Posology : מינונים

4.2   Posology and method of administration

Posology
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).

Missed dose
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.

Special populations

Elderly
No dose adjustment is required for elderly patients (see sections 5.1 and 5.2).

Renal impairment
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).

Hepatic impairment
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).

Paediatric population
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).


Method of administration

For oral use. Verquvo should be taken with food (see section 5.2).
2
Crushed tablets
For patients who are unable to swallow whole tablets, Verquvo may be crushed and mixed with water immediately before administration (see section 5.2).