PULMORIS

What it is

Pulmoris contains ambrisentan and is available in 5 mg and 10 mg film-coated tablets. Ambrisentan is an orally active, propanoic acid-class, endothelin receptor antagonist (ERA) that is selective for the endothelin type A (ETA) receptor.

Approved indications Pulmoris is indicated for the treatment of:

— idiopathic pulmonary arterial hypertension (PAH) — pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD), in patients with WHO functional class II, III or IV symptoms

Dosing overview

Pulmoris should be taken orally at a dose of 5 mg once daily. Additional benefit may be obtained by increasing the dose to 10 mg. When co-administered with ciclosporin, the dose of ambrisentan should be limited to 5 mg once daily. Pulmoris can be administered with or without food.

Key safety warnings

Pulmoris may cause birth defects and is contraindicated in pregnancy. Teratogenicity is a class effect of endothelin receptor antagonists. Use of ambrisentan is contraindicated in women who are, or could become pregnant. Hepatic enzyme elevations have been observed with endothelin receptor antagonists (ERAs). The cumulative incidence of serum aminotransferase abnormalities >3xULN in all phase II and III studies for ambrisentan as a single agent (including respective open label extensions) was 17 of 483 (3.5%) subjects over a mean exposure duration of 79.5 weeks. Monthly monitoring of aminotransferases is warranted for the first 6 months after ambrisentan treatment is initiated. Reductions in haemoglobin concentrations and haematocrit have been associated with ERAs including ambrisentan, and there have been cases where this has resulted in anaemia, sometimes requiring transfusion. It is recommended that haemoglobin is measured prior to initiation of ambrisentan, again at 1 month and periodically thereafter. Peripheral oedema has been observed with ERAs including ambrisentan. Post-marketing reports of fluid retention occurring within weeks after starting ambrisentan have been received and, in some cases, have required intervention with a diuretic or hospitalisation for fluid management or decompensated heart failure.

Contraindications

Pulmoris is contraindicated in: pregnancy; women of child-bearing potential who are not using reliable contraception; patients with severe hepatic impairment (with or without cirrhosis); 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); patients with idiopathic pulmonary fibrosis (IPF) with or without secondary pulmonary hypertension; and patients who exhibit or may exhibit hypersensitivity to ambrisentan or to any of the excipients.

PBS listing

Information regarding PBS listing, item count, restriction type, and ex-manufacturer price is not contained in the provided source documents.

Regulatory history

Pulmoris was first listed on the ARTG on 14 September 2017 for both the 5 mg and 10 mg tablet strengths under licence category RE.