provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your health care provider right away if you get any of the following signs and symptoms of liver problems: yellowing of your skin or the whites of your eyes (jaundice) dark or brown (tea-colored) urine feeling very tired loss of appetite pain on the right side of your stomach area (abdomen) bleeding or bruising more easily than normal  Low white blood cell counts (neutropenia). Low white blood cell counts are very common when taking KISQALI and may result in infections that may be severe. Your health care provider should check your white blood cell counts before and during treatment with KISQALI. Tell your health care provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills. Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking KISQALI if you develop certain serious side effects during treatment with KISQALI.   What should I tell my health care provider before taking KISQALI? Before you take KISQALI, tell your health care provider if you: have any heart problems, including heart failure, irregular heartbeats, and QT prolongation have ever had a heart attack have a slow heartbeat (bradycardia) have problems with the amount of potassium, calcium, phosphorus, or magnesium in your blood have fever, chills, or any other signs or symptoms of infection have liver problems  have any other medical conditions are pregnant, or plan to become pregnant. KISQALI can harm your unborn baby If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with KISQALI. Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI. Talk to your health care provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your health care provider right away. are breastfeeding or plan to breastfeed. It is not known if KISQALI passes into your breast milk. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI  Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KISQALI and other medicines may affect each other, causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine. What should I avoid while taking KISQALI?  Avoid eating grapefruit and avoid drinking grapefruit juice during treatment with KISQALI since these may increase the amount of KISQALI in your blood. KISQALI may cause fertility problems if you are male and take KISQALI. This may affect your ability to father a child. Talk to your health care provider if this is a concern for you. Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of KISQALI. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see accompanying full Prescribing Information. References Yardley, Denise, A. et. al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (Mets), including those with liver Mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology (ASCO) meeting (Abstract #1054). Wang, R., Zhu, Y., Liu, X. et al. The Clinicopathological features and survival outcomes of patients with different metastatic sites in stage IV breast cancer. BMC Cancer 19, 1091 (2019). National Cancer Institute. Dictionary of Cancer Terms. Available at:  https://www.cancer.gov/publications/dictionaries/cancer-terms/def/visceral. Accessed November 2018.

Treatment Considerations for Urgent Warfarin Reversal

Play Episode Listen Later May 12, 2021

Host: Jennifer Caudle, DO Guest: Michelle Kincaid, MD Guest: David M. Janicke, MD What do we need to know about Kcentra®, Prothrombin Complex Concentrate (Human), and its role in coagulation factor replacement for acute deficiencies? Joining Dr. Jennifer Caudle to explore that question and more through the lens of a patient case are emergency medicine specialist Dr. David Janicke and critical care surgeon Dr. Michelle Kincaid. Please read full Prescribing Information for Kcentra®. KCT-0052-APR21

md treatments surgery considerations urgent reversal emergency medicine critical care anesthesiology rmd warfarin reachmd general medicine and primary care host jennifer caudle neurology and neurosurgery kct prescribing information medical industry feature

Evaluating Strategies for Warfarin Reversal

Play Episode Listen Later May 12, 2021

Host: Jennifer Caudle, DO Guest: Aryeh Shander, MD, FCCM, FCCP Bleeding is the most common complication of anticoagulant use. And to better care for patients either experiencing acute bleeding or urgently needing surgery, it's critical that clinicians thoroughly understand how to assess, treat, and reverse anticoagulation. Dr. Jennifer Caudle sits down with Dr. Aryeh Shander to discuss some of the different considerations we should take into account when selecting a warfarin reversal option. Please read full Prescribing Information for Kcentra®. KCT-0033-APR21

strategy md surgery evaluating reversal emergency medicine critical care anesthesiology rmd warfarin reachmd general medicine and primary care host jennifer caudle neurology and neurosurgery kct prescribing information medical industry feature

A Look at the Clinical Trial Data on a Treatment for Painful Diabetic Peripheral Neuropathy of the Feet