OMTRALO

What it is

Omtralo is a film-coated tablet containing sacubitril and valsartan. It is available in three strengths: 24/26 mg, 49/51 mg, and 97/103 mg. Omtralo exhibits the mechanism of action of an angiotensin receptor neprilysin inhibitor (ARNI) by simultaneously inhibiting neprilysin via sacubitrilat (the active metabolite of sacubitril) and by blocking the angiotensin II type-1 (AT1) 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 of Omtralo 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 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 (≥100 to 110 mmHg). A starting dose of Omtralo 24 mg/26 mg twice daily is recommended in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). A starting dose of Omtralo 24 mg/26 mg twice daily is recommended for patients with moderate hepatic impairment (Child-Pugh B classification).

Key safety warnings

Omtralo must not be administered with an ACE inhibitor due to the risk of angioedema. Omtralo must not be initiated until 36 hours after taking the last dose of ACE inhibitor therapy. Omtralo 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 (<112 mmHg). Treatment should not be initiated if the serum potassium level is >5.4 mmol/L. Through its action on the renin-angiotensin-aldosterone system, hyperkalaemia may occur with Omtralo. Angioedema has been reported in 0.5% of patients treated with Omtralo. If angioedema occurs, Omtralo should be immediately discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. As a consequence of inhibiting the renin-angiotensin-aldosterone system, the use of Omtralo may be associated with decreased renal function.

Contraindications

Omtralo is contraindicated in patients with hypersensitivity to the active substances or excipients, and in concomitant use with ACE inhibitors. Omtralo must not be administered within 36 hours of switching from or to an ACE inhibitor. Omtralo is contraindicated in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy, and in patients with hereditary or idiopathic angioedema. Omtralo is contraindicated in concomitant use with aliskiren in patients with Type 2 diabetes. Omtralo is contraindicated in severe hepatic impairment, biliary cirrhosis and cholestasis. Omtralo is contraindicated in pregnancy.

PBS listing

No source document provides PBS listing information for Omtralo.

Regulatory history

Omtralo 24/26 mg, 49/51 mg, and 97/103 mg film-coated tablets were first listed on the ARTG on 31 March 2025 under licence category RE.