Verquvo (vericiguat)

Verquvo (vericiguat) is a prescription medicine used in adults who are having symptoms of their chronic (long-lasting) heart failure, who have had a recent hospitalization or the need to receive intravenous (IV) medicines and have an ejection fraction (amount of blood pumped with each heartbeat) of less than 45 percent:

• to reduce the risk of dying and
• to reduce the need to be hospitalized

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.

The most common side effects of Verquvo include:

• low blood pressure
• low red blood cells (anemia)

These are not all the possible side effects of Verquvo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• 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.

Pregnancy Testing In Females Of Reproductive Potential

• Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with Verquvo.

Other Soluble Guanylate Cyclase Stimulators

• Verquvo is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators.

PDE-5 Inhibitors

• Concomitant use of Verquvo with PDE-5 inhibitors is not recommended because of the potential for hypotension.

Verquvo may cause birth defects if taken during pregnancy.

• Females must not be pregnant when they start taking Verquvo.
• Females who are able to get pregnant:
  • Your healthcare provider will do a pregnancy test to make sure that you are not pregnant before you start taking Verquvo.
  • You must use effective forms of birth control during treatment and for 1 month after you stop treatment with Verquvo. Talk to your healthcare provider about forms of birth control that you may use to prevent pregnancy during treatment with Verquvo.
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Verquvo.

Do not take Verquvo if you:

• are taking another medicine called a soluble guanylate cyclase stimulator (sGC). Ask your healthcare provider if you are not sure if you are taking an sGC medicine.
• are pregnant.

Before you take Verquvo, tell your healthcare provider about all your medical conditions, including if you:

• are breastfeeding or plan to breastfeed. It is not known if Verquvo passes into your breast milk. Do not breastfeed if you take Verquvo. Talk with your healthcare provider about the best way to feed your baby if you take Verquvo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how Verquvo works.