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Mechanism of action
VERQUVO® (vericiguat) employs a novel MOA for the treatment of HF, resulting in smooth muscle relaxation and vasodilation1
VERQUVO augments cGMP levels by addressing impaired NO-sGC-cGMP pathway, which is important in the pathophysiology of HF.
HF is associated with low NO bioavailability, decreased sGC activity, and reduced cGMP synthesis leading to vascular dysfunction and myocardial dysfunction
VERQUVO directly stimulates sGC, independently of and synergistically with NO, to produce more cGMP leading to smooth muscle relaxation and vasodilation which may improve cardiac function.
cGMP = cyclic guanosine monophosphate; HF = heart failure; MOA = mechanism of action; MOD= mechanism of disease; NO = nitric oxide; sGC = soluble guanylate cyclase
Reference:
Armstrong PW, Pieske B, Anstrom KJ, et al. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 2020;382(20):1883-1893.
Indication
VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg is indicated 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 less than 45%.
Selected Safety Information
WARNING: EMBRYO-FETAL TOXICITY
Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.
VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.
VERQUVO is contraindicated in pregnancy.
Embryo-Fetal Toxicity: Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.
There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency ≥5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).
Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended due to the potential for hypotension.
There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.
Before prescribing VERQUVO, please read the accompanying Prescribing information including the Boxed Warning about embryo-fetal toxicity. The Medication guide also is available.
VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg is indicated 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 less than 45%.
Selected Safety Information
WARNING: EMBRYO-FETAL TOXICITY
Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.
VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.
VERQUVO is contraindicated in pregnancy.
Embryo-Fetal Toxicity: Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.
There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency ≥5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).
Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended due to the potential for hypotension.
There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.
Before prescribing VERQUVO, please read the accompanying Prescribing information including the Boxed Warning about embryo-fetal toxicity. The Medication guide also is available.
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TERMS AND CONDITIONS
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IndicationIndication
VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg is indicated 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 less than 45%.
VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg is indicated to reduce the risk
VERQUVO® (vericiguat) tablets 2.5 mg, 5 mg, 10 mg is indicated 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 less than 45%.
Selected Safety InformationSelected Safety Information
WARNING: EMBRYO-FETAL TOXICITY
Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.
VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.
VERQUVO is contraindicated in pregnancy.
Embryo-Fetal Toxicity: Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.
There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to VERQUVO during pregnancy. Health care providers should report any prenatal exposure by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency ≥5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).
Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended due to the potential for hypotension.
There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.
Before prescribing VERQUVO, please read the accompanying Prescribing information including the Boxed Warning about embryo-fetal toxicity. The Medication guide also is available.
WARNING: EMBRYO-FETAL TOXICITY
Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment
Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.
