Dear Healthcare Professional Letter on contraindications regarding the use of Volibris (ambrisentan) in patients with Idiopathic Pulmonary Fibrosis (IPF)
GlaxoSmithKline d.o.o., in consultation with the Agency for Medicinal Products (HALMED), has sent a letter to healthcare professionals on contraindications regarding the use of Volibris (ambrisentan) in patients with Idiopathic Pulmonary Fibrosis (IPF).
- Ambrisentan should not be used in patients with Idiopathic Pulmonary Fibrosis (IPF).
- In clinical study of IPF patients higher hospitalisation rates were reported due to respiratory problems, higher death rates and higher rates of decreases in respiratory function in patients on ambrisentan when compared to placebo.
- Ambrisentan treatment in patients with IPF should be discontinued and the individual patient’s treatment should be reassessed promptly.
Ambrisentan, a selective endothelin A receptor antagonist is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO functional class I), classified according to the WHO in functional classes II and III to improve the capacities in effort. The efficacy has been demonstrated in idiopathic PAH (IPAH) and in PAH associated connected with connective tissue disease. In the ARTEMIS-IPF clinical study in patients with IPF higher rates of respiratory hospitalisation, mortality events and decreases in respiratory function versus the placebo group was observed. As a result of this study, ambrisentan is contraindicated in patients of IPF. This contraindication includes patients with pulmonary arterial hypertension that is secondary to the idiopathic pulmonary fibrosis (WHO functional class III).
Ambrisentan may be used only in patients with pulmonary arterial hypertension (WHO functional class I).
Here you may view the Dear Healthcare Professional letter.
HALMED has not received any adverse reaction report to Volibris in patients with idiopathic pulmonary fibrosis. HALMED will continue to closely monitor the safe use of Volibris and inform the public promptly about any new information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.