In the U.S.—

• Antineoplastic

Alitretinoin ( al-i-TRET-i-no-in ) 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, in the following dosage form:

Topical
• Gel (U.S.)

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 alitretinoin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic 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, this medicine may be needed in serious diseases or other situations that threaten the mother's life. Be sure you have discussed this with your doctor. Discuss these possible effects with your doctor.

Breast-feeding—It is not known whether this medicine passes into breast 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 adult patients, and there is no specific information comparing the use of alitretinoin in children with use in other age groups.

Older adults—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.

Other medicines—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 alitretinoin, it is especially important that your doctor and pharmacist know if you are using the following:

• DEET-containing insect repellants—Concurrent use with products containing DEET may increase DEET side effects

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

Avoid the use of occlusive dressings

Dosing—

Follow your doctor's orders or the directions on the label. The following information includes only the average doses of alitretinoin. If your dose is different, 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 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, use 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—

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 your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

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

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 
  
  

Other 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. However, check with your 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. If you notice any other effects, check with your doctor.