May predispose individuals to serious, life-threatening or fatal infections caused by encapsulated bacteria. Vaccinate against encapsulated bacteria, including
Neisseria meningitidis &
Strep pneumoniae, to reduce risk of infection. Vaccinate against HIB if vaccine is available. Administer vaccines at least 2 wk prior to administration of the 1st dose of iptacopan. Vaccinate as soon as possible if iptacopan must be initiated prior to vaccination & provide w/ antibacterial prophylaxis until 2 wk after vaccine administration. Adhere to dosing schedule to minimise risk of haemolysis. Regularly monitor for signs & symptoms of haemolysis, including measuring LDH levels. Closely monitor for signs & symptoms of haemolysis for at least 2 wk after the last dose if treatment must be discontinued. Consider restarting treatment if haemolysis occurs after discontinuation. Concomitant use w/ strong inducers of CYP2C8, UGT1A1, PgP, BCRP & OATP1B1/3 is not recommended. Initiate iptacopan no later than 1 wk after the last dose of eculizumab for patients switching from eculizumab. Initiate iptacopan no later than 6 wk after the last dose of ravulizumab for patients switching from ravulizumab. Switches from complement inhibitors other than eculizumab & ravulizumab have not been studied. No dose adjustment is required in patients w/ mild or moderate renal impairment. No data are currently available in patients w/ severe renal impairment or on dialysis. Not recommended in patients w/ severe hepatic impairment (Child-Pugh class C). Use in pregnant women or women planning to become pregnant may only be considered following careful assessment of risk & benefits, if necessary. Discontinue breast-feeding or discontinue/abstain from Fabhalta therapy. Safety & efficacy in childn <18 yr have not been established.
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