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.
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 6 weeks prior to initiation. Females of reproductive potential should use effective contraception during and for 6 months after last dose. Pregnancy. Nursing mothers.
Concomitant live or live-attenuated vaccines: not recommended during treatment and until B-cell repletion. Additive immunosuppressive effects with other immunosuppressants; consider the duration and effects when switching from immunomodulators (eg, corticosteroids, daclizumab, fingolimod, natalizumab, teriflunomide, mitoxantrone).
CD20-directed cytolytic monoclonal antibody.
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