CYCLOPHOSPHAMIDE The Adverse Reactions section of the Package Insert (PI) was updated to detail neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea as the most common adverse reactions. Additional guidance was added due to the potential to cause fetal harm when administered to a pregnant woman.
RENFLEXIS (INFLIXIMAB-ABDA) The Contraindications section of the PI was updated to state the medication is contraindicated at doses >5 mg/kg in patients with moderate or severe heart failure and patients with a previous severe hypersensitivity reaction to infliximab products. The medication guide was also updated to state that it is not known if the medication is safe and effective in children under 6 years of age.
MANGANESE CHLORIDE IN PLASTIC CONTAINER (MANGANESE CHLORIDE) The Warnings and Precautions section of the PI was updated to detail neurologic toxicity due to manganese accumulation in the basal ganglia and hepatic accumulation in adult and pediatric patients.
XENPOZYME (OLIPUDASE ALFA-RPCP) The Warnings and Precautions section of the PI as well as the Patient Counseling Information was updated to detail Hypersensitivity Reactions (Including Anaphylaxis) and Infusion-Associated Reactions (IARs). Recommendations were added to consider pre-medicating with antihistamines, antipyretics, and/or corticosteroids to reduce the risk of infusion-associated reactions. IARs may still occur in patients after receiving pre-treatment. Additional guidance was outlined specifying the dose escalation regimen to minimize IARs.
KEYTRUDA (PEMBROLIZUMAB) The Clinical Trials Experience section of the PI was updated to detail data from the study KEYNOTE-A39 regarding use in patients with urothelial cancer in combination with enfortumab vedotin. The included data detailes serious adverse reactions, dose interruptions, permanent discontinuation and fatal adverse reactions.
SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE)
DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE)
The Warnings and Precautions section of the PIs for each Corticosteroid listed above was updated to detail tumor lysis syndrome (TLS) in post marketing experience in patients with malignancies. Patients at high risk of TLS, such as patients with tumors that have a high proliferative rate, high tumor burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
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