Frequently asked questions about VERQUVO® (vericiguat)
For answers to questions you may have, select any of the topics below. To see a complete list of FAQs, scroll down.
What is the indication and usage for VERQUVO?
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%.
What is the Selected Safety Information for VERQUVO?
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.
What is the recommended dosing for VERQUVO?
The recommended starting dose of VERQUVO is 2.5 mg orally once daily with food. Double the dose of VERQUVO approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the patient. For patients who are unable to swallow whole tablets, VERQUVO may be crushed and mixed with water immediately before administration.
What are the contraindications for VERQUVO?
- Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.
- Pregnancy
What are the drug interactions listed for VERQUVO?
VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators [see Contraindications above].
Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension.
What are the most common adverse reactions for VERQUVO?
The most common adverse reactions reported in ≥5% are hypotension and anemia.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
VERQUVO was evaluated in VICTORIA, which included 2,519 patients treated with VERQUVO (up to 10 mg once daily). The mean duration of VERQUVO exposure was 1 year, and the maximum duration was 2.6 years.
Table 1 lists adverse drug reactions occurring more commonly with VERQUVO than placebo and in ≥5% of patients treated with VERQUVO in VICTORIA.
Table 1: adverse drug reactions occurring with VERQUVO in VICTORIA
| Adverse drug reaction | VERQUVO % (N=2,519) |
|---|---|
| Hypotension | 16 |
| Anemia | 10 |
| Adverse drug reaction | Placebo % (N=2,515) |
|---|---|
| Hypotension | 15 |
| Anemia | 7 |
Is there a coupon for VERQUVO?
Yes. Your eligible, privately insured patients may save on their out-of-pocket prescription costs for VERQUVO, paying as little as $10 per prescription on each of up to 13 qualifying prescriptions. Maximum program savings is $3,500 per patient.
Your patients can visit verquvo-us.com to request a coupon, and if eligible, activate and bring it to their pharmacy along with their prescription.
Not valid for patients who are uninsured or patients with Medicare or other Government Program insurance. Not all patients are eligible. Certain restrictions apply. Tell your eligible, privately insured patients to visit verquvo-us.com to review the Terms and Conditions.
Also, eligible health care professionals may request coupons for VERQUVO for use with their eligible, privately insured patients.
What is the mechanism of action for VERQUVO?
Vericiguat is a stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, 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.
When did VERQUVO receive FDA approval?
VERQUVO received FDA approval in January 2021.
Where can patients get information on VERQUVO?
Your patients can visit https://www.verquvo-us.com/ to find product information and resources.