Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Eisai GmbH, Lyoner Straße 36, 60528, Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net
Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDSrelated Kaposi’s sarcoma (KS) when:
Panretin therapy should only be initiated and maintained by specialist physicians experienced in the treatment of patients with KS.
Patients should apply Panretin to cutaneous KS lesions using sufficient gel so as to cover each lesion with a generous coating.
Patients should initially apply Panretin twice a day to cutaneous KS lesions. The application frequency can be increased stepwise to three or four times a day according to individual lesion tolerance, allowing no less than two weeks between dose increases. The frequency of application should be adjusted for each lesion independently. If application site toxicity occurs, the application frequency can be reduced as described below. There are no data on the efficacy of Panretin applied less frequently than twice daily.
Local dermal irritation may be graded according to the five-point scale shown in Table 1. Guidelines for treatment adjustments necessitated by local dermal treatment-related toxicity are specified in Table 2.
Table 1. Grading of local dermal irritation:
| GRADE | DEFINING CLINICAL SIGNS |
|---|---|
| 0 = No reaction | None |
| 1 = Mild | Definite pink to red coloration |
| 2 = Moderate | Increased redness, possible oedema |
| 3 = Severe | Very red, with oedema, with or without vesiculation |
| 4 = Very severe | Deep red, swelling and oedema with or without signs of bullae formation and necrosis |
Table 2. Adjustment guidelines for treatment-limiting toxicity:
| LOCAL DERMAL IRRITATION (Graded per Table 1) | TREATMENT ADJUSTMENTS |
|---|---|
| Grade 0, 1 or 2 | No action required except continued monitoring. |
| Grade 3 | Treatment frequency for that lesion should be reduced or suspended. When dermal irritation improves to Grade 0 or 1, treatment may be restarted at twice daily, increasing every two weeks as tolerated. |
| Grade 4 | As for Grade 3 irritation. However, treatment should not be restarted if Grade 4 toxicity occurred at an application frequency of less than twice a day. |
It is recommended that Panretin should be applied to lesions for an initial period of up to 12 weeks. Treatment of lesions that have not shown a decrease in area and/or height by week 12 should be discontinued.
For those lesions that have shown a decrease in height and/or area by week 12, applications may be continued providing that there is continued improvement or at least maintenance of the response and that the product continues to be tolerated.
Treatment of any lesion that has fully resolved on clinical assessment should be discontinued.
Patients should wash their hands before and after applications; it is not necessary to wear gloves. The gel must be allowed to dry for three to five minutes before covering with clothing. Occlusive dressings should be avoided.
Care must be taken to avoid application of the gel to normal skin surrounding the lesions.
Gel should not be applied on or near eyes or mucosal surfaces of the body. Showering, bathing, or swimming for at least three hours after any application should be avoided.
Safety and effectiveness in women have not been established because of the paucity of clinical data. AIDS-related Kaposi’s sarcoma is infrequent in women.
The safety and efficacy of Panretin gel in children under 18 years has not been established.
No data are available.
Panretin is not approved for use in children and adolescents under 18 years of age.
There are no specific recommendations for use in elderly men (above 65 years of age). AIDSrelated Kaposi’s sarcoma is infrequent in this population.
There are no data regarding the use of Panretin gel in patients with renal insufficiency or liver disease. Pharmacokinetic studies indicate that the range and frequency of detection of quantifiable 9-cis-retinoic acid plasma concentrations in patients with KS after application of the medicinal product were comparable to the range and frequency of detection of quantifiable plasma concentrations of circulating, naturally-occurring 9-cis-retinoic acid in untreated individuals (see section 5.2). On a theoretical basis, no dose adjustment is necessary in patients with renal insufficiency or liver disease, but these patients should be closely monitored and treatment frequency reduced, or withdrawn, if they experience adverse effects.
No case of overdose has been reported.
Systemic toxicity following acute overdose with topical application of Panretin gel is unlikely.
Unopened: 3 years.
In-use: Any remaining tube should be discarded 90 days after first opening.
Do not store above 25°C.
Store in the original container in order to protect from light.
Keep the container tightly closed.
After opening the tube for application, the tube cap must be replaced and closed tightly to provide an airtight seal. Opened tubes of Panretin gel must not be stored above 25°C, and should be protected from exposure to strong light and heat (e.g., direct sunlight).
Panretin gel is supplied in a multi-use 60 g epoxy-lined aluminium tube.
Each carton contains one tube of gel.
Any unused product or waste material should be disposed of in accordance with local requirements.
Panretin gel contains alcohol, keep away from naked flame.
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