Fabhalta Dosage/Direction for Use

Posology: The recommended dose is 200 mg taken orally twice daily.
Healthcare professionals should advise patients with PNH about the importance of adherence to the dosing schedule in order to minimise the risk of haemolysis (see Precautions).
If a dose or doses are missed, the patient should be advised to take one dose as soon as possible (even if it is shortly before the next scheduled dose) and then to resume the regular dosing schedule. Patients with several consecutive missed doses should be monitored for potential signs and symptoms of haemolysis.
PNH is a disease that requires chronic treatment. Discontinuation of this medicinal product is not recommended unless clinically indicated (see Precautions).
Patients switching from anti-C5 (eculizumab, ravulizumab) or other PNH therapies to iptacopan: To reduce the potential risk of haemolysis with abrupt treatment discontinuation: For patients switching from eculizumab, iptacopan should be initiated no later than 1 week after the last dose of eculizumab.
For patients switching from ravulizumab, iptacopan should be initiated no later than 6 weeks after the last dose of ravulizumab.
Switches from complement inhibitors other than eculizumab and ravulizumab have not been studied.
Special populations: Elderly: No dose adjustment is required for patients 65 years of age and older (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required in patients with mild (estimated glomerular filtration rate [eGFR] between 60 and <90 ml/min) or moderate (eGFR between 30 and <60 ml/min) renal impairment. No data are currently available in patients with severe renal impairment or on dialysis and no dose recommendations can be given (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The use of iptacopan 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 (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of iptacopan in children aged below 18 years have not been established. No data are available.
Method of administration: For oral use.
This medicinal product may be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).