FABHALTA CAPSULE 200MG [SIN17304P]

Product Info

FABHALTA CAPSULE 200MG

[SIN17304P]

Indication

3 Indications

Fabhalta is indicated as monotherapy for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have haemolytic anaemia.

Dosing

4 Dosage regimen and administration

Dosage regimen

The recommended dose is 200 mg taken orally twice daily.

If a dose or doses are missed, the patient should be advised 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. Patients with PNH who have missed several consecutive 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 6 Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients switching from anti-C5 (eculizumab, ravulizumab) to Fabhalta

To reduce the potential risk of hemolysis with abrupt treatment discontinuation:

• For patients switching from eculizumab, Fabhalta should be initiated no later than 1 week after the last dose of eculizumab.

• For patients switching from ravulizumab, Fabhalta 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.

Adherence to dosing schedule

Healthcare providers should advise patients with PNH about the importance of adherence to the dosing schedule in order to minimize the risk of hemolysis (see section 6 Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

Renal impairment

No dose adjustment is required in patients with mild (estimated glomerular filtration rate [eGFR] 60– <90 mL/min/1.73 m²) or moderate (eGFR 30– <60 mL/min/1.73 m²) 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 11 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is required for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B). The use of iptacopan is not recommended in patients with severe hepatic impairment (Child-Pugh class C) (see section 11 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information),

Pediatric patients

The safety and efficacy of Fabhalta in patients below the age of 18 years have not been established.

Geriatric patients (65 years of age or above)

No dose adjustment is required for patients aged 65 years and over (see section 11 Clinical Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

For oral use. Fabhalta may be taken with or without food (see section 11 Clinical pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

5 Contraindications

Fabhalta is contraindicated:

• in patients with hypersensitivity to iptacopan or to any of the other excipients.

• in patients who are not currently vaccinated against Neisseria meningitidis and Streptococcus pneumoniae unless the risk of delaying Fabhalta treatment outweighs the risk of developing an infection from these encapsulated bacteria (see section 6 Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• for initiation in patients with unresolved serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B.