Systemic inj-related reactions generally occur w/in 24 hr & predominantly following the 1st inj. Potential for increased risk of infections. Evaluate patient's immune status prior to initiating therapy. Delay administration in patients w/ active infection until resolution. Risk of progressive multifocal leukoencephalopathy. Risk of hepatitis B reactivation. Patients w/ active hepatitis B disease should not be treated w/ Kesimpta. Perform HBV screening in all patients before treatment initiation. Administer all immunisations prior to treatment initiation at least 4 wk for live or live-attenuated vaccines & 2 wk for inactivated vaccines. May interfere w/ effectiveness of inactivated vaccines. Vaccination w/ live or live-attenuated vaccines is not recommended during treatment, & after discontinuation until B-cell repletion. Do not administer live or live-attenuated vaccines before recovery of B-cell counts has been confirmed in infants of mothers treated w/ Kesimpta during pregnancy. Women of childbearing potential should use effective contraception during treatment & for 6 mth after the last administration. Avoid use during pregnancy unless potential benefits outweigh potential risks. Use during lactation has not been studied; can be used during breast-feeding if clinically needed. Safety & efficacy in childn ≤18 yr have not yet been established.
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