JERAYGO Film-coated tablet Ref.[111534] Active ingredients: Aprocitentan

Posology

The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control (see section 4.4).

Missed dose

If the patient misses a dose, the patient should be told to resume treatment the next day and not take two doses in the same day.

Special populations

Elderly

No dose adjustment is required in patients over the age of 65 years (see section 5.2). There is limited clinical experience in patients over the age of 75 years (see section 4.4).

Renal impairment

No dose adjustment is required in patients with renal impairment (including severe impairment with estimated glomerular filtration rate [eGFR] 15–29 mL/min) (see sections 4.4 and 5.2).

Aprocitentan has not been studied in patients with eGFR <15 mL/min or in patients undergoing dialysis; JERAYGO is not recommended in these patients (see section 4.4).

Hepatic impairment

No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh class A or B, respectively) (see section 5.2).

Aprocitentan has not been studied in patients with severe hepatic impairment (Child-Pugh class C); JERAYGO must not be initiated in these patients (see sections 4.3 and 4.4).

Paediatric population

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

Method of administration

Oral use.

JERAYGO may be taken with or without meals (see section 5.2).

The film-coated tablets are not scored and are designed to be swallowed whole.

Aprocitentan has been administered as a single dose of up to 600 mg, and as multiple doses of up to 100 mg daily to healthy subjects (24 and 4 times the maximum approved dose, respectively).

Adverse reactions of headache, nasal congestion, nausea and upper respiratory tract infection were observed.

In the event of an overdose, standard supportive measures should be taken, as required. Because of possible QT interval prolongation at very high concentrations (i.e., more than 22 tablets of aprocitentan 12.5 mg), ECG monitoring should be considered. Dialysis is unlikely to be effective because aprocitentan is highly protein-bound (see section 5.2).

30 months.

Store in the original package (HDPE bottle or blisters) in order to protect from moisture (no special temperature storage conditions are required).

Keep the HDPE bottles tightly closed in order to protect from moisture.

JERAYGO 12.5 mg film-coated tablets:

White, opaque, HDPE bottle with child-resistant closure and induction seal liner, containing silica gel desiccant and 30 film-coated tablets.

Perforated unit dose blisters in aluminium cold-form film with desiccant and aluminium push-through lidding foil containing 10 × 1 film-coated tablets.

JERAYGO 25 mg film-coated tablets:

White, opaque, HDPE bottle with child-resistant closure and induction seal liner, containing silica gel desiccant and 30 film-coated tablets.

Perforated unit dose blisters in aluminium cold-form film with desiccant and aluminium push-through lidding foil containing 10 × 1 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.