To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
PADCEV (ENFORTUMAB VEDOTIN-EJFV) - The Use in Specific Populations section of the Package Insert (PI) was updated to detail females of reproductive potential and the possibility to impair fertility. This was also included in the patient counseling information.
TYSABRI (NATALIZUMAB) - The Warnings and Precautions section of the PI was updated to include the need for prescribers to review, complete and sign the prescriber enrollment form to participate in the TOUCH® Prescribing Program. Details were also added for prescribers to complete a patient enrollment form for each patient. The medication guide was updated to detail that Tysabri is given by an infusion nurse from an infusion center that is enrolled in the TOUCH® Prescribing Program and each infusion will last about 1 hour.
POLVI (POLATUZUMAB VEDOTIN-PIIQ) - The Warnings and Precautions section of the PI was updated to detail clinical trial data for peripheral neuropathy, infusion-related reactions, myelosuppression, serious and opportunistic infections, progressive multifocal leukoencephalopathy, and hepatotoxicity. The Use in Specific Populations section was updated detailing use in females of reproductive potential, use in geriatric population and use in patients with hepatic impairment.
MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) - An additional Medication guide was created/added to the materials.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
This article contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with Coram.