FABHALTA Hard capsule Ref.[110453] Active ingredients: Iptacopan

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 section 4.4).

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 section 4.4).

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 section 5.2).

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 section 5.2).

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 section 5.2).

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 section 5.2).

During clinical studies, a few patients took up to 800 mg iptacopan daily and this was well tolerated. In healthy volunteers, the highest dose was 1 200 mg administered as a single dose and this was well tolerated.

General supportive measures and symptomatic treatment should be initiated in cases of suspected overdose.

2 years.

This medicinal product does not require any special storage conditions.

FABHALTA is supplied in PVC/PE/PVDC blisters with aluminium foil backing.

Packs containing 28 or 56 hard capsules.

Multipacks containing 168 (3 packs of 56) hard capsules.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.