SACUVANCE

What it is

Sacuvance is a film-coated tablet containing sacubitril and valsartan in three strengths: 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg. Sacuvance exhibits the novel mechanism of action of an angiotensin receptor neprilysin inhibitor by simultaneously inhibiting neprilysin via sacubitrilat (the active metabolite of sacubitril) and by blocking the angiotensin II type-1 receptor via valsartan.

Approved indications

— Chronic heart failure (NYHA Class II to IV) with reduced ejection fraction in adult patients.

Dosing overview

The recommended starting dose of Sacuvance is one tablet of 49 mg/51 mg twice daily, except in specific situations, and the dose should be doubled after 2 to 4 weeks to the target maintenance dose of one tablet of 97 mg/103 mg twice daily, as tolerated. A starting dose of Sacuvance of one tablet of 24 mg/26 mg taken twice daily is recommended for patients not currently taking an ACE inhibitor or an ARB, or patients previously taking low doses of these agents. A starting dose of one tablet of 24 mg/26 mg taken twice daily should be considered for patients who have risk factors for hypotension, including patients aged 75 years or older and patients with low systolic blood pressure (systolic blood pressure 100 to 110 mmHg).

Key safety warnings

Sacuvance 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. Sacuvance lowers blood pressure and may cause symptomatic hypotension, especially in patients aged 75 years or older, patients with renal disease and patients with low systolic blood pressure (less than 112 mmHg). Treatment should not be initiated if the serum potassium level is greater than 5.4 mmol/litre, and through its action on the renin-angiotensin-aldosterone system, hyperkalaemia may occur with Sacuvance. Angioedema has been reported in 0.5% of patients treated with Sacuvance and if angioedema occurs, Sacuvance should be immediately discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred.

Contraindications

Sacuvance is contraindicated in patients with hypersensitivity to the active substances, sacubitril, valsartan, or to any of the excipients, and in concomitant use with ACE inhibitors. Sacuvance is contraindicated in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy or with hereditary or idiopathic angioedema. Sacuvance is contraindicated for concomitant use with aliskiren in patients with type 2 diabetes. Sacuvance is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and cholestasis, and in pregnancy.

Regulatory history

Sacuvance was registered on the ARTG on 6 January 2026 in six formulations across blister pack and bottle pack presentations in the 24/26 mg, 49/51 mg, and 97/103 mg strengths.