ENTYVIO PEN (VEDOLIZUMAB) The Medication Guide and Instructions For Use were updated for subcutaneous administration via the Entyvio Pen.
SPEVIGO (SPESOLIMAB-SBZO) The Contraindications section of the Approved Drug Label was updated to include hypersensitivity reactions. The Infections section was updated stating if a patient develops a clinically important active infection, discontinue SPEVIGO therapy until the infection resolves or is adequately treated. Additional guidance was provided stating all age-appropriate vaccinations should be completed before initiating SPEVIGO for Generalized Pustular Psoriasis (GPP). Study data was included to support the safety and effectiveness of SPEVIGO for the treatment of GPP in pediatric patients 12 years of age and older and weighing at least 40 kg.
DANYELZA (NAXITAMAB-GQGK) The Warnings and Precautions section of the Approved Drug Label was updated to state that caution is advised in patients with pre-existing cardiac disease, as the medication may exacerbate the risk of severe hypotension. New subsections were included detailing Myocarditis, Orthostatic Hypotension, and Embryo-Fetal Toxicity. Females of reproductive potential shall be advised to use effective contraception during treatment and for 2 months after the last dose of DANYELZA.
SOLIRIS (ECULIZUMAB) Updates were made throughout the Approved Drug Label and Patient Counseling Information to detail that SOLIRIS is available only through a restricted program called ULTOMIRIS and SOLIRIS REMS.
ULTOMIRIS (RAVULIZUMAB-CWVZ) The Warnings and Precautions section of the Approved Drug Label was updated in the subsection Infusion-Related Reactions to include abdominal pain, muscle spasms and rigors. Clinical Trial Experience was included when used in adults with Neuromyelitis Optica Spectrum Disorder (NMOSD). The Medication Guide was updated to detail the most common side effects when administered in patients with NMSOD to be COVID-19 infection, urinary tract infection, headache, joint pain (arthralgia), and back pain.
KESIMPTA (OFATUMUMAB) The Warnings and Precautions and Contraindications sections of the Approved Drug Label were updated stating KESIMPTA can result in systemic injection-related reactions and hypersensitivity reactions, which may be serious or life-threatening. A new subsection was added detailing Pregnancy Exposure Registry for monitoring pregnancy outcomes in women exposed to KESIMPTA during pregnancy.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
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