Tapinarof (topical application route)


    Brand Name

    US Brand Name

    Vtama


    Description

    Tapinarof topical cream is used to treat plaque psoriasis, which is a form of skin disease with red patches and white scales that do not go away.

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

    This product is available in the following dosage forms:

    • Cream

    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 on the relationship of age to the effects of tapinarof topical cream have not been performed 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 tapinarof topical cream in the elderly.

    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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    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

    It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

    This medicine should only be used on the skin. Do not get it into your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away.

    This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

    To use:

    • Wash your hands with soap and water before and after you use this medicine, unless you are using it to treat your hands.
    • Apply a thin layer to the affected area of the skin. Rub it in gently.

    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 topical dosage form (cream):
      • For plaque psoriasis:
        • Adults—Apply to the affected area of the skin once a day.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, apply 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.

    Storage

    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.

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

    Do not expose the cream to excessive heat.


    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 any unwanted effects.

    If your condition does not improve or if it becomes worse, check with your doctor.


    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

    • Body aches and pain
    • blistering, burning, crusting, dryness, or flaking of the skin
    • burning, itching, and pain in hairy areas
    • chills
    • cough
    • difficulty in breathing
    • ear congestion
    • fever
    • headache
    • itching, scaling, severe redness, soreness, or swelling of the skin
    • loss of voice
    • muscle aches and pains
    • pus at the root of hair
    • shivering
    • sneezing
    • sore throat
    • stuffy or runny nose
    • sweating
    • unusual tiredness or weakness

    Less common

    • General feeling of discomfort or illness
    • itching or pain of the genital area
    • joint pain
    • shivering
    • sweating
    • trouble sleeping
    • vomiting

    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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