What is Panretin?
Panretin is a gel containing the active ingredient alitretinoin (0.1%).
What is Panretin used for?
Panretin gel is indicated for the treatment of skin lesions (swelling or swelling) in patients with Kaposi's sarcoma, a type of skin cancer and AIDS patients. Panretin is used in cases where:
• the lesions are not ulcerated or lymphedematous (the skin is not broken and the lesions are not swollen with liquids);
• the lesions do not respond to the antiretroviral therapy to which the patient has been subjected;
• radiotherapy or chemotherapy are not indicated;
• the patient does not need the treatment envisaged for visceral Kaposi sarcoma (internal).
The medicine can only be obtained with a prescription.
How is Panretin used?
Treatment with Panretin should only be started and followed by specialist physicians experienced in the treatment of patients with Kaposi's sarcoma. Panretin is applied twice a day to skin lesions, avoiding use on healthy skin and using a sufficient amount of product to cover each lesion with a generous layer. The gel should be allowed to dry for 3-5 minutes before covering the part with a garment. The frequency of applications can be increased up to 3-4 times a day, depending on the tolerance to the treatment of individual lesions. Generally Panretin is applied to the lesions initially for up to 12 weeks. Treatment may continue beyond this period only in the case of injuries that have responded to treatment. Panretin is indicated in male patients; information on use in women is very scarce, as women rarely contract Kaposi's sarcoma.
How does Panretin work?
The active substance in Panretin, alitretinoin, is an anticancer agent that belongs to the group of retinoids, substances derived from vitamin A. The exact mechanism of action of alitretinoin in Kaposi sarcoma is not yet known.
How has Panretin been studied?
Panretin has been studied in two 12-week studies involving patients with Kaposi's sarcoma, out of a total of 402 subjects, in whom the effectiveness of Panretin was compared to that of placebo (a substance without effects on the body; in this case, the gel lacking the active ingredient). The main measure of effectiveness was the general response to treatment, ie the response of the treated lesions (the area affected by the lesion was reduced, the swelling was attenuated).
What benefit has Panretin shown during the studies?
In both studies Panretin was more effective than placebo, with a general response to treatment in 35% and 37% of Panretin-treated patients compared to 18% and 7% of placebo-treated subjects.
What is the risk associated with Panretin?
The most frequently reported side effects with Panretin (seen in more than 1 in 10 patients) are erythema (redness, crusted concretions, irritation), itching, skin disorders (cracking, scales, crusting, secretion, transudation) and pain ( burning, irritation). For the full list of all side effects reported with Panretin, see the Package Leaflet.
Panretin must not be used in people who may be hypersensitive (allergic) to retinoids in general, to alitretinoin or to any of the other substances. Panretin should also not be used if you are pregnant or breastfeeding. Panretin is also not indicated for the treatment of lesions near other skin disorders.
Why has Panretin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Panretin's benefits are greater than its risks for the local treatment of skin lesions in patients with Kaposi sarcoma associated with AIDS and therefore recommended that an authorization be issued marketing of the product.
Other information on Panretin:
On 11 October 2000, the European Commission issued a marketing authorization for Panretin, valid throughout the European Union. The marketing authorization was renewed on 11 October 2005. The marketing authorization holder is Eisai Ltd.
The full EPAR for Panretin can be found here.
Last update of this summary: 04-2007
