VERQUVO

What it is

VERQUVO is indicated in addition to standard of care therapy for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45% who are stabilised after a recent heart failure decompensation event requiring admission and/or IV diuretic therapy. VERQUVO is a soluble guanylate cyclase (sGC) stimulator.

Approved indications

— Symptomatic chronic heart failure in adult patients with reduced ejection fraction less than 45% who are stabilised after a recent heart failure decompensation event requiring admission and/or IV diuretic therapy.

Dosing overview

VERQUVO should be initiated under the supervision of a cardiologist. The recommended starting dose is 2.5 mg once daily. The dose should be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. VERQUVO should be taken with food. Treatment should not be initiated in patients with systolic blood pressure less than 100 mmHg.

Key safety warnings

VERQUVO may cause symptomatic hypotension. In the VICTORIA clinical trial, adverse events determined by the investigator to be events of symptomatic hypotension were reported in 9.1% of patients treated with vericiguat and 7.9% of patients treated with placebo and were considered serious in 1.2% of patients treated with vericiguat and 1.5% of patients treated with placebo. Consider the potential for symptomatic hypotension in patients with hypovolaemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, history of hypotension, or concomitant treatment with antihypertensives or organic nitrates. Concomitant use of VERQUVO and phosphodiesterase-5 (PDE-5) inhibitors, such as sildenafil, has not been studied in patients with heart failure and is therefore not recommended due to the potential increased risk for symptomatic hypotension. Undesirable effects were observed on growing bone in non-clinical studies.

Contraindications

VERQUVO is contraindicated in patients with hypersensitivity to the active substance or any of the excipients and concomitant use of other soluble guanylate cyclase (sGC) stimulators, such as riociguat.

PBS listing

VERQUVO is listed on the PBS in 2.5 mg, 5 mg, and 10 mg tablet strengths with authority required streamlined restriction and an ex-manufacturer price of A$120.40 per item.

Regulatory history

VERQUVO vericiguat 2.5 mg, 5 mg, and 10 mg film-coated tablets were first registered on the ARTG on 15 November 2021. The PBAC considered the medicine not recommended in March 2022. The PBAC recommended VERQUVO in July 2022 for symptomatic chronic heart failure in patients with reduced ejection fraction less than 45% who are stabilised after a recent decompensation heart failure event requiring hospitalisation and/or intravenous diuretic therapy.