VERQUVO- vericiguat tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

VERICIGUAT (UNII: LV66ADM269) (VERICIGUAT - UNII:LV66ADM269)

Dostopno od:

Merck Sharp & Dohme LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

VERQUVO® is indicated to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45% [see Clinical Studies (14)] . VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators [see Drug Interactions (7.1)] . VERQUVO is contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Pregnancy Surveillance Program There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure to VERQUVO by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com. Risk Summary Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman and is contraindicated during pregnancy [see Co

Povzetek izdelek:

VERQUVO (vericiguat) is available as round, film-coated, biconvex tablets in the following configurations: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (between 59°F to 86°F). See USP for Controlled Room Temperature.

Status dovoljenje:

New Drug Application

Navodilo za uporabo

Merck Sharp & Dohme LLC
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration
Revised: 07/2023
MEDICATION GUIDE
VERQUVO® (ver-KYU-voh)
(vericiguat)
tablets
What is the most important information I should know about VERQUVO?
VERQUVO may cause birth defects if taken during pregnancy.
•
Females must not be pregnant when they start taking VERQUVO.
•
Females who are able to get pregnant:
•
Your healthcare provider will do a pregnancy test to make sure that
you are not pregnant
before you start taking VERQUVO.
•
You must use effective forms of birth control during treatment and for
1 month after you
stop treatment with VERQUVO. Talk to your healthcare provider about
forms of birth
control that you may use to prevent pregnancy during treatment with
VERQUVO.
•
Tell your healthcare provider right away if you become pregnant or
think you are pregnant
during treatment with VERQUVO.
•
There is a Pregnancy Surveillance Program that monitors pregnancy
outcomes in women
exposed to VERQUVO during pregnancy. Patients should report any
exposure to
VERQUVO during pregnancy by calling 1-877-888-4231 or at
https://pregnancyreporting.verquvo-us.com.
What is VERQUVO?
VERQUVO is a prescription medicine used in adults who are having
symptoms of their chronic (long-
lasting) heart failure, who have had a recent hospitalization or the
need to receive intravenous (IV)
medicines and have an ejection fraction (amount of blood pumped with
each heartbeat) of less than 45
percent:
•
to reduce the risk of dying and
•
to reduce the need to be hospitalized
Heart failure happens when your heart is weak and cannot pump enough
blood to your lungs and the rest
of your body.
It is not known if VERQUVO is safe and effective in children.
Do not take VERQUVO if you:
•
are taking another medicine called a soluble guanylate cyclase
stimulator (sGC). Ask your
healthcare provider if you are not sure if you are taking an sGC
medicine.
•
are pregnant. See “What is the most important information I shoul

Lastnosti izdelka

VERQUVO- VERICIGUAT TABLET, FILM COATED
MERCK SHARP & DOHME LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERQUVO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VERQUVO.
VERQUVO (VERICIGUAT) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2021
WARNING: EMBRYO-FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DO NOT ADMINISTER VERQUVO TO A PREGNANT FEMALE BECAUSE IT MAY CAUSE
FETAL HARM.
(4, 5.1, 8.1)
FEMALES OF REPRODUCTIVE POTENTIAL: EXCLUDE PREGNANCY BEFORE THE START
OF TREATMENT.
TO PREVENT PREGNANCY, FEMALES OF REPRODUCTIVE POTENTIAL MUST USE
EFFECTIVE FORMS
OF CONTRACEPTION DURING TREATMENT AND FOR ONE MONTH AFTER STOPPING
TREATMENT.
(2.2, 5.1, 8.3)
INDICATIONS AND USAGE
VERQUVO is a soluble guanylate cyclase (sGC) stimulator, indicated to
reduce the risk of cardiovascular
death and heart failure (HF) hospitalization following a
hospitalization for heart failure or need for
outpatient IV diuretics, in adults with symptomatic chronic HF and
ejection fraction less than 45%. (1)
DOSAGE AND ADMINISTRATION
The recommended starting dose of VERQUVO is 2.5 mg orally once daily
with food. (2.1)
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. (2.1)
Tablets may be crushed and mixed with water for patients who have
difficulty swallowing. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg and 10 mg (3)
CONTRAINDICATIONS
Patients with concomitant use of other soluble guanylate cyclase (sGC)
stimulators. (4, 7.1)
Pregnancy (4)
ADVERSE REACTIONS
Most common adverse reactions reported in ≥5% are hypotension and
anemia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MERCK SHARP & DOHME LLC
AT 1-877-
888-4231 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
PDE-5 Inhibitors: Concomitant use is not recommended. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended (8.2)
S