Alitretinoin Topical gel
What is this medicine?
ALITRETINOIN (a li TRE ti noyn) is a naturally occurring form of vitamin A. It is used on the skin to treat Kaposi's sarcoma lesions. This gel does not treat other forms of Kaposi's sarcoma or prevent new skin lesions.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an unusual or allergic reaction to alitretinoin, vitamin A, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Open the tube by puncturing the metal seal with the pointed portion of the cap. Do not use if the metal seal has been punctured or is not present when you first open the package.
This medicine is for external use only. Do not take by mouth. Follow the directions on the prescription label. Make sure the skin is clean and dry. Wait 20 minutes after a shower or bath before using. Apply a generous coating to the lesions. Do not rub the gel into the lesion. Allow the gel to dry for 3 to 5 minutes before covering with clothing. Try to avoid contact of the gel with unaffected skin around the lesions. This will decrease irritation and redness. Do not cover lesions treated with the gel with any bandage or material other than loose clothing. Wipe your finger(s) you have used to apply the gel with a tissue and wash your hands using soap and water. Wait at least 3 hours after any application before showering, bathing, or swimming. Do not get this medicine in your eyes. If you do, rinse out with plenty of cool tap water. Do not use your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
Apply as soon as you remember. If it is almost time for your next dose, apply only that dose. Do not use extra doses, or use for a longer period of time than directed by your doctor or health care professional.
What may interact with this medicine?
insect repellents that contain DEET
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
It may take a few weeks before you see the full benefit. Kaposi's sarcoma lesions can affect other parts of your body including the lungs and intestines. You should continue to visit your doctor or health care professional on a regular basis to monitor your progress.
Do not use this medicine if you are pregnant or breast-feeding. Precautions should be taken to avoid becoming pregnant while using this medicine.
Avoid the use of other skincare products on the treated Kaposi's sarcoma lesions. Mineral oil may be used in between applications in order to prevent too much dryness or itching. Do not apply mineral oil for at least 2 hours before or after applying this gel. Try not to scratch treated areas.
This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
signs of infection such as drainage, swelling, or pus formation
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
burning, itching, crusting, or cracking of the treated areas
increased sensitivity to the sun
red, inflamed, and irritated skin, the skin may peel after a few days
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Keep away from heat and flame. Protect from light.
March 21, 2017
U.S. FDA-approved Package Insert