1.1 Kaposi’s Sarcoma

PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS).

Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies (14.1)].

PANRETIN GEL is for topical use only.
Do not use occlusive dressings with PANRETIN GEL.

• Apply PANRETIN GEL twice daily to coat the entire cutaneous Kaposi sarcoma lesions.
• Gradually increase the application frequency up to four (4) times a day as tolerated.
• Continue PANRETIN GEL as long as patient is deriving benefit.
• Reduce application frequency for application site toxicity. Interrupt treatment for severe irritation; may resume at a reduced application frequency once symptoms improve.
• Avoid application of gel to normal skin and do not apply on or near mucosal surfaces.
• Wash hands after application unless gel is applied to Kaposi sarcoma lesions on the hands.
• Allow gel to dry for three to five minutes before covering with clothing.

Topical Gel: 0.1% alitretinoin (clear yellow gel) in a 60-gram tube.

PANRETIN GEL is contraindicated in patients with a known hypersensitivity to retinoids or to any of the ingredients of the product.

The following clinically significant adverse reactions are described elsewhere in the labeling:
• Photosensitivity [see Warnings and Precautions (5.2)]

PANRETIN GEL is a retinoid. PANRETIN GEL 0.1% contains alitretinoin and is intended for topical application only. The chemical name is (2E,4E,6Z,8E)-3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid, also known as 9-cis-retinoic acid. Chemically, alitretinoin is related to vitamin A. It is a yellow powder with a molecular weight of 300.44 and a molecular formula of C20H28O2. It is slightly soluble in ethanol (7.01 mg/g at 25℃) and insoluble in water. The structural formula of alitretinoin is as follows:

PANRETIN GEL is a clear, yellow gel containing 0.1% (w/w) alitretinoin. Each gram of PANRETIN GEL contains 1 mg alitretinoin. PANRETIN GEL contains the following inactive ingredients: butylated hydroxytoluene NF, dehydrated alcohol USP 92%, hydroxypropyl cellulose NF, and polyethylene glycol 400 NF.

14.1 Kaposi’s Sarcoma

PANRETIN GEL was evaluated in two multicenter, randomized, double-blind, vehicle-controlled studies in adult patients with cutaneous lesions of AIDS-related KS. In both studies the primary efficacy objective was the patients’ cutaneous KS tumor response rate through 12 weeks of study drug treatment which was assessed by evaluating from 3 to 8 KS index lesions according to the modified AIDS Clinical Trials Group (ACTG) response criteria as applied to topical therapy (i.e., evaluation of height and area reductions of the index lesions only; progressive disease in non-index lesions and new lesions were not considered progressive disease; progressive disease was scored only in the treated index lesions). A global evaluation by physicians was also carried out. It considered all the patient’s treated lesions (index and other) compared to baseline. In this evaluation, patients with at least a 50% improvement in the KS lesions were considered responders. In addition, photographs of lesions in patients considered responders by the modified ACTG criteria were examined by the FDA for a cosmetically beneficial response, defined as at least a 50% improvement in appearance compared to baseline, considering both the KS lesions and dermal toxicity at the lesion site, in at least 50% of the index lesions and maintained for at least 3 weeks. Visceral disease was not monitored in these trials and the appearance of new KS lesions was not considered part of the response assessment.

In Trial 1, a total of 268 patients were entered from centers in the U.S. and Canada. Patients were treated topically three to four times a day with either PANRETIN GEL or a matching vehicle gel for a minimum of 12 weeks, followed by an open-label phase in patients who had not yet progressed on PANRETIN GEL. Median age of patients was 39 years, 99% were men, 75% were White, 16% Hispanic, and 7% Black. Fifty-seven percent of patients had a CD4+ lymphocyte count <200/mm3 and 36% had CD4+ lymphocyte count less than 100/mm3; 12% had visceral KS. Responses during the double-blind phase are shown in Table 2. New lesions in untreated areas were seen in about 50% of patients.

Trial 2 was an international study with a planned enrollment of 270 patients. Patients were treated topically twice a day with PANRETIN GEL or a matching vehicle for 12 weeks. The study was stopped early because of positive-interim results in the initial 82 patients. Median age of patients was 36 years for PANRETIN-GEL and 39 years for matching vehicle; all patients were men; 89% White; 5% Hispanic, and 4% Black; 67% had a CD4+ lymphocyte count ≤200/mm3 and 39% had CD4+ lymphocyte count ≤100/mm3; and 16% had visceral KS.

Results of the study are shown in Table 2. Responses to PANRETIN GEL were seen both in previously untreated patients and in patients with prior systemic and/or topical KS treatment.

Table 2:  Response Rates

*All responses were partial responses except 1% complete response for modified ACTG response in Trial 1. 

In the clinical trials, the cumulative percentage of patients who experienced a response was less than 1% at 2 weeks, 10% at 4 weeks, and 28% at 8 weeks. Photographs of some patients revealed an erythematous and edematous response, leading to a cosmetically mixed outcome.

PANRETIN GEL is a clear yellow gel and is supplied in a 60-gram tubes containing 0.1% alitretinoin.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
PANRETIN GEL is flammable; keep away from heat or flame.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Embryo-Fetal Toxicity

Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform females of the risk to a fetus and potential loss of pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment and for 1 week after the last dose of PANRETIN GEL [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week following the last dose of PANRETIN GEL [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3)].

Lactation
Advise patients not to breastfeed during treatment with PANRETIN GEL and for 1 week after the last dose of PANRETIN GEL [see Use in Specific Populations (8.2)].

Photosensitivity
Advice patients that PANRETIN GEL can cause photosensitivity and to avoid sunlight and sunlamps and use measures such as protective clothing in PANRETIN-applied areas [see Warnings and Precautions (5.2)].

Toxicity with DEET-Containing Products
Advise patients to avoid DEET-containing products such as insect repellant while using PANRETIN GEL [see Warnings and Precautions (5.3)].

Manufactured for:
Advanz Pharma (US) Corp.
Bannockburn IL, 60015
PANRETIN® is a registered trademark of Mercury Pharma Group Limited. Distributed by Advanz Pharma (US) Corp. under license

                                                                                                                                                                                                            Revised: 11/2025

NDC 59212-601-22
 Panretin® gel
 (alitretinoin) 0.1%