Brand Name

    US Brand Name

    Verquvo


    Description

    Vericiguat is used to reduce the risk of dying and the need to be hospitalized in patients who have chronic heart failure, who 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.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of vericiguat in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vericiguat in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, which may require caution in patients receiving vericiguat.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Avanafil
    • Riociguat
    • Tadalafil

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Sildenafil
    • Vardenafil

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


    Proper Use

    Take this medicine as exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

    This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    It is best to take this medicine with food.

    If you have trouble swallowing the tablet, you may crush and mix with water and take it right away.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (tablets):
      • For chronic heart failure:
        • Adults—At first, 2.5 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 mg once a day.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.

    Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant while you are using this medicine and for at least 1 month after your last dose. Tell your doctor right away if you think you have become pregnant.

    Do not use this medicine together with another soluble guanylate cyclase (sGC) stimulator. Do not use this medicine together with medicine to treat erectile dysfunction (eg, sildenafil). Using these medicines together may cause hypotension (low blood pressure).


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    More common

    • Blurred vision
    • confusion
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • pale skin
    • sweating
    • trouble breathing
    • unusual bleeding or bruising
    • unusual tiredness or weakness

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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