May 6, 2016
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Panretin

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Panretin




PATIENT INFORMATION

Panretin®
(alitretinoin) gel 0.1%
(For topical use only)

Patient's Instructions for Use

Your health care provider has prescribed Panretin® gel for the management of the Kaposi's sarcoma (KS) lesions on your skin. The following simple instructions will help you successfully begin and continue your treatment.

WARNINGS

DO NOT apply gel on or near mucosal surfaces of the body such as eyes, nostrils, mouth, lips, vagina, tip of the penis, rectum or anus.

DO NOT use insect repellents containing DEET (N,N-diethyl-m-toluamide) or other products containing DEET while using Panretin® gel.

Keep Out of Reach of Children.

Product contains alcohol and should be kept away from open flame.

DO NOT use Panretin® gel if you are pregnant or breastfeeding. Precautions should be taken to avoid becoming pregnant while using Panretin® gel. If you are pregnant, thinking of becoming pregnant, or breastfeeding, speak with your health care provider for more information.

Topical Panretin® gel does not treat lung or intestinal Kaposi's sarcoma.

Topical Panretin® gel does not prevent the appearance of new KS lesions or the increased growth of KS lesions not treated with Panretin® gel.

Topical Panretin® gel does not treat extremity swelling associated with KS. It is important to understand that KS lesions can appear and affect other parts of your body, including internal organs (e.g., lungs and intestines). You should regularly consult your health care provider about the status of your KS disease, especially if you note changes.

HOW TO APPLY

Apply Panretin® gel to your KS lesions using a clean finger. Place a generous coating of gel over the entire surface of each lesion that you want to treat. It is not necessary to physically rub the gel into the lesion. You should make every effort not to apply gel to the healthy skin around the lesion. The extra effort you take in carefully applying the gel only to the area of the KS lesion will help to lessen any irritation or redness which may occur. Proper application should leave some gel visible on the surface of the lesion when you are finished with the application.

Immediately following application, wipe the finger(s) you have used to apply the gel with a disposable tissue and wash your hands using soap and water.

Allow the gel to dry before covering a treated area with clothing. This will usually take from three (3) to five (5) minutes.

A mild soap is recommended when bathing or showering.

WHEN TO APPLY

Panretin® gel should be applied at an initial frequency of two (2) times daily. Your health care provider may instruct you to apply Panretin® gel at a different frequency (up to four [4] times daily). Applications should be spaced as evenly as possible throughout the day. If you apply Panretin® gel after your shower or bath, you should wait 20 minutes before application.

YOU SHOULD AVOID…

You should avoid applying the gel to areas of healthy skin around a KS lesion. Exposure of healthy skin to Panretin® gel may cause unnecessary irritation or redness.

You should avoid showering, bathing, or swimming until at least three (3) hours after any application, if possible.

You should avoid covering the KS lesions treated with gel with any bandage or material other than loose clothing.

You should avoid prolonged exposure of the treated area to sunlight or other ultraviolet (UV) light (such as tanning lamps).

You should avoid the use of other topical products on your treated KS lesions. Mineral oil may be used between Panretin® gel applications in order to help prevent excessive dryness or itching. However, mineral oil should not be applied for at least two (2) hours before or after the application of Panretin® gel.

You should avoid scratching the treated areas.

WHAT TO EXPECT

Do not be discouraged if you do not see immediate improvement.

Do not stop treatment at the first sign of improvement.

While using Panretin® gel, you may experience some local effects such as redness, discomfort, itching, and skin peeling or flaking at the area of application. Other possible local skin effects include: rawness, surface or deep cracking, scabbing, crusting, drainage, oozing, or infection. Should these or other effects become troublesome to you, consult your health care provider. He or she can provide information on how to manage these effects.

HOW QUICKLY CAN I EXPECT PANRETIN® GEL TO WORK?

Be patient. Panretin® gel takes time to work, up to 14 weeks or more of treatment. In clinical trials, few patients experienced the onset of response as early as two (2) weeks; most patients who responded required at least four (4) to eight (8) weeks of treatment, and some patients did not experience significant improvement until 14 or more weeks of treatment. Continue to use Panretin® gel as instructed by your health care provider.

OTHER INFORMATION

The opening of the Panretin® gel tube is covered by a metal safety seal. If this seal has been punctured or is not visible when you open the package, DO NOT USE and promptly return the product to your pharmacy or place of purchase.

To open, use the pointed portion of the cap to puncture the metal safety seal.

Always use the cap to close the tube tightly after each use.

Store at room temperature. Keep away from heat.

IF YOU HAVE QUESTIONS…

If you have any questions about your treatment, talk with your health care provider.

Last reviewed on RxList: 3/14/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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