SACUBITRIL/VALSARTAN LUPIN

What it is

Sacubitril/Valsartan Lupin contains sacubitril and valsartan. The medicine is available in three strengths: 24/26 mg, 49/51 mg, and 97/103 mg film-coated tablets, where both drug substances are combined as a sodium salt complex. It is for oral use. Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor that simultaneously inhibits neprilysin via sacubitrilat (the active metabolite of sacubitril) 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 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. A starting dose of 24 mg/26 mg taken twice daily should also be considered for patients who have risk factors for hypotension, including patients aged 75 years or older and patients with systolic blood pressure between 100 and 110 mmHg. A starting dose of 24 mg/26 mg twice daily is recommended in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m²). No dose adjustment is required for patients with mild hepatic impairment; a starting dose of 24 mg/26 mg twice daily is recommended for patients with moderate hepatic impairment.

Key safety warnings

Sacubitril/Valsartan Lupin 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 Lupin should not be co-administered with an ARB due to its angiotensin II receptor blocking activity. 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 low systolic blood pressure (less than 112 mmHg). When initiating therapy or during dose titration, blood pressure should be monitored routinely. Treatment should not be initiated if the serum potassium level is above 5.4 mmol/L, as hyperkalaemia may occur with sacubitril/valsartan through its action on the renin–angiotensin–aldosterone system. 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; if angioedema occurs, sacubitril/valsartan should be immediately discontinued and appropriate therapy and monitoring should be provided. Sacubitril/valsartan must not be used in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy or with hereditary or idiopathic angioedema. Use of sacubitril/valsartan may be associated with decreased renal function; renal function should be assessed before initiation of therapy and during treatment, and serum creatinine should be closely monitored, with dose reduction or interruption in patients who develop a clinically significant decrease in renal function.

Contraindications

Hypersensitivity to sacubitril, valsartan, or any of the excipients. Concomitant use with ACE inhibitors. Known history of angioedema related to previous ACE inhibitor or ARB therapy, or 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 on PBS listing, including listed strengths, item count, restriction type, and ex-manufacturer price, is not available in the provided documents.

Regulatory history

Sacubitril/Valsartan Lupin 24/26 mg, 49/51 mg, and 97/103 mg film-coated tablets were first registered on the ARTG on 8 September 2025.