ARX-SACUBITRIL/VALSARTAN

What it is

ARX-SACUBITRIL/VALSARTAN is a film-coated tablet containing sacubitril and valsartan. The medicine is available in three strengths: 24/26, 49/51, and 97/103 mg tablets. ARX-SACUBITRIL/VALSARTAN is an angiotensin receptor neprilysin inhibitor (ARNI) that simultaneously inhibits neprilysin via the active metabolite sacubitrilat and blocks the angiotensin II type-1 receptor via valsartan.

Approved indications

— Treatment of chronic heart failure (NYHA Class II-IV) with reduced ejection fraction in adult patients.

Dosing overview

The recommended starting dose is one 49/51 mg tablet twice daily, doubled after 2 to 4 weeks to a target maintenance dose of one 97/103 mg tablet twice daily, as tolerated. A starting dose of one 24/26 mg tablet taken twice daily is recommended for patients not currently taking an ACE inhibitor or ARB, or patients previously taking low doses of these agents. A starting dose of one 24/26 mg tablet taken twice daily should be considered for patients with risk factors for hypotension, including patients aged 75 years or older and patients with systolic blood pressure of 100 to 110 mmHg. ARX-SACUBITRIL/VALSARTAN may be administered with or without food.

Key safety warnings

ARX-SACUBITRIL/VALSARTAN must not be administered with an ACE inhibitor due to the risk of angioedema, and must not be initiated until 36 hours after taking the last dose of ACE inhibitor therapy. Sacubitril/valsartan lowers blood pressure and may cause symptomatic hypotension, especially in patients aged 75 years or older, patients with renal disease, and patients with systolic blood pressure below 112 mmHg. Through its action on the renin-angiotensin-aldosterone system, hyperkalaemia may occur with sacubitril/valsartan; in the PARADIGM-HF trial, 12% of patients treated with sacubitril/valsartan reported hyperkalaemia as an adverse event. Angioedema has been reported in 0.5% of patients treated with sacubitril/valsartan in PARADIGM-HF; if angioedema occurs, the medicine should be immediately discontinued and sacubitril/valsartan must not be re-administered. Black patients may have increased susceptibility to develop angioedema.

Contraindications

Hypersensitivity to the active substances, sacubitril or valsartan, or to any of the excipients. Concomitant use with ACE inhibitors. Known history of angioedema related to previous ACE inhibitor or ARB therapy. Hereditary or idiopathic angioedema. Concomitant use with aliskiren in patients with Type 2 diabetes. Severe hepatic impairment, biliary cirrhosis and cholestasis. Pregnancy.

PBS listing

Information regarding PBS listing is not available in the provided sources.

Regulatory history

ARX-SACUBITRIL/VALSARTAN was first listed on the ARTG on 8 September 2025, with three strengths registered under licence category RE: the 24/26 mg (ARTG 456085), 49/51 mg (ARTG 456086), and 97/103 mg (ARTG 456087) film-coated tablets.