Drug Information Center Highlights of FDA Activities – 1/1/21 – 1/31/21 FDA Drug Safety Communications & Drug Information Updates: Risk of False Results with the Curative SARS‐Cov‐2 Test for COVID‐19 1/7/2021 The Curative SARS‐Cov‐2 test is real‐time RT‐PCR test used to detect SARS‐Cov‐2. There are concerns that the test may yield false negatives. To reduce the risk of false negatives. Ensure that testing is done in accordance with the authorized labeling. Providers should consider retesting patients by using a different test if an inaccurate result is suspected. Health professionals and patients are encouraged to report problems with test performance or results to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Vinca Alkaloid Labeling for Preparation in Intravenous Infusion Bags Only 1/15/21 The FDA alerted health care professionals to labeling updates for the preparation of vinca alkaloids including vincristine sulfate injection, vinblastine sulfate for injection, and vinorelbine tartrate injection. To avoid unintended intrathecal administration, labeling is being updated to remove instructions for preparation of these products in a syringe and to recommend preparation in intravenous infusion bags only. Import Alert – All Alcohol‐Based Hand Sanitizers from Mexico 1/26/21 The FDA has placed all alcohol‐based hand sanitizers from Mexico on an import alert to prevent products contaminated with methanol from reaching the market. Inspections will determine if products have been manufactured according to U.S. current good manufacturing practice requirements before allowing entry. Misbranded Active Pharmaceutical Ingredients – Drug Information Update 1/28/21 The FDA issued a warning to Professional Compounding Centers of America (PCCA) for receiving and distributing misbranded active pharmaceutical ingredients. The FDA recommends customers of PCCA contact PCCA to verify the identity of original API manufacturers for products purchased through PCCA and to ensure the products they received met regulatory standards. Major Medication/Drug‐Related Product Recalls Announced Through MedWatch: Metformin HCl Extended‐Release Tablets USP, 750 mg, Nostrum Laboratories: Recall – NDMA 1/4/21 Nostrum Laboratories, Inc. recalled one lot (MET200501, exp. 7/22) of metformin HCl extended‐release tablets, USP 750 mg (NDC 29033‐056‐01, generic equivalent to Glucophage) due to levels of nitrosamine impurities (N‐ nitrosodimethylamine, NDMA) exceeding levels above the FDA authorized acceptable daily intake limit. Soho Fresh 70% Rubbing Alcohol, Essaar: Recall – Methanol Contamination 1/5/21 Essaar Inc. recalled one lot (#200528303) of Soho Fresh 70% Rubbing Alcohol in 33.81 oz due to contamination with methanol. Ketorolac Tromethamine Injection, USP, Fresenius Kabi: Recall – Particulate Matter 1/8/21 Fresenius Kabi USA recalled one lot of ketorolac tromethamine injection, USP, 30 mg/mL 1 mL fill in 2 mL amber vial (NDC 63323‐162‐01, product code 160201, batch 6121083, exp 2/21) due to the presence of particulate matter detected in a reserve sample. The recalled lot was distributed nationwide between 3/28/19 and 9/3/19. Cisatracurium Besylate Injection, USP, Meitheal Pharmaceuticals: Recall – Mislabeling 1/28/21 Meitheal Pharmaceuticals recalled one lot (C11507A, exp. October 2021) of cisatracurium besylate injection USP 10 mg/5 mL as a portion of the lot was mislabeled and contains cisatracurium besylate vials mis‐labeled as phenylephrine HCl injection 100 mg/10 mL. The cartons were distributed from 8/19/20 to 1/4/21. FDA Activity Newsletter WSU Drug Information Center January 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, tadalafil Adam’s Secret Extra Strength 3000 Platinum Sexual enhancement Sildenafil, tadalafil New Product Shortages No new shortages were reported by the FDA in January Brand Name or Sole Source Product Discontinuations/Withdrawals Date Posted Ursodiol capsules (Actigall, Allergan); generic formulations remain available 1/15/21 New Drug Approvals: Description (See Attached Drug Summaries) Date Approved Vericiguat / Verquvo / Merck & Co., Inc. Guanylate cyclase stimulator indicated to reduce the risk of 1/19/21 cardiovascular death and heart failure hospitalization in select patients with symptomatic chronic heart failure Cabotegravir / Vocabria / ViiV In combination with rilpivirine for the short‐term treatment 1/21/21 Healthcare of HIV‐1 infection in adults who are virologically suppressed on a stable antiretroviral regimen Cabotegravir and rilpivirine / Cabenuva / Integrase inhibitor and non‐nucleoside reverse transcriptase 1/21/21 ViiV Healthcare inhibitor for use as a complete regimen for the treatment of HIV‐1 infection to replace Voclosporin / Lupkynis / Aurinia Calcineurin‐inhibitor immunosuppressant for use in 1/22/21 Pharmaceuticals combination with a background immunosuppressive regimen for the treatment of active lupus nephritis New Indications: Description Date Approved Crizotinib / Xalkori / Pfizer Treatment of pediatric patients 1 year and older and young 1/14/21 adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is ALK‐positive Daratumumab and hyaluronidase‐fihj / Use in combination with bortezomib, thalidomide, and 1/11/21 Darzalex Faspro / Janssen Biotech Inc. dexamethasone in newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant Fam‐trastuzumab deruxtecan‐nxki / Treatment of adult patients with locally advanced or 1/15/21 Enhertu / Daiichi Sankyo, Inc. metastatic HER2‐positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab‐based regimen Levetiracetam tablets for oral Treatment of partial onset seizures in patients 4 years of age 1/19/21 suspension / Spritam / Aprecia and older weighing more than 20 kg. Pharmaceuticals LLC Carglumic acid / Carbaglu / Recordati Use as an adjunctive therapy to standard of care for the 1/22/21 Rare Diseases treatment of acute hyperammonemia due to propionic acidemia or methylmalonic acidemia Nivolumab / Opdivo / Bristol Myers Treatment of patients with advanced renal cell carcinoma, as 1/22/21 Squibb Company a first‐line treatment in combination with cabozantinib Cabozantinib / Cabometyx / Exelixis Inc. Treatment of patients with advanced renal cell carcinoma, as 1/22/21 a first‐line treatment in combination with nivolumab Romiplostim / Nplate / Amgen Inc. To increase survival in adults and pediatric patients acutely 1/28/21 exposed to myelosuppressive doses of radiation FDA Activity Newsletter WSU Drug Information Center January 2021 Page | 3 New Dosage Forms or Formulation: Description Date Approved Rilpivirine / Edurant / Janssen In combination with cabotegravir for the short‐term 1/21/21 treatment of HIV‐1 infection in adults who are virologically suppressed on a stable antiretroviral regimen Compiled by: Terri Levien, Pharm.D. Drug Information Center College of Pharmacy and Pharmaceutical Sciences Washington State University 412 E. Spokane Falls Blvd. Spokane, WA 99202‐2131 (509) 358‐7662 [email protected] FDA Activity Newsletter WSU Drug Information Center January 2021 Page | 4 Vericiguat / Verquvo / Merck & Co., Inc. Generic Name / Brand Name / Company Vericiguat / Verquvo / Merck & Co., Inc. Date of approval 1/19/21 Drug Class (Mechanism of Action if novel agent) Soluble guanylate cyclase stimulator; augments intracellular cGMP, leading to smooth muscle relaxation and vasodilation Indication To reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45% Comparative agent – Therapeutic interchange? Vasodilators such as isosorbide dinitrate/hydralazine Dosage forms/strengths. Tablets: 2.5 mg, 5 mg, 10 mg Common Dose/sig Starting dose: 2.5 mg orally once daily; double dose approximately every 2 weeks to reach target maintenance dose of 10 mg once daily, if tolerated DEA Schedule None Date of market availability Mid‐February 2021 Similar Medication Names None identified Clinical Use Evaluation Common Adverse Effects >5% hypotension, anemia Severe Adverse Effects None reported Severe Drug‐Drug Interactions PDE‐5 inhibitors: concomitant use is not recommended Other soluble guanylate cyclase stimulators: contraindicated Severe Drug‐Food Interactions None; recommended to be taken with food Important Labs Values to assess prior to order entry Obtain a pregnancy test in females of reproductive potential prior to or at point of clinical follow up. initiating therapy. Used in Pediatric Areas Safety and effectiveness have not been established Renal or Hepatic Dosing No dosage adjustment in patients with mild to moderate hepatic impairment or with estimated glomerular filtration rate (eGFR) > 15 mL/min/1.73 m2 who are not on dialysis. It has not been studied in patients with severe hepatic impairment, with eGFR < 15 mL/min/1.73 m2 or on dialysis. Critical Issues (i.e., contraindications, warnings, etc) Contraindicated with concomitant use of other soluble guanylate cyclase that should be emphasized stimulators (riociguat) and in pregnancy.