FABHALTA Hard capsule Ref.[107283] Active ingredients: Iptacopan

2.1 Recommended Vaccination and Prophylaxis for Encapsulated Bacterial Infections

Vaccinate patients against encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis (serogroups A, C, W, Y and B), and Haemophilus influenzae type B, according to current ACIP recommendations at least 2 weeks prior to initiation of FABHALTA [see Warnings and Precautions (5.1)].

If urgent FABHALTA therapy is indicated in a patient who is not up to date with vaccines for Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible [see Warnings and Precautions (5.1)].

Healthcare providers who prescribe FABHALTA must enroll in the FABHALTA REMS [see Warnings and Precautions (5.2)].

2.2 Recommended Dosage

The recommended dosage of FABHALTA is 200 mg orally twice daily without regard to food.

Swallow capsules whole. Do not open, break, or chew capsules.

If a dose or doses are missed, advise the 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 schedule.

2.3 Patients Switching from Anti-C5 (eculizumab, ravulizumab) to FABHALTA

To reduce the potential risk of hemolysis with abrupt discontinuation of other PNH therapies:

• For patients switching from eculizumab, initiate FABHALTA no later than 1 week after the last dose of eculizumab.
• For patients switching from ravulizumab, initiate FABHALTA no later than 6 weeks after the last dose of ravulizumab.

There is no available information regarding the timeframe for initiation of FABHALTA after other PNH therapies.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].