For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment. For life-threatening infusion reactions, immediately and permanently stop OCREVUS and administer appropriate supportive treatment. The addition of an antipyretic (e.g., acetaminophen) may also be considered.
Administer pre-medication (e.g., methylprednisolone or an equivalent corticosteroid, and an antihistamine) to reduce the frequency and severity of infusion reactions. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Observe patients treated with OCREVUS for infusion reactions during the infusion and for at least one hour after completion of the infusion. There were no fatal infusion reactions, but 0.3% of OCREVUS-treated MS patients experienced infusion reactions that were serious, some requiring hospitalization.
In multiple sclerosis (MS) clinical trials, the incidence of infusion reactions in OCREVUS-treated patients was 34-40%, with the highest incidence with the first infusion. OCREVUS can cause infusion reactions, which can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis.
Warnings and Precautions Infusion Reactions OCREVUS is contraindicated in patients with active hepatitis B virus infection and in patients with a history of life-threatening infusion reaction to OCREVUS.
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