VOYDEYA FILM-COATED TABLET 100 MG + 100 MG [SIN17151P]

Product Info

VOYDEYA FILM-COATED TABLET 100 MG + 100 MG

[SIN17151P]

4.1 Therapeutic indications

VOYDEYA is indicated as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Treatment should be initiated by a healthcare professional experienced in the management of patients with haematological disorders.

Posology

The recommended starting dose is 150 mg three times a day administered orally, approximately 8 hours apart (± 2 hours). Dose can be increased to 200 mg three times a day after a minimum of 4 weeks of treatment depending on clinical response.

Missed doses

If a dose is missed, patients should be advised to take it as soon as it is remembered unless it is almost time for the next dose in which case patients should skip the missed dose and take the medicinal product at the next regularly scheduled time. Patients should be advised not to take 2 doses or more at the same time.

Discontinuation

Due to the possibility of alanine aminotransferase (ALT) elevations after treatment cessation (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), if treatment is discontinued, the dose should be tapered over a 6-day period until complete cessation, as follows:

• 100 mg regimen: 100 mg twice a day for 3 days, followed by 100 mg once a day for 3 days.

• 150 mg regimen: 100 mg three times a day for 3 days, followed by 50 mg three times a day for 3 days.

• 200 mg regimen: 100 mg three times a day for 3 days, followed by 100 mg twice a day for 3 days.

Special populations

Elderly

No dose adjustment is required in elderly patients. However, experience with VOYDEYA in patients ≥ 65 years of age is limited (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No dose adjustment is required in patients with mild (estimated glomerular filtration rate [eGFR] ≥ 60 to < 90 mL/min/1.73 m²) or moderate (eGFR ≥ 30 to < 60 mL/min/1.73 m²) renal impairment. In patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²), the recommended starting dose is 100 mg three times a day administered orally, approximately 8 hours apart (± 2 hours). Dose can be increased to 150 mg three times a day after a minimum of 4 weeks of treatment depending on clinical response (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

No dose adjustment is required in patients with mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Studies have not been conducted in patients with severe (Child-Pugh Class C) hepatic impairment. Therefore, VOYDEYA is not recommended in this patient population (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

The safety and efficacy of VOYDEYA in children aged less than 18 years have not yet been established. No data are available.

Method of administration

Oral use.

Tablets should be taken with food (meal or snack) (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Patients with unresolved Neisseria meningitidis infection at treatment initiation (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Patients who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).