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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            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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            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.
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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.