VERQUVO

Country: Indonesia

Language: Indonesian

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Available from:

BAYER INDONESIA - Indonesia -

Dosage:

5.00 MG

Pharmaceutical form:

TABLET SALUT SELAPUT

Composition:

VERICIGUAT

Units in package:

DUS, 1 BLISTER @ 14 TABLET SALUT SELAPUT

Class:

Obat

Manufactured by:

BAYER AG - Federal Republic of Germany

Authorization status:

Berlakus/d 30-10-2028

Authorization date:

2023-10-30

Summary of Product characteristics

ID/Verquvo/Vericiguat 2.5, 5 & 10 mg - Film Coated Tablet/CCDS#02
1
VERQUVO
®
FILM-COATED TABLET
NAME OF THE DRUG
VERQUVO 2.5 mg (vericiguat 2.5 mg)
VERQUVO 5 mg (vericiguat 5 mg)
VERQUVO 10 mg (vericiguat 10 mg)
PHARMACEUTICAL FORM
Film-coated tablets.
VERQUVO 2.5 mg film-coated tablets
Round, biconvex, white film-coated tablet with a diameter of 7 mm,
debossed with “2.5” on one side and “VC” on the other
side.
VERQUVO 5 mg f
ilm-coated tablets
Round, biconvex, brown-red film-coated tablet with a diameter of 7 mm,
debossed with “5” on one side and “VC” on the other
side.
VERQUVO 10 mg f
ilm-coated tablets
Round, biconvex, yellow-orange film-coated tablet with a diameter of 9
mm, debossed with “10” on one side and “VC” on the
other side.
INDICATIONS AND USAGE
Verquvo is indicated for the treatment of symptomatic chronic heart
failure in adult patients with reduced ejection fraction less
than 45% who are stabilized with IV diuretic therapy after
hospitalization for heart failure, occurring on guideline-based
medical
therapy, including angiotensin-converting enzyme (ACE) inhibitors or
angiotensin II receptor blockers (ARB), betablockers,
mineralocorticoid receptor antagonists (MRA), and a combination of an
angiotensin receptor and neprilysin inhibitor (ARNI).
DOSAGE AND ADMINISTRATION
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.
•
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
•
For patients who are unable to swallow whole tablets, VERQUVO may be
crushed and mixed with water immediately
before administration _[see CLINICAL PHARMACOLOGY, Pharmacokinetics]_.
Verquvo is administered in conjunction with other heart failure
therapies (see Clinical Studies).
M