Verquvo

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  • CHF and arrhythmias
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Verquvo Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Vericiguat 2.5mg, 5mg, 10mg; tabs.

    Pharmacological Class

    Soluble guanylate cyclase (sGC) stimulator.

    How Supplied

    Tabs 2.5mg, 5mg—14, 30, 100 (10×10 blisters); 10mg—30, 90, 100 (10×10 blisters)

    How Supplied

    Round, film-coated, tablets:

    • 2.5mg: white; marked with 2.5/VC
    • 5mg: brown-red; marked with 5/VC
    • 10mg: yellow-orange; marked with 10/VC

    Storage

    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). 

    Manufacturer

    Merck & Co., Inc.

    Generic Availability

    NO

    Verquvo Indications

    Indications

    To reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction <45%.

    Verquvo Dosage and Administration

    Prior to Treatment Evaluations

    Obtain pregnancy test in females of reproductive potential.

    Adult

    Tabs may be crushed and mixed with water, if unable to swallow whole. Take with food. Initially 2.5mg once daily; then double the dose approx. every 2 weeks. Target dose: 10mg once daily as tolerated.

    Children

    Not established.

    Verquvo Contraindications

    Contraindications

    Pregnancy. Concomitant other sGC stimulators.

    Verquvo Boxed Warnings

    Boxed Warning

    Embryo-fetal toxicity.

    Verquvo Warnings/Precautions

    Warnings/Precautions

    Embryo-fetal toxicity. Exclude pregnancy status prior to initiation. Advise females of reproductive potential to use effective contraception during and for at least 1 month after the last dose. Nursing mothers: not recommended. Severe hepatic impairment or eGFR <15mL/min/1.73m2 at treatment initiation or on dialysis: not studied.

    Pregnancy Considerations

    Verquvo may cause fetal harm and is contraindicated in pregnancy. 

    Report Verquvo exposure by calling (877) 888-4231.

    Nursing Mother Considerations

    No data on the presence of vericiguat in human milk, the effects on the breastfed infant, or the effects on milk production.

    Women are advised not to breastfeed during treatment with Verquvo.

    Pediatric Considerations

    Safety and effectiveness of Verquvo have not been established in pediatric patients. 

    Geriatric Considerations

    No dosage adjustment is required. No overall differences in safety or efficacy were observed between patients 65 years and older vs younger patients.

    Renal Impairment Considerations

    No dosage adjustment is recommended in patients with eGFR ≥15mL/min/1.73m2 who are not on dialysis.

    Verquvo has not been studied in patients with eGFR<15mL/min/1.73m2 at treatment initiation or on dialysis.

    Hepatic Impairment Considerations

    Mild or moderate hepatic impairment: No dosage adjustment is recommended.

    Severe hepatic impairment: Not studied.

    Other Considerations for Specific Populations

    Females of reproductive age: Use effective contraception during treatment and for at least 1 month after the final dose.

    Verquvo Pharmacokinetics

    Absorption

    The absolute bioavailability of vericiguat is 93% when taken with food. 

    Results were comparable when Verquvo was administered orally as a whole tablet or as a crushed tablet in water.

    Distribution

    Protein binding (primarily to serum albumin) of vericiguat is about 98%. 

    Metabolism

    Vericiguat primarily undergoes glucuronidation by UGT1A9 and to a lesser extent, by UGT1A1.

    Elimination

    Half-life of vericiguat is 30 hours.

    Approximately 53% of the dose is excreted in urine and 45% in feces.

    Verquvo Interactions

    Interactions

    See Contraindications. Concomitant PDE-5 inhibitors: not recommended.

    Interactions

    Contraindicated in patients with concomitant use of other soluble guanylate cyclase stimulators.

    Concomitant use with PDE-5 inhibitors: Not recommended because of the potential for hypotension.

    • Concomitant use of Verquvo 10mg with single doses of sildenafil (25, 50, or 100mg) was associated with additional seated blood pressure reduction of up to 5.4 mm Hg (systolic/diastolic BP, MAP), compared with administration of Verquvo alone.

    Verquvo Adverse Reactions

    Adverse Reactions

    Hypotension, anemia.

    Verquvo Clinical Trials

    Clinical Trials

    The approval of Verquvo was based on data from the double-blind, placebo-controlled phase 3 VICTORIA trial that included 5050 adult patients with symptomatic chronic heart failure (New York Heart Association class II-IV) and left ventricular ejection fraction (LVEF) less than 45% following a worsening heart failure event.

    Patients were randomly assigned to receive vericiguat 10mg once daily (n=2526) or placebo (n=2524) in combination with heart failure standard of care therapy. The population was 64% Caucasian, 22% Asian, and 5% Black. The mean age was 67 years and 76% were male.

    Results showed that vericiguat was superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization at a median follow-up of 11 months based on a time-to-event analysis (hazard ratio [HR] 0.90; 95% CI, 0.82-0.98; P =.019). Treatment with vericiguat was associated with a 4.2% annualized absolute risk reduction compared with placebo. Additionally, vericiguat reduced the incidence of heart failure hospitalizations (27.4% vs 29.6% for placebo; HR 0.90; 95% CI, 0.81-1.00) and cardiovascular death (16.4% vs 17.5% for placebo; HR 0.93; 95% CI, 0.81-1.06).

    Among patients in the highest baseline NT-proBNP quartile, the estimated HRs for both cardiovascular death (HR, 1.16; 95% CI, 0.95-1.43) and first heart failure hospitalization (HR, 1.19; 95%CI,  0.9-1.44) were unfavorable, in contrast to the estimated HRs for patients in the 3 quartiles with lower NT-proBNP levels.

    Verquvo Note

    Not Applicable

    Verquvo Patient Counseling

    Patient Counseling

    Missed dose: Take as soon as remembered on the same day of the missed dose; do not take 2 doses on the same day.

    Report pregnancy as Verquvo may cause fetal harm and is contraindicated in pregnancy. 

    Do not breastfeed during treatment with Verquvo.

    Females of reproductive potential: Use effective contraception during treatment and for 1 month after the final dose.

    Cost Savings Program

    The Merck Access Program

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