Panretin
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Panretin
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 | ||
| 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 |
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Read the Panretin (alitretinoin) Side Effects Center for a complete guide to possible side effects »
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.
Drug/Laboratory Test Interactions
No interference with laboratory tests has been observed.
Last reviewed on RxList: 11/17/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Panretin Information
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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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