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USP DI Vol. II - ALITRETINOIN (Topical)

ALITRETINOIN (Topical)?


Some commonly used brand names are:

In the U.S.?

  • Panretin Gel

? Not commercially available in Canada.


Category

  • Antineoplastic

Description

Alitretinoin ( al-i-TRET-i-no-in) is used as a topical treatment for cutaneous AIDS-relatedKaposi's sarcoma in cases when there is no need for oral or intravenous medication.

This medicine is available only with your doctor's prescription, in thefollowing dosage form:

    Topical
  • Gel (U.S.)


Before Using This Medicine

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

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to a retinoid (vitamin A) drug product.

Pregnancy?Alitretinoin has not been studied in pregnant women. Alitretinoin has been shown to cause birth defects in animals. However, thismedicine may be needed in serious diseases or other situations that threatenthe mother's life. Be sure you have discussed this with your doctor. Discussthese possible effects with your doctor.

Breast-feeding?It is not known whether this medicine passes intobreast milk. However, alitretinoin is not recommended during breast-feeding,because it may cause unwanted effects in nursing babies.

Children?Studies of this medicine have been done only in adultpatients, and there is no specific information comparing the use of alitretinoinin children with use in other age groups.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose or other precautions may be necessary. When you are takingalitretinoin, it is especially important that your doctor and pharmacist know if you are using the following:

  • DEET-containing insect repellants?Concurrent use with productscontaining DEET may increase DEET side effects

Other medical problems?The presence of other medicalproblems may affect the use of alitretinoin. Make sure to tell your doctorif you have any other medical problems, especially

  • Cutaneous T-cell lymphoma?May be more likely to experienceside effects of alitretinoin gel.


Proper Use of This Medicine

Avoid theuse of occlusive dressings

Dosing?Follow your doctor's ordersor the directions on the label. The following information includesonly the average doses of alitretinoin. If your dose isdifferent, do not change it unless your doctor tells you to do so.

  • For topical dosage form (gel):
    • For cutaneous Kaposi's sarcoma:
      • Adults?Apply a generous amount to the affected area of theskin two times day, or as directed by your doctor, and allow to dry for threeto 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, use it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat.
  • Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits to make sure that this medicine is working properlyand to check for unwanted effects.

This medicine increases the sensitivity of the treated areas of your skinto 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 surroundingthe lesions or to mucous membranes


Side Effects of This Medicine

Along with its neededeffects, a medicine may cause some unwanted effects. Although not all of theseside 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 sideeffects 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

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:

    More common

      Itching; rash

Less common

Increased sensitivity to the sun

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.


Revised: 12/02/1999