Panretin (Alitretinoin) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Panretin

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Panretin

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SIDE EFFECTS

The safety of Panretin® (alitretinoin) gel has been assessed in clinical studies of 385 patients with AIDS-related KS. Adverse events associated with the use of Panretin® (alitretinoin) 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® (alitretinoin) 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® (alitretinoin) 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® (alitretinoin) Gel or Vehicle Control

Adverse Event Term	Study 1		Study 2
Adverse Event Term	Panretin® (alitretinoin) Gel N=134 Pts .%	Vehicle Gel N=134 Pts. %	Panretin® (alitretinoin) 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, pruritis ⁴Flaking, peeling, desquamation, exfoliation ⁵Excoriation, cracking, scab, crusting, drainage, eschar, fissure or oozing ⁶Stinging, tingling ⁷Edema, swelling, inflammation

DRUG INTERACTIONS

Patients who are applying Panretin® (alitretinoin) gel should not concurrently use products that contain DEET (N,N-diethyl-m-toluamide), a common component of insect repellent products. Animal toxicology studies showed increased DEET toxicity when DEET was included as part of the formulation.

Although there was no clinical evidence in the vehicle-controlled studies of drug interactions with systemic antiretroviral agents, including protease inhibitors, macrolide antibiotics, and azole antifungals, the effect of Panretin® (alitretinoin) gel on the steady-state concentrations of these drugs is not known. No drug interaction data are available on concomitant administration of Panretin® (alitretinoin) gel and systemic anti-KS agents.