VOYDEYA Film-coated tablet Ref.[110089] Active ingredients: Danicopan

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), 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 danicopan in patients ≥65 years of age is limited (see section 5.1).

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).

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). Studies have not been conducted in patients with severe (Child-Pugh Class C) hepatic impairment. Therefore, danicopan is not recommended in this patient population (see section 4.4).

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).

Single doses up to 1 200 mg and multiple doses up to 800 mg twice a day have been taken in healthy volunteers. ALT elevations occurred after treatment cessation without a taper in 2 subjects who received 500 mg and 800 mg twice a day for 14 days. All abnormal ALT findings were transient, with no evidence of hepatic function abnormality and resolved spontaneously.

In case of overdose, elevations in aminotransferase and other liver parameters may occur. General supportive measures are recommended. It is not known whether danicopan can be removed by dialysis.

30 months in high-density polyethylene (HDPE) bottle.

After first opening the bottle: 48 days.

2 years in polyvinyl chloride (PVC)/polychlorotrifluoroethylene (PCTFE) / PVC blisters.

This medicinal product does not require any special storage conditions.

Bottle

HDPE bottles containing 90 film-coated tablets with desiccant and child resistant seal. Each pack contains 180 film-coated tablets.

The following pack sizes are available:

• Packs containing 1 bottle of 90 × 50 mg film-coated tablets and 1 bottle of 90 × 100 mg film-coated tablets.
• Packs containing 2 bottles of 90 × 100 mg film-coated tablets.

Blister

PVC/PCTFE/PVC blister. Each pack contains 168 film-coated tablets.

The following pack sizes are available:

• Pack containing 4 blister wallet cards (child resistant), each containing 21 × 50 mg film-coated tablets and 21 × 100 mg film-coated tablets.
• Pack containing 4 blister wallet cards (child resistant), each containing 42 × 100 mg film-coated tablets.

Not all pack sizes may be marketed.

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