OPSUMIT FILM-COATED TABLET 10MG [SIN14809P]

Product Info

OPSUMIT FILM-COATED TABLET 10MG

[SIN14809P]

INDICATIONS AND CLINICAL USE

OPSUMIT® (macitentan) is indicated for the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group l) to reduce morbidity in patients of WHO Functional Class II or III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or corrected simple congenital heart disease.

OPSUMIT® is effective when used as monotherapy or in combination with phosphodiesterase-5 inhibitors.

Geriatrics (≥ 65 years of age): Of the total number of subjects in the clinical study of OPSUMIT® for PAH, 14% were ≥65 years of age.

Pediatrics (<18 years of age): The safety and efficacy of OPSUMIT® in children and adolescents <18 years of age has not yet been established.

DOSAGE AND ADMINISTRATION

Recommended Dose and Dosage Adjustment

The recommended dose of OPSUMIT® is 10 mg once daily.

Patients with Hepatic Impairment

There is no clinical experience with the use of OPSUMIT® in PAH patients with moderate or severe hepatic impairment. Therefore, use of OPSUMIT® in this patient population is not recommended (see Warnings and Precautions, Hepatic/Biliary/Pancreatic – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No dose adjustment is required in patients with mild hepatic impairment.

Patients with Renal Impairment

Patients with moderate or severe renal impairment may run a higher risk of experiencing hypotension and anemia during treatment with macitentan. Therefore monitoring of blood pressure and hemoglobin should be considered. There is no experience with the use of OPSUMIT® in patients undergoing dialysis, and therefore OPSUMIT® is not recommended in this population (see Warnings and Precautions, Renal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Geriatrics

No dose adjustment is required in patients ≥65 years of age.

There is limited clinical experience in patients >75 years of age, and therefore macitentan should be used with caution in this population (see Warnings and Precautions, Special Populations, Geriatrics (≥65 years of age) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatrics (<18 years of age)

The safety and efficacy of OPSUMIT® in children and adolescents <18 years of age have not yet been established.

Missed Dose

If a dose of OPSUMIT® is missed, the tablet should be taken as soon as it is remembered.

Administration

OPSUMIT® is to be taken orally at a dose of 10 mg once daily, with or without food. The film-coated tablets must be swallowed whole, with water, and must not be chewed, divided or crushed.

CONTRAINDICATIONS

OPSUMIT® (macitentan) is contraindicated in:

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the Product Monograph – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Women who are or may become pregnant. (see Warnings and Precautions, Special Populations, Pregnant Women – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• Nursing women (see Warnings and Precautions, Special Populations, Nursing Women – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).