Briumvi

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.