VERQUVO FILM-COATED TABLET 5MG [SIN16342P]

Product Info

VERQUVO FILM-COATED TABLET 5MG

[SIN16342P]

1. INDICATIONS AND USAGE

VERQUVO (vericiguat) 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. Vericiguat is administered in combination with other HF therapies [see 9. CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2. DOSAGE AND ADMINISTRATION

Before starting VERQUVO, care should be taken to optimise volume status and diuretic therapy, as well as other guideline-directed heart failure therapies, to stabilise patients after the decompensation event, particularly in patients with very high NT-proBNP levels [see 9. CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.1 Adults

• The recommended starting dose of VERQUVO is 2.5 mg once daily, taken with food.

• Double the dose of VERQUVO approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient.

• For patients who are unable to swallow whole tablets, VERQUVO may be crushed and mixed with water immediately before administration [see 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

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 VERQUVO on the same day.

2.2 Pediatric Patients
Safety and efficacy of VERQUVO have not been established in patients less than 18 years of age [see 6. USE IN SPECIFIC POPULATIONS, 6.3 Pediatric Use and 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.3 Geriatric Patients
No dosage adjustment of VERQUVO is required for geriatric patients [see 6. USE IN SPECIFIC POPULATIONS, 6.4 Geriatric Use and 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.4 Renal Impairment
No dose adjustment of VERQUVO is required in patients with estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73m² (without dialysis). VERQUVO has not been studied in patients with eGFR <15 mL/min/1.73m² at treatment initiation or on dialysis and is therefore not recommended in these patients [see 6. USE IN SPECIFIC POPULATIONS, 6.5 Renal Impairment, 9. CLINICAL STUDIES, and 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.5 Hepatic Impairment
No dose adjustment of VERQUVO is required in patients with mild or moderate hepatic impairment. VERQUVO has not been studied in patients with severe hepatic impairment and is therefore not recommended in these patients [see 6. USE IN SPECIFIC POPULATIONS, 6.6 Hepatic Impairment and 10. CLINICAL PHARMACOLOGY, 10.4 Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

3. CONTRAINDICATIONS

VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators, such as riociguat [see 5. DRUG INTERACTIONS AND OTHER FORMS OF INTERACTIONS, 5.2 Other Soluble Guanylate Cyclase Stimulators – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Hypersensitivity to the active substance or to any of the excipients listed in section 14.2 Composition – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.