VOLIBRIS FILM-COATED TABLET 10 MG [SIN15094P]

Product Info

VOLIBRIS FILM-COATED TABLET 10 MG

[SIN15094P]

3. THERAPEUTIC INDICATIONS

VOLIBRIS is indicated for treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 12.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.

4. POSOLOGY AND METHOD OF ADMINISTRATION

4.1. General
Ambrisentan is for oral use and can be administered with or without food. Treatment should only be initiated by a physician experienced in the treatment of PAH.

4.2. Recommended adult dosage
Ambrisentan treatment should be initiated at a dose of 5 mg once daily and may be increased to 10 mg once daily depending upon clinical response and tolerability.

When used in combination with tadalafil, the ambrisentan starting dose of 5 mg should be titrated to 10 mg once daily, as tolerated (see section 12.1.2.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Limited data suggest that the abrupt discontinuation of ambrisentan is not associated with rebound worsening of PAH.

4.3. Use with cyclosporine A
When co-administered with cyclosporine A, the dose of ambrisentan should be limited to 5 mg once daily and the patient should be carefully monitored (see Interactions with Other Medicinal Products and Other Forms of Interaction; Pharmacokinetic Properties, Metabolism – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.4. Recommended pediatric and adolescent dosage
Safety and efficacy of ambrisentan have not been established in patients under 18 years of age; therefore, the use of ambrisentan in these patients is not recommended (see Non-clinical Information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.5. Dosage instructions in special populations

4.5.1. Elderly
No dose adjustment is required in patients aged 65 years and over (see Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.5.2. Renal Impairment
No dose adjustment is required in patients with renal impairment (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). There is limited experience of VOLIBRIS in individuals with severe renal impairment (creatinine clearance <30 mL/min); initiate treatment cautiously in this subgroup and take particular care if the dose is increased to 10 mg.

4.5.3. Hepatic Impairment
VOLIBRIS has not been studied in individuals with severe hepatic impairment or with clinically significant elevated hepatic transaminases. Since the main routes of metabolism of ambrisentan are glucuronidation and oxidation with subsequent elimination in the bile, hepatic impairment would be expected to increase exposure (C_max and AUC) of ambrisentan. Therefore, VOLIBRIS is not recommended in patients with moderate impairment, is contraindicated in patients with severe hepatic impairment (with or without cirrhosis) or with clinically significant elevated hepatic transaminases (see Contraindications, Special Warnings and Special Precautions for Use and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Use caution when administering VOLIBRIS in patients with mild pre-existing impaired liver function who may require reduced doses of VOLIBRIS (see Special Warnings and Special Precautions for Use and Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.6. Method of Administration
It is recommended that the tablet is swallowed whole and it can be taken with or without food. It is recommended that the tablet should not be split, crushed or chewed.

5. CONTRAINDICATIONS

Ambrisentan is contraindicated in pregnancy (see Pregnancy and Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Ambrisentan is contraindicated in women of child-bearing potential who are not using reliable contraception (see Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Women must not become pregnant for at least 3 months after stopping treatment with ambrisentan.

Ambrisentan is contraindicated in patients with severe hepatic impairment (with or without cirrhosis) (see Special Warnings and Special Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Ambrisentan is contraindicated in patients with baseline values of hepatic aminotransferases (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) greater than 3 times the Upper Limit of Normal (ULN) (see Special Warnings and Special Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Ambrisentan is contraindicated in idiopathic pulmonary fibrosis (IPF) with or without secondary pulmonary hypertension.

Ambrisentan is contraindicated in patients who exhibit or may exhibit hypersensitivity to ambrisentan or to any of the other excipients.

Ambrisentan is contraindicated in breast-feeding.