Uplizna

Monitor for infusion reactions during and ≥1hr after therapy completion; permanently discontinue if life-threatening infusion reactions occur; treat appropriately. Increased risk of infections. Assess for infections prior to every infusion; if active, delay Uplizna treatment until resolved. Risk of HBV reactivation. Perform HBV screening in all patients prior to initiation. Evaluate for TB risks and test/treat latent TB prior to initiation. Monitor levels of quantitative serum immunoglobulins before initiating, during and until B-cell repletion after discontinuation; consider discontinuing if low immunoglobulin G or M with a serious opportunistic infection or recurrent infections occur, or if prolonged hypogammaglobulinemia requires IV immunoglobulins. Withhold at first sign/symptom of progressive multifocal leukoencephalopathy (PML) and evaluate. Complete all immunizations according to guidelines ≥4 weeks prior to treatment. 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 of reproductive potential to use effective contraception during and for ≥6 months after the last dose. Pregnancy. Nursing mothers.