Alitretinoin (topical route)


    Brand Name

    US Brand Name

    Panretin


    Description

    Alitretinoin is used as a topical treatment for cutaneous AIDS-related Kaposi's sarcoma in cases when there is no need for oral or intravenous medication.

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

    This product is available in the following dosage forms:

    • Gel/Jelly

    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

    Studies of this medicine have been done only in adult patients, and there is no specific information comparing the use of alitretinoin in children with use in other age groups.

    Geriatric

    Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of alitretinoin in the elderly with use in other age groups.

    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. 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.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Cutaneous T-cell lymphoma—May be more likely to experience side effects of alitretinoin gel.

    Proper Use

    Avoid the use of occlusive dressings

    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 (gel):
      • For cutaneous Kaposi's sarcoma:
        • Adults—Apply a generous amount to the affected area of the skin two times day, or as directed by your doctor, and allow to dry for three to five minutes before covering with clothing.
        • 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.


    Precautions

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

    This medicine increases the sensitivity of the treated areas of your skin to sunlight or sun lamps. Therefore, exposure to the sun, even through window glass or on a cloudy day, could cause a serious burn.

    Avoid application of the gel to normal skin surrounding the lesions or to mucous membranes


    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 as soon as possible if any of the following side effects occur:

    More common

    • Abrasion of skin
    • blisters on skin
    • burning pain
    • cracking, crusting, drainage, or oozing of the skin
    • groove in the skin
    • peeling of skin
    • severe rash
    • skin redness
    • sloughing of skin
    • swelling at the site of application

    Less common

    • Stinging or tingling of skin

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Itching
    • rash

    Less common

    • Increased sensitivity to the sun

    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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