Briumvi Generic Name & Formulations
Single-dose vial (6mL)—1
Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Briumvi Dosage and Administration
Premedicate with corticosteroid (eg, methylprednisolone IV or oral equivalent) approx. 30mins and antihistamine (eg, diphenhydramine oral or IV) approx. 30–60mins prior to each infusion; also may consider an antipyretic (eg, APAP). Give by IV infusion. First infusion: Initially 150mg. Second infusion: 450mg given 2 weeks after the first infusion. Subsequent infusions: 450mg given 24 weeks after the first infusion and then every 24 weeks thereafter. For infusion rates, duration, and dose modifications: see full labeling.
Active HBV infection. History of life-threatening infusion reaction to Briumvi.
Briumvi Boxed Warnings
Administer under the supervision of an experienced healthcare provider. Have appropriate medical support available. Monitor for infusion reactions during and at least 1hr after completion of the first 2 infusions; permanently discontinue if life-threatening infusion reactions occur; treat appropriately. Increased risk of infections. Delay Briumvi in those with active infection until resolved. Risk of HBV reactivation. Perform HBV screening in all patients prior to initiation. Withhold at first sign/symptom of progressive multifocal leukoencephalopathy (PML) and evaluate; discontinue if confirmed. Monitor levels of quantitative serum immunoglobulins before initiating, during and after discontinuation until B-cell repletion; consider discontinuing if low immunoglobulins with a serious opportunistic infection or recurrent infections occur, or if prolonged hypogammaglobulinemia requires IV immunoglobulins. Complete all immunizations according to guidelines ≥4 weeks for live or live-attenuated vaccines, and if possible, ≥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. Advise females or reproductive potential to use effective contraception during and ≥6 months after the last dose. Pregnancy: exclude status prior to each infusion. Nursing mothers.
Half-life: 22 days.
Concomitant live or live-attenuated vaccines: not recommended during treatment and after discontinuation until B-cell repletion. May interfere with the effectiveness of non-live vaccines. Potential additive immunosuppressive effects with other immunosuppressants including systemic corticosteroids.
Briumvi Adverse Reactions
Infusion reactions, upper respiratory tract infections, lower respiratory tract infections, herpes virus-associated infections, pain in extremity, insomnia, fatigue.
Briumvi Clinical Trials
Briumvi Patient Counseling