AVYCAZ (AVIBACTAM SODIUM; CEFTAZIDIME) The Approved Drug Label was updated to detail altered laboratory tests in clinical trials. Additional adverse reaction details were added to include nervous system disorders and hypersensitivity reactions. Pediatric trial data was included as well as details for safety and efficacy in pediatric patients at least 31 weeks gestational age and older.
CEFAZOLIN IN PLASTIC CONTAINER (CEFAZOLIN SODIUM) The Approved Drug Label was updated to detail alterations in prothrombin activity. The Clinical Trials Experience and Pediatric Use sections were updated to detail clinical trial data, adverse reactions, and safety and efficacy when used in Pediatric Patients for Perioperative Prophylaxis.
DIFLUCAN (FLUCONAZOLE) The Approved Drug Label was updated to detail clinical trial experience when used for Invasive Candida Infections in premature infants weighing less than 750 grams at birth and in pediatric patients receiving extracorporeal membrane oxygenation.
HEPARIN SODIUM IN DEXTROSE 5% IN PLASTIC CONTAINER The Contraindications section of the Approved Drug Label was updated to detail coagulation interval testing requirements and added contraindication of patients with an uncontrollable active bleeding state. The Fatal Medication Errors section was updated not to use high dose product as a “catheter lock flush”. The Warnings and Precautions were updated throughout, adding details regarding Hemorrhage, Heparin-Induced Thrombocytopenia (HIT) and Heparin-Induced Thrombocytopenia and Thrombosis (HITT), Thrombocytopenia, Coagulation Testing and Monitoring, Heparin Resistance, Hypersensitivity Reactions, Hyperkalemia, and Elevations of Serum Aminotransferases. The Drug Interaction section was updated to include intravenous nitroglycerin. Use in Specific Populations was also updated to detail risk in Pregnancy and Lactation as well as Pediatric and Geriatric Use.
OCREVUS (OCRELIZUMAB) The Warnings and Precautions section of the Approved Drug Label was updated to detail the increased risk of infections (including serious and fatal bacterial, fungal, and new or reactivated viral infections) observed in patients during and following completion of treatment.
BLINCYTO (BLINATUMOMAB) The BOXED WARNING section of the Approved Drug Label was updated to detail Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). These details were also added to Warnings and Precautions, Adverse Reactions and Patient Counseling sections.
PROLIA (DENOSUMAB) The Approved Drug Label was updated throughout including the BOXED WARNING section detailing Severe Hypocalcemia in patients with advanced kidney disease.
FABRAZYME (AGALSIDASE BETA) The Warnings and Precautions section of the Approved Drug Label was updated to include life-threatening hypersensitivity reactions, including anaphylaxis.
SOLIRIS (ECULIZUMAB) The BOXED WARNING section of the Approved Drug Label was updated stating the medication increases the risk of serious infections caused by Neisseria meningitidis which can become life-threatening and fatal if not recognized and treated early. Soliris REMS program was detailed, and inclusion of this information was carried throughout numerous sections.
ULTOMIRIS (RAVULIZUMAB-CWVZ) The BOXED WARNING section of the Approved Drug Label was updated stating the medication increases the risk of serious infections caused by Neisseria meningitidis which can become life-threatening and fatal if not recognized and treated early. Soliris REMS program was detailed, and inclusion of this information was carried throughout numerous sections.
BENLYSTA (BELIMUMAB) The Warnings and Precautions section of the Approved Drug Label was updated to detail use and/or discontinuation in patients with Progressive Multifocal Leukoencephalopathy.
PULMOZYME (DORNASE ALFA) The Patient Counseling Information was updated advising patients to read the FDA-approved patient labeling (Instructions for Use) and referencing Approved Drug Labeling sections.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
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