Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Bayer AG, 51368 Leverkusen, Germany
Verquvo is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring IV therapy (see section 5.1).
Vericiguat is administered in conjunction with other heart failure therapies.
Before starting vericiguat, care should be taken to optimise volume status and diuretic therapy to stabilise patients after the decompensation event, particularly in patients with very high NT-proBNP levels (see section 5.1).
The recommended starting dose is 2.5 mg vericiguat 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.
If patients experience tolerability issues (symptomatic hypotension or systolic blood pressure [SBP] less than 90 mmHg), temporary down-titration or discontinuation of vericiguat is recommended (see section 4.4).
Treatment should not be initiated in patients with SBP <100 mmHg (see section 4.4).
If a dose is missed, it should be taken as soon as the patient remembers on the same day of the missed dose. Patients should not take two doses of vericiguat on the same day.
No dose adjustment is required for elderly patients (see sections 5.1 and 5.2).
No dose adjustment is required in patients with estimated glomerular filtration rate (eGFR) >15 mL/min/1.73 m² (without dialysis). Treatment with vericiguat is not recommended in patients with eGFR <15 mL/min/1.73 m² at treatment initiation or on dialysis (see sections 4.4 and 5.2).
No dose adjustment is required in patients with mild or moderate hepatic impairment. Treatment with vericiguat is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
The safety and efficacy of vericiguat in children and adolescents aged below 18 years have not yet been established. No clinical data are available. Undesirable effects were observed on growing bone in non-clinical studies (see section 5.3).
For oral use. Verquvo should be taken with food (see section 5.2).
For patients who are unable to swallow whole tablets, Verquvo may be crushed and mixed with water immediately before administration (see section 5.2).
Overdose of vericiguat may lead to hypotension. If necessary, symptomatic treatment should be provided. The medicinal product is unlikely to be removed by haemodialysis due to high protein binding.
3 years.
This medicinal product does not require any special storage conditions.
PVC/PVDC/Aluminium foil blisters in cartons of 14, 28 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 × 1 or 100 × 1 film-coated tablets.
PP/Aluminium foil blisters in cartons of 14, 28 or 98 film-coated tablets or perforated unit dose blisters in cartons of 10 × 1 or 100 × 1 film-coated tablets.
HDPE bottles with a PP screw cap containing 100 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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