Basic Information
VOLIBRIS FILM-COATED TABLET 10 MG
TABLET, FILM COATED
Regulatory Information
SIN15094P
September 30, 2016
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XC02KX02
Company Information
Active Ingredients
Strength: 10.0 mg
Detailed Information
Contraindications
**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.
Indication Information
**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.