VALTRESTO

What it is

Valtresto is a film-coated tablet containing sacubitril and valsartan. Valtresto is available in three strengths: 24/26 mg, 49/51 mg, and 97/103 mg.

Approved indications

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

Dosing overview

The recommended starting dose of Valtresto 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). The dose should be doubled every 2–4 weeks to the target dose of 97 mg/103 mg twice daily, as tolerated by the patient. Valtresto should be initiated, and up-titration conducted, by a physician experienced with the treatment of heart failure.

Key safety warnings

Sacubitril/valsartan is contraindicated with concomitant use of an angiotensin-converting enzyme (ACE) inhibitor due to the potential risk of angioedema. Sacubitril/valsartan must not be administered until 36 hours after the last dose of ACE inhibitor therapy, and at least 36 hours must elapse after the last dose of sacubitril/valsartan before ACE inhibitor therapy is initiated. Sacubitril/valsartan should not be co-administered with an ARB due to the angiotensin II receptor blocking activity of sacubitril/valsartan. If patients experience tolerability issues including systolic blood pressure of 95 mmHg or lower, symptomatic hypotension, hyperkalaemia, or renal dysfunction, consideration should be given to adjustment of concomitant medications, or to temporary down-titration or discontinuation of Valtresto.

Contraindications

Treatment should not be initiated in patients with serum potassium level greater than 5.4 mmol/L or with systolic blood pressure less than 100 mmHg.

Regulatory history

Valtresto was registered on the ARTG on 3 April 2023, with six variants listed covering the 24/26 mg, 49/51 mg, and 97/103 mg strengths in both blister and bottle pack configurations. The Pharmaceutical Benefits Scheme Advisory Committee recommended the listing in November 2017 for an amendment to expand eligibility criteria for sacubitril and valsartan to include patients with chronic heart failure with reduced ejection fraction who are symptomatic despite optimal therapy with an ACE inhibitor or ARB.