FABHALTA^® (iptacopan) is a single capsule taken orally twice a day¹

• FABHALTA can be taken without regard to food. Patients should swallow capsules whole. Instruct patients to not open, break, or chew capsules¹

• If a dose or doses are missed, advise your patient to take one dose of FABHALTA as soon as possible (even if it is soon before the next scheduled dose) and then to resume the regular dosing schedule¹

• Concomitant use of CYP2C8 inducers (eg, rifampin) may decrease FABHALTA exposure, which may result in loss of or reduced efficacy of FABHALTA. Monitor the clinical response and discontinue use of CYP2C8 inducer if loss of efficacy of FABHALTA is evident¹

• Concomitant use of strong CYP2C8 inhibitors (eg, gemfibrozil) may increase FABHALTA exposure, which may result in an increased risk for adverse reactions with FABHALTA. Coadministration with a strong CYP2C8 inhibitor is not recommended¹

Those who are breastfeeding¹:

• Because of the potential for serious adverse reactions in a breastfed child, breastfeeding should be discontinued during treatment with FABHALTA and for 5 days after the final dose

Those with hepatic impairment¹:

• FABHALTA is not recommended in patients with severe hepatic impairment (Child-Pugh class C). No dose adjustment is required for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment

RECOMMENDED VACCINATION AND PROPHYLAXIS FOR ENCAPSULATED BACTERIAL INFECTIONS¹

• Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis (serogroups A, C, W, Y and B), according to current ACIP recommendations at least 2 weeks prior to starting FABHALTA

• If urgent FABHALTA therapy is indicated in a patient who is not up to date with vaccines for Streptococcus pneumoniae and Neisseria meningitidis according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible

• Healthcare providers who prescribe FABHALTA must enroll in the FABHALTA REMS. See Getting Started for more information

To prescribe FABHALTA, you will need to enroll in the FABHALTA REMS   Visit the Getting Started page for more information.