Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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)
Adverse Effects
>10%
Hypotension (16%); placebo (15%)
1-10%
Anemia (10%); placebo (7%)
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
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.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)
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
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