To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
LUMIZYME (ALGLUCOSIDASE ALFA) The Boxed Warning section of the Approved Drug Label (ADL) as updated to include Hypersensitivity Reactions Including Anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate LUMIZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. These details were also updated throughout the Warnings and Precautions section. Additional Warnings and Precautions were included regarding the Risk of Developing Anti-alglucosidase Alfa Antibodies. Updates were made throughout the Use in Specific Populations sections including Pregnancy, Pediatric Use and Geriatric Use.
OMVOH (MIRIKIZUMAB-MRKZ) The Clinical Trials Experience section of the ADL was updated extensively. A newly added subsection in Drug Interactions was included to detail CYP450 Substrates. Upon initiation or discontinuation of OMVOH in patients treated with concomitant CYP450 substrates, monitor drug concentrations or other therapeutic parameters, and adjust the dosage of the CYP450 substrate as needed. The risk summary was updated regarding use in pregnancy. In Fetal/Neonatal Adverse Reactions, updates state that it is unclear whether mirikizumab-mrkz may interfere with an infant’s immune response to infections. Therefore, monitoring for the development of serious infection during the first 2 months of life in infants exposed in utero is recommended. Additional Clinical Trial Data was included regarding Animal Data and Data relating to Geriatric Use. Details were also included within the Medication Guide and Patient Counseling Information.
INJECTAFER (FERRIC CARBOXYMALTOSE) The Warnings and Precautions section of the ADL was updated regarding Symptomatic Hypophosphatemia, adding additional risk factors of malnutrition, and hereditary hemorrhagic telangiectasia (HHT or Osler-Weber-Rendu syndrome). Additional Clinical Trials Data was updated regarding Patients with Iron Deficiency and Heart Failure. The Pediatric Use section was updated stating that safety and effectiveness of Injectafer have not been established to improve exercise capacity in pediatric patients with ID and symptomatic heart failure. Details were also updated throughout the Patient Counseling Information.
CYCLOPHOSPHAMIDE The Contraindications section of the ADL was updated regarding Severe Hypersensitivity. Minor wording clarifications were made regarding Embryo-Fetal Toxicity. The Drug Interactions Section was updated to state that concomitant use of protease inhibitors may increase the concentration of cytotoxic metabolites and may enhance the toxicities of cyclophosphamide, including higher incidence of infections, neutropenia, and mucositis. Monitor for increased toxicities in patients receiving protease inhibitors. Drugs that Potentiate Cyclophosphamide Toxicities include patients receiving radiation therapy or drugs known to cause Myelosuppression and/or immunosuppression, Nephrotoxicity including hemorrhagic cystitis, Cardiotoxicity, Pulmonary toxicity, Secondary malignancies, and Hepatotoxicity including liver necrosis and VOD. Additional drug specific warnings were included for Metronidazole, Tamoxifen, Coumarins, and Cyclosporine. Details regarding Cardiotoxicity were included within the Patient Counseling Information.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
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