VERQUVO 10 mg/1
vericiguat · TABLET, FILM COATED · Merck Sharp & Dohme LLC
VERQUVO is a tablet, film coated containing vericiguat at 10 mg/1, taken oral. Manufactured by Merck Sharp & Dohme LLC.
Key Facts
- Brand Name
- VERQUVO
- Generic Name
- vericiguat
- NDC Code (Product)
0006-5030- Manufacturer
- Merck Sharp & Dohme LLC
- Strength
- 10 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA214377
- Drug Class
- Soluble Guanylate Cyclase Stimulator [EPC]
- Marketing Start
- 02/01/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 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 & Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose of VERQUVO is 5 mg orally once daily with food. ( 2.1 ) For patients at risk of symptomatic hypotension, the recommended starting dose is 2.5 mg orally once daily with food. ( 2.1 ) Double the dose after 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 unable to swallow whole tablets. ( 2.1 ) 2.1 Recommended Dosage The recommended starting dose of VERQUVO is 5 mg orally once daily with food. For patients at risk of symptomatic hypotension, the recommended starting dose is 2.5 mg orally once daily with food [see Clinical Trials Experience (6.1) ]. Double the dose 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 Clinical Pharmacology (12.3) ] . 2.2 Pregnancy Testing in Females of Reproductive Potential Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with VE…
Contraindications
4 CONTRAINDICATIONS 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) ]. Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. ( 4 , 7.1 ) Pregnancy ( 4 )
Drug Interactions
7 DRUG INTERACTIONS PDE-5 Inhibitors: Concomitant use is not recommended. ( 7.2 ) 7.1 Other Soluble Guanylate Cyclase Stimulators VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators [see Contraindications (4) ] . 7.2 PDE-5 Inhibitors Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension [see Clinical Pharmacology (12.2) ] .
Adverse Reactions
6 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. VERQUVO was evaluated in VICTORIA, which included 2,519 patients treated with VERQUVO (up to 10 mg once daily). The mean duration of VERQUVO exposure was 1 year, and the maximum duration was 2.6 years [see Clinical Studies (14) ] . Table 1 lists adverse drug reactions occurring more commonly with VERQUVO than placebo and in ≥5% of patients treated with VERQUVO in VICTORIA. Table 1: Adverse Drug Reactions Occurring with VERQUVO in VICTORIA Adverse Drug Reaction VERQUVO % N = 2,519 Placebo % N = 2,515 Hypotension 16 15 Anemia 10 7 VELOCITY The safety and tolerability of VERQUVO 5 mg once daily as a starting dose was evaluated in VELOCITY, a single-arm, open-…
Frequently Asked Questions
What is VERQUVO used for?
VERQUVO contains vericiguat. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is VERQUVO a controlled substance?
VERQUVO is not classified as a controlled substance by the DEA.
What is the generic name for VERQUVO?
The generic name for VERQUVO is vericiguat. There are no other listed brand versions of vericiguat.
What is the NDC code for VERQUVO 10 mg/1?
The NDC (National Drug Code) for VERQUVO 10 mg/1 is 0006-5030, listed by Merck Sharp & Dohme LLC.
Other VERQUVO Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)