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Drug overview for VERQUVO (vericiguat):
Generic name: vericiguat (VER-i-SIG-ue-at)
Drug class: Soluble Guanylate Cyclase (sGC) Stimulators
Therapeutic class: Cardiovascular Therapy Agents
Vericiguat, a soluble guanylate cyclase (sGC) stimulator, is a vasodilator.
No enhanced Uses information available for this drug.
Generic name: vericiguat (VER-i-SIG-ue-at)
Drug class: Soluble Guanylate Cyclase (sGC) Stimulators
Therapeutic class: Cardiovascular Therapy Agents
Vericiguat, a soluble guanylate cyclase (sGC) stimulator, is a vasodilator.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for VERQUVO (vericiguat) have been approved by the FDA:
Indications:
Heart failure with reduced ejection fraction
Professional Synonyms:
CHF with reduced ejection fraction
Chronic heart failure with reduced ejection fraction
Systolic heart failure
Indications:
Heart failure with reduced ejection fraction
Professional Synonyms:
CHF with reduced ejection fraction
Chronic heart failure with reduced ejection fraction
Systolic heart failure
The following dosing information is available for VERQUVO (vericiguat):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VERQUVO 2.5 MG TABLET | Maintenance | Adults take 1 tablet (2.5 mg) by oral route once daily |
| VERQUVO 5 MG TABLET | Maintenance | Adults take 1 tablet (5 mg) by oral route once daily |
| VERQUVO 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
No generic dosing information available.
The following drug interaction information is available for VERQUVO (vericiguat):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Vericiguat/PDE Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Vericiguat stimulates the nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate (cGMP) pathway and also increases cGMP.(1) Aminophylline, avanafil, dipyridamole, sildenafil, tadalafil, theophylline, and vardenafil inhibit phosphodiesterase (PDE), which is responsible for the breakdown of cGMP.(1-6) CLINICAL EFFECTS: The concurrent use of PDE inhibitors and vericiguat potentiates the hypotensive effects of both agents, which may result in dizziness, syncope, heart attack, or stroke.(1) PREDISPOSING FACTORS: Plasma levels of the PDE type-5 inhibitors may be higher in the following patients: those older than 65, with hepatic impairment, or with severe renal impairment. This may increase the severity of the interaction. PATIENT MANAGEMENT: The manufacturer of vericiguat states that administration of vericiguat to patients receiving PDE inhibitors, including specific PDE-5 inhibitors (avanafil,(2) sildenafil,(3) tadalafil,(4,5) or vardenafil(6)) and nonspecific PDE inhibitors (aminophylline, dipyridamole, theophylline) is not recommended.(1) The manufacturers of the PDE-5 inhibitors state that concurrent use of guanylate cyclase stimulators is contraindicated.(2-6) DISCUSSION: Concomitant use of vericiguat 10 mg with single doses of sildenafil (25, 50, or 100 mg) was associated with additional seated BP reduction of up to 5.4 mm Hg (systolic/diastolic BP, MAP), compared to administration of vericiguat alone.(1) |
ADCIRCA, ALYQ, AMINOPHYLLINE, ASPIRIN-DIPYRIDAMOLE ER, AVANAFIL, CIALIS, DIPYRIDAMOLE, ELIXOPHYLLIN, ENTADFI, OPSYNVI, REVATIO, SILDENAFIL CITRATE, STENDRA, TADALAFIL, TADLIQ, THEO-24, THEOPHYLLINE, THEOPHYLLINE ANHYDROUS, THEOPHYLLINE ER, THEOPHYLLINE ETHYLENEDIAMINE, VARDENAFIL HCL, VIAGRA |
There are 0 moderate interactions.
The following contraindication information is available for VERQUVO (vericiguat):
Drug contraindication overview.
*Pregnancy. *Concomitant therapy with other soluble guanylate cyclase stimulators.
*Pregnancy. *Concomitant therapy with other soluble guanylate cyclase stimulators.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Pregnancy |
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for VERQUVO (vericiguat):
Adverse reaction overview.
The most common adverse reactions reported in >=5% of patients receiving vericiguat are hypotension and anemia.
The most common adverse reactions reported in >=5% of patients receiving vericiguat are hypotension and anemia.
There are 2 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anemia Hypotension |
None. |
| Rare/Very Rare |
|---|
| None. |
There are 0 less severe adverse reactions.
The following precautions are available for VERQUVO (vericiguat):
Safety and effectiveness of vericiguat have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Based on data from animal reproduction studies, vericiguat may cause embryo-fetal toxicity when administered to a pregnant woman and is contraindicated during pregnancy. There are no available data with vericiguat use in pregnant women. In animal reproduction studies, oral administration of vericiguat 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 an increased number of abortions and resorptions.
In a pre/postnatal toxicity study, vericiguat administered orally to rats during gestation through lactation caused maternal toxicity, which resulted in decreased pup body weight gain (dosage >=10 times the MRHD) and increased pup mortality (dosage 24 times the MRHD) during the preweaning period. (14C)-vericiguat was administered orally to pregnant rats at a dose of 3 mg/kg and vericiguat-related material was transferred across the placenta, with fetal plasma concentrations of approximately 67% maternal concentrations on gestation day 19. There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to vericiguat during pregnancy.
Healthcare providers should report any prenatal exposure to vericiguat by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
In a pre/postnatal toxicity study, vericiguat administered orally to rats during gestation through lactation caused maternal toxicity, which resulted in decreased pup body weight gain (dosage >=10 times the MRHD) and increased pup mortality (dosage 24 times the MRHD) during the preweaning period. (14C)-vericiguat was administered orally to pregnant rats at a dose of 3 mg/kg and vericiguat-related material was transferred across the placenta, with fetal plasma concentrations of approximately 67% maternal concentrations on gestation day 19. There is a Pregnancy Surveillance Program that monitors pregnancy outcomes in women exposed to vericiguat during pregnancy.
Healthcare providers should report any prenatal exposure to vericiguat by calling 1-877-888-4231 or at https://pregnancyreporting.verquvo-us.com.
There are no data on the presence of vericiguat in human milk, the effects on the breastfed infant, or the 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. Because of the potential for serious adverse reactions in breastfed infants from vericiguat, advise women not to breastfeed during treatment with vericiguat.
No dosage adjustment of vericiguat is required in geriatric patients. In the VICTORIA study, a total of 1,596 (63%) patients treated with vericiguat were 65 years of age and older, and 783 (31%) patients treated with vericiguat were 75 years of age and older. No overall differences in safety or efficacy of vericiguat were observed between patients 65 years of age and older compared to younger patients, but greater sensitivity of some older individuals cannot be ruled out.
The following prioritized warning is available for VERQUVO (vericiguat):
WARNING: Vericiguat must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication and for 1 month after treatment.
Female patients must use reliable birth control during treatment and for 1 month after the end of treatment. Ask your doctor which forms of birth control to use while taking this medication. Female patients must take a pregnancy test before starting treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.
WARNING: Vericiguat must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication and for 1 month after treatment.
Female patients must use reliable birth control during treatment and for 1 month after the end of treatment. Ask your doctor which forms of birth control to use while taking this medication. Female patients must take a pregnancy test before starting treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.
The following icd codes are available for VERQUVO (vericiguat)'s list of indications:
| heart failure with reduced ejection fraction | |
| I50.2 | Systolic (congestive) heart failure |
| I50.20 | Unspecified systolic (congestive) heart failure |
| I50.21 | Acute systolic (congestive) heart failure |
| I50.22 | Chronic systolic (congestive) heart failure |
| I50.23 | Acute on chronic systolic (congestive) heart failure |
| I50.4 | Combined systolic (congestive) and diastolic (congestive) heart failure |
| I50.40 | Unspecified combined systolic (congestive) and diastolic (congestive) heart failure |
| I50.41 | Acute combined systolic (congestive) and diastolic (congestive) heart failure |
| I50.42 | Chronic combined systolic (congestive) and diastolic (congestive) heart failure |
| I50.43 | Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure |
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