Generic Name and Formulations:
Ocrelizumab 30mg/mL; soln for IV infusion after dilution; preservative-free.
Indications for OCREVUS:
Relapsing or primary progressive forms of multiple sclerosis.
Screen for HBV infection prior to initiation. Premedicate with corticosteroid and antihistamine prior to each infusion; may consider antipyretic. Initially 300mg by IV infusion, followed by a second 300mg infusion 2 weeks later, then subsequently as one 600mg infusion every 6 months. For infusion rates, duration, and dose modifications: see full labeling.
Active HBV infection. History of life-threatening infusion reaction to Ocrevus.
Monitor for infusion reactions during therapy and at least 1hr after completion; permanently discontinue if life-threatening infusion reactions occur; treat appropriately. Active infection; delay Ocrevus treatment until resolved. Withhold at first sign/symptom of progressive multifocal leukoencephalopathy (PML) and evaluate. HBV reactivation: test all patients for HBV; if positive HBsAg/anti-HB results, do not administer Ocrevus. Increased risk of malignancy (including breast cancer). Complete all immunizations according to guidelines at least 4 weeks (for live or live-attenuated vaccines) or at least 2 weeks (for non-live vaccines) prior to initiation. Infants born to mothers treated during pregnancy: do not administer live or live-attenuated vaccines before confirming B-cell recovery; non-live vaccines may be given prior to recovery, but should consider assessment of vaccine immune response. Females of reproductive potential should use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers.
CD20-directed cytolytic monoclonal antibody.
Concomitant live or live-attenuated vaccines: not recommended during treatment and until B-cell repletion. May interfere with the effectiveness of non-live vaccines. Additive immunosuppressive effects with other immunosuppressants; consider the duration and effects when switching from immunomodulators (eg, corticosteroids, daclizumab, fingolimod, natalizumab, teriflunomide, mitoxantrone).
Upper/lower respiratory tract infections, infusion reactions (eg, pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, others), skin infections; herpes virus-associated infections.
Single-dose vial (10mL)—1
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