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Drug Information Center Highlights of FDA Activities – 2/1/21 – 2/28/21

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Drug Information Center Highlights of FDA Activities – 2/1/21 – 2/28/21 Drug Information Center Highlights of FDA Activities – 2/1/21 – 2/28/21 FDA Drug Safety Communications & Drug Information Updates: Increased Risk of Heart‐related Problems and Cancer with Tofacitinib – Drug Safety Communication 2/4/21 The FDA alerted the public that preliminary results from a safety clinical trial found an increased risk serious heart‐ related problems and cancer were observed with the use of tofacitinib (Xeljanz, Xeljanz XR) compared with tumor necrosis factor (TNF) inhibitors. The benefits and risks should be considered when deciding to prescribe or continue this medication until final study results are available. Recommendations in the prescribing information should continue to be followed. Risks Associated with Compounding Remdesivir Drug Products 2/4/21 Following approval of remdesivir (Veklury), the FDA cautioned against compounding remdesivir drug products due to complexities related to the quality and sourcing of the remdesivir active pharmaceutical ingredient. The structure is complex, with six stereocenters, and the pH of the formulation of the approved drug is critical to ensure stability. USP standards are not available. Emergency Use Authorization for Monoclonal Antibodies for Treatment of COVID‐19 2/9/21 The FDA issued an emergency use authorization for bamlanivimab and etesevimab together for treatment of mild to moderate COVID‐19 in adults and pediatric patients, to reduce risk of hospitalization or death. The treatment is not authorized for use in hospitalized patients or patients who require oxygen due to COVID‐19. Pulse Oximeter Accuracy and Limitations: FDA Safety Communication 2/19/21 The FDA has issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. The safety communication provides recommendations for patients and providers regarding how to use pulse oximeters, and instructions for reporting problems with pulse oximeters to the FDA. Flexible Storage, Transportation Conditions for Pfizer‐BioNTech COVID‐19 Vaccine 2/25/21 The FDA allowed undiluted frozen vials of the Pfizer‐BioNTech COVID‐19 vaccine to be transported and stored at conventional freezer temperatures for up to 2 weeks. Vials may be stored at ‐25°C to ‐15°C (‐13°F to 5°F) for up to 2 weeks. Vials stored at these temperatures may be returned one time to the recommended storage condition of ‐ 80°C to ‐60°C (‐112°F to ‐76°F); total time at the higher temperature should be tracked and should not exceed 2 weeks. See the EUA Fact Sheet for additional storage and transport conditions. Emergency Use Authorization for Janssen COVID‐19 Vaccine 2/27/21 The FDA issued an emergency use authorization allowing for the use of the Janssen (Johnson & Johnson) COVID‐19 vaccine in individuals 18 years of age and older. Major Medication/Drug‐Related Product Recalls Announced Through MedWatch: Enoxaparin Sodium Injection USP, Apotex: Recall – Mislabeled Syringe Barrel Measurement Markings 2/4/21 Apotex recalled 2 batches (CS008, CT003) of enoxaparin sodium injection USP due to a packaging error resulting in some syringe barrels containing 150 mg/mL markings instead of 100 mg/mL markings on the syringe barrel and vice versa. Medfusion 3500 and 4000 Syringe Pumps, Smiths Medical: Recall – Risk of Medication Delivery Error 2/10/21 Smiths Medical recalled specific software versions of the Medfusion 3500 and 4000 Syringe Pumps because of a software error that may lead to over‐delivery or under‐delivery of fluids or medication. FDA Activity Newsletter WSU Drug Information Center February 2021 Page | 2 Dietary Supplement Recalls & Public Notifications Notifications were issued regarding undeclared active ingredients or contaminants in the following products. Patients are advised not to purchase or use these products. Product Promoted Use Undeclared Ingredient(s) or Contaminants Adam’s Secret Extra Strength 1500 Sexual Enhancement Sildenafil and/or tadalafil Capsule* Adam’s Secret Extra Strength 3000 Sexual Enhancement Sildenafil and/or tadalafil Capsule* ManukaGuard Allercleanse Nasal Spray* Clean nasal passages Yeast *recalled New Product Shortages Date Initially Posted Calcium disodium versenate injection 2/2/21 Succimer capsules 2/26/21 Brand Name or Sole Source Product Discontinuations/Withdrawals Date Posted Efavirenz, emtricitabine, tenofovir disoproxil fumarate tablets (Atripla, Gilead Sciences) 2/4/21 New Drug Approvals: Description (see attached drug summaries) Date Approved Tepotinib / Tepmetko / EMD Serono Inc Kinase inhibitor for the treatment of metastatic non‐small 2/3/21 cell lung cancer in patients harboring mesenchymal‐ epithelial transition (MET) exon 14 skipping alterations Lisocabtagene maraleucel / Breyanzi / Customized biologic cell‐based gene therapy, a chimeric 2/5/21 Juno Therapeutics antigen receptor (CAR) T cell therapy, to treat adults with diffuse large B‐cell lymphoma Umbralisib / Ukoniq / TG Therapeutics Kinase inhibitor for the treatment of relapsed or refractory 2/5/21 marginal zone lymphoma who have received one prior treatment with anti‐CD20‐based regimen and relapsed or refractory follicular lymphoma who received at least 3 prior systemic therapy Evinacumab‐dgnb / Evkeeza Regeneron Angiopoietin‐like 3 inhibitor indicated as adjunct to other 2/11/21 low‐density lipoprotein cholesterol lowering therapies in adults and pediatric patients 12 years and older with homozygous familial hypercholesterolemia (HoFH) Trilaciclib / Cosela / G1 Therapeutics Kinase inhibitor indicated to decrease incidence of 2/12/21 chemotherapy‐induced myelosuppression when administered prior to a platinum/etoposide‐containing regimen or topotecan‐containing regimen for extensive‐ stage small cell cancer Casimersen / Amondys 45 Sarepta Antisense oligonucleotide for the treatment of Duchenne 2/25/21 Therapeutics muscular dystrophy (DMD) in patients with confirmed mutation of the DMD gene amenable to exon 45 skipping Fosdenopterin / Nulibry / Origin To reduce the risk of death due to molybdenum cofactor 2/26/21 Biosciences deficiency type A, a rare genetic metabolic disorder FDA Activity Newsletter WSU Drug Information Center February 2021 Page | 3 New Indications: Description Date Approved Amantadine hydrochloride ER / Adjunctive treatment to levodopa/carbidopa in patients with 2/1/21 Gocovri / Adamas Pharmaceuticals Parkinson’s disease experiencing “off” episodes. Cemiplimab‐rwlc / Libtayo / Regeneron Locally advanced basal cell carcinoma or metastatic basal cell 2/9/21 carcinoma, previously treated with a hedgehog pathway inhibitor, or for whom a hedgehog pathway inhibitor is not appropriate OnabotulinumtoxinA / Botox / Allergan Treatment of pediatric neurogenic detrusor overactivity in 2/9/21 patients greater than 5 years of age, who are intolerant or have an inadequate response to anticholinergic medication. Bevacizumab‐bvzr / Zirabev / Pfizer Treatment of epithelial ovarian, fallopian tube, or primary 2/9/21 peritoneal cancer Immune globulin intravenous (human)‐ Treatment of adults with chronic inflammatory demyelinating 2/11/21 ifas 10% / Panzyga / Octapharma polyneuropathy to improve neuromuscular disability and impairment Cemiplimab‐rwlc / Libtayo / Regeneron First‐line therapy in patients with non‐small lung cell cancer 2/22/21 whose tumors have PD‐L1 expression ≥50% and disease is locally advanced where the patient is not a candidate for surgical resection or metastatic New Dosage Forms or Formulation: Description Date Approved Bupivacaine solution / Posimir / Durect Solution: 660 mg/5 mL; single‐dose administration into the 2/1/21 subacromial space under direct arthroscopic visualization to produce post‐surgical analgesia following arthroscopic subacromial decompression Compiled by: Terri Levien, Pharm.D. Drug Information Center Brittany Craft, Pharm.D., PGY2 Drug Information Resident College of Pharmacy and Pharmaceutical Sciences David Tam, Doctor of Pharmacy Candidate 2021 Washington State University Brandon Tabor, Doctor of Pharmacy Candidate 2021 412 E. Spokane Falls Blvd. Spokane, WA 99202‐2131 (509) 358‐7662 [email protected] FDA Activity Newsletter WSU Drug Information Center February 2021 Page | 4 Tepotinib / Tepmetko / EMD Serono, Inc. Generic Name / Brand Name / Company Tepotinib / Tepmetko / EMD Serono, Inc. Date of approval 2/3/21 Drug Class (Mechanism of Action if novel agent) Tepotinib is a kinase inhibitor that targets MET, including variants with exon 14 skipping alterations. Tepotinib inhibits hepatocyte growth factor (HGF)‐ dependent and ‐independent MET phosphorylation and MET‐dependent downstream signaling pathways. Tepotinib also inhibited melatonin 2 and imidazoline 1 receptors at clinically achievable concentrations. Indication Treatment of adult patients with metastatic non‐small cell lung cancer (NSCLC) harboring mesenchymal‐epithelial transition (MET) exon 14 skipping alterations. Comparative agent – Therapeutic interchange? Capmatinib Dosage forms/strengths. Tablet: 225 mg. Common Dose/sig Recommended dose: 450 mg taken orally once daily with food until disease progression or unacceptable toxicity DEA Schedule None Date of market availability Available Similar Medication Names Tepezza, Teprotumumab Clinical Use Evaluation Common Adverse Effects Adverse reactions (≥ 20%): Edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. The most common Grade 3 to 4 laboratory abnormalities (≥ 2%): Decreased lymphocytes, decreased albumin, decreased sodium, increased gamma‐glutamyl transferase,
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