vericiguat (Rx)

Brand and Other Names:Verquvo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
  • 10mg

Heart Failure Risk Reduction

Indicated to reduce 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%

Initial: 2.5 mg PO qDay

Maintenance: Double dose ~q2Weeks as tolerated to target dose of 10 mg PO qDay

Dosage Modifications

Renal impairment

  • eGFR ≥15 mL/min/1.73m2 and not on dialysis: No dosage adjustment necessary
  • eGFR <15 mL/min/1.73m2 or on dialysis: Not studied

Hepatic impairment

  • Mild or moderate (Child-Pugh A or B): No dosage adjustment necessary
  • Severe (Child-Pugh C): Not studied

Dosing Considerations

Obtain pregnancy test in females of reproductive potential before initiating

Safety and efficacy not established

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Interactions

Interaction Checker

and vericiguat

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (5)

            • avanafil

              avanafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.

            • riociguat

              riociguat, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Vericiguat is contraindicated with use of other soluble guanylate cyclase (sGC) stimulators.

            • sildenafil

              sildenafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.

            • tadalafil

              tadalafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.

            • vardenafil

              vardenafil, vericiguat. Either increases effects of the other by pharmacodynamic synergism. Contraindicated. Coadministration of vericiguat with PDE-5 inhibitors may result in additive hypotensive effects.

            Serious - Use Alternative (0)

              Monitor Closely (0)

                Minor (0)

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                  Adverse Effects

                  >10%

                  Hypotension (16%); placebo (15%)

                  1-10%

                  Anemia (10%); placebo (7%)

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                  Warnings

                  Black Box Warnings

                  Females of reproductive potential

                  • May cause fetal harm; do not administer to pregnant females
                  • Exclude pregnancy before starting treatment
                  • To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for 1 month after stopping treatment

                  Contraindications

                  Coadministration with other soluble guanylate cyclase (sGC) stimulators

                  Pregnancy

                  Cautions

                  Based on data from animal reproduction studies, may cause fetal harm when administered to pregnant females and its use is contraindicated

                  Drug interaction overview

                  • Coadministration with other sGC stimulators is contraindicated
                  • Coadministration with PDE-5 inhibitors not recommended owing to potential for hypotension
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                  Pregnancy & Lactation

                  Pregnancy

                  Contraindicated; based on data from animal reproduction studies, may cause fetal harm when administered to pregnant females

                  There are no available data regarding use in pregnant females

                  Verify pregnancy status in females of reproductive potential before initiating

                  If patient becomes pregnant during treatment, report drug exposure by calling 1-877-888-4231

                  Animal studies

                  • Administration to pregnant rabbits during organogenesis at ≥4 times the human exposure (total AUC) with the maximum recommended human dose (MRHD) of 10 mg resulted in malformations of the heart and major vessels, as well as increased number of abortions and resorptions
                  • In a prenatal/postnatal toxicity study, oral administration to rats during gestation through lactation caused maternal toxicity, resulting in decreased pup body weight gain (≥10 times the MRHD) and increased pup mortality (24 times the MRHD) during the preweaning period

                  Contraception

                  • Advise females of reproductive potential to use effective contraception during treatment and for 1 month after final dose

                  Lactation

                  Data are not available on the presence of vericiguat in human milk, effects on breastfed infants, or effects on milk production

                  Vericiguat is present in the milk of lactating rats and it is likely that vericiguat or its metabolites are present in human milk

                  Owing to the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Stimulates soluble guanylate-cyclase (sGC), the intracellular receptor for endogenous nitric oxide (NO), which catalyzes cyclic guanosine monophosphate (cGMP) production; cGMP plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling

                  Heart failure is associated with impaired NO synthesis and decreased sGC activity, which may contribute to myocardial and vascular dysfunction

                  By directly stimulating sGC, independently of and synergistically with NO, vericiguat augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation

                  Absorption

                  Bioavailability: 93% when taken with food

                  Peak plasma time: 4 hr (with food)

                  Peak plasma concentration: 350 mcg/L

                  AUC: 6680 mcg⋅h/L

                  Steady-state achieved after ~6 days

                  Effect of food

                  • With high-fat, high-calorie meal
                    • Peak plasma time: 1 hr (fasting); 4 hr (fed)
                    • Peak plasma concentration: Increased by 41%
                    • AUC: Increased by 44%

                  Distribution

                  Vd: 44 L (healthy volunteers)

                  Protein bound: ~98%

                  Metabolism

                  Primarily undergoes glucuronidation by UGT1A9 and to a lesser extent by UGT1A1 to form an inactive N-glucuronide metabolite

                  CYP-mediated metabolism is a minor clearance pathway (<5%)

                  Elimination

                  Half-life: 30 hr (patients with HF)

                  Clearance: 1.6 L/hr (healthy volunteers)

                  Excretion, healthy volunteers

                  • Urine: ~53% (primarily as inactive metabolite)
                  • Feces: 45% (primarily as unchanged drug)
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                  Administration

                  Oral Administration

                  Take with food to improve bioavailability

                  Swallow table whole

                  Difficulty swallowing

                  • If unable to swallow tablet whole, may crush and mix with water immediately before administration

                  Missed dose

                  • Take missed dose as soon as remembered on the same day of the missed dose
                  • Do not take 2 doses on the same day to make up for a missed dose

                  Storage

                  Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.