OCREVUS Rx

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OCREVUS

Multiple sclerosis
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Generic Name and Formulations:

Ocrelizumab 30mg/mL; soln for IV infusion after dilution; preservative-free.

Company:

Genentech, Inc.

Select therapeutic use:

Indications for OCREVUS:

Relapsing or primary progressive forms of multiple sclerosis.

Adult:

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.

Children:

Not established.

Contraindications:

Active HBV infection.

Warnings/Precautions:

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.

Interactions:

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).

Pharmacological Class:

CD20-directed cytolytic monoclonal antibody.

Adverse Reactions:

Upper/lower respiratory tract infections, infusion reactions (eg, pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, others), skin infections; herpes virus-associated infections.

Generic Availability:

NO

How Supplied:

Single-dose vial (10mL)—1

OCREVUS 10ml of 30mg/ml vials (Qty:2)

appx. price $33550.00