Panretin

What Is Panretin?

Panretin (alitretinoin) Gel 0.1% is a topical (for the skin) retinoid used to treat skin lesions caused by AIDS-related Kaposi's sarcoma.

What Are Side Effects of Panretin?

Serious side effects are not expected with Panretin Gel.

Common side effects of Panretin Gel include redness, rash, pain, burning, itching, stinging, tingling, irritation, warmth, peeling, swelling or inflammation, numbness, cracking, crusting, scabbing, or drainage at the application site.

Dosage for Panretin

Panretin gel should initially be applied two (2) times a day to cutaneous KS lesions. A sufficient dose of gel should be applied to cover the lesion with a generous coating. Panretin may interact with products that contain DEET (N, N-diethyl-m-toluamide), a common component of insect repellent products. Tell your doctor all medications and supplements you use.

Panretin During Pregnancy and Breastfeeding

Panretin is not recommended for use during pregnancy. Consult your doctor. It is unknown if this drug passes into breast milk. Because of possible risk to the infant, breastfeeding is not recommended while using Panretin.

Additional Information

Our Panretin (alitretinoin) Gel 0.1% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Panretin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe redness or swelling of treated skin areas;
• peeling or scaly skin;
• scabbing or crusting; or
• blistering or oozing of treated skin.

Common side effects may include:

• numbness or tingling;
• dryness or cracking of the skin; or
• mild itching, burning, or other skin irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Panretin (Alitretinoin)

 

Panretin Professional Information

SIDE EFFECTS

The safety of Panretin® gel has been assessed in clinical studies of 385 patients with AIDS-related KS. Adverse events associated with the use of Panretin® gel in patients with AIDS-related KS occurred almost exclusively at the site of application. The dermal toxicity begins as erythema; with continued application of Panretin® gel, erythema may increase and edema may develop. Dermal toxicity may become treatment-limiting, with intense erythema, edema, and vesiculation. Usually, however, adverse events are mild to moderate in severity; they led to withdrawal from the study in only 7% of the patients. Severe local (application site) skin adverse events occurred in about 10% of patients in the U.S. study (versus 0% in the vehicle control). Table 2 lists the adverse events that occurred at the application site with an incidence of at least 5% during the double-blind phase in the Panretin® gel-treated group and in the vehicle control group in either of the two controlled studies. Adverse events were reported at other sites but generally were similar in the two groups.

TABLE 2: Adverse Events with an Incidence of at Least 5% at the Application Site in Either Controlled Study in Patients Receiving Panretin® Gel or Vehicle Control

Adverse Event Term	Study 1		Study 2
	Panretin® Gel N=134 Pts. %	Vehicle Gel N=134 Pts. %	Panretin® Gel N=36 Pts. %	Vehicle Gel N=46 Pts. %
Rash1	77	11	25	4
Pain2	34	7	0	4
Pruritus3	11	4	8	4
Exfoliative dermatitis4	9	2	3	0
Skin disorder5	8	1	0	0
Paresthesia6	3	0	22	7
Edema7	8	3	3	0
Includes Investigator terms: 1Erythema, scaling, irritation, redness, rash, dermatitis 2Burning, pain 3Itching, pruritus 4Flaking, peeling, desquamation, exfoliation 5Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing 6Stinging, tingling 7Edema, swelling, inflammation

Read the entire FDA prescribing information for Panretin (Alitretinoin)