MSN-SACUBITRIL/VALSARTAN

What it is

MSN-SACUBITRIL/VALSARTAN is a film-coated tablet containing sacubitril and valsartan, available in three strengths: 24/26 mg, 49/51 mg, and 97/103 mg. The medicine exhibits a novel mechanism of action as an angiotensin receptor neprilysin inhibitor (ARNI), simultaneously inhibiting neprilysin via sacubitrilat (the active metabolite of sacubitril) and blocking 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 tablet of 49 mg/51 mg twice daily. 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 by the patient. A starting dose 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. This lower starting dose should also be considered for patients who have risk factors for hypotension, including patients 75 years or older and patients with low systolic blood pressure (100–110 mmHg). MSN-SACUBITRIL/VALSARTAN is for oral use and may be administered with or without food.

Key safety warnings

MSN-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 75 years or older, patients with renal disease and patients with low systolic blood pressure (less than 112 mmHg). In the double-blind period of PARADIGM-HF, 18% of patients treated with sacubitril/valsartan and 12% of patients treated with enalapril reported hypotension as an adverse event. Through its action on the renin-angiotensin-aldosterone system, hyperkalaemia may occur with sacubitril/valsartan; in the double-blind period of PARADIGM-HF, 12% of patients treated with sacubitril/valsartan and 14% of patients treated with enalapril reported hyperkalaemia as an adverse event. Serum potassium should be monitored periodically, especially in patients with risk factors for hyperkalaemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Angioedema has been reported in 0.5% of patients treated with sacubitril/valsartan and 0.2% of patients treated with enalapril in PARADIGM-HF; if angioedema occurs, sacubitril/valsartan should be immediately discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. Black patients may have increased susceptibility to develop angioedema.

Contraindications

MSN-SACUBITRIL/VALSARTAN is contraindicated in patients with hypersensitivity to the active substances, sacubitril or valsartan, or to any of the excipients. Concomitant use with ACE inhibitors is contraindicated, and MSN-SACUBITRIL/VALSARTAN must not be administered within 36 hours of switching from or to an ACE inhibitor. A known history of angioedema related to previous ACE inhibitor or ARB therapy is a contraindication. Hereditary or idiopathic angioedema is a contraindication. Concomitant use with aliskiren in patients with Type 2 diabetes is contraindicated. Severe hepatic impairment, biliary cirrhosis and cholestasis are contraindications. Pregnancy is a contraindication.

Regulatory history

MSN-SACUBITRIL/VALSARTAN 24/26 mg, 49/51 mg, and 97/103 mg film-coated tablets were first listed on the ARTG on 8 September 2025.