PANRETIN Gel Ref.[6133] Active ingredients: Alitretinoin

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Eisai GmbH, Lyoner StraรŸe 36, 60528, Frankfurt am Main, Germany, E-mail: medinfo_de@eisai.net

Therapeutic indications

Panretin gel is indicated for the topical treatment of cutaneous lesions in patients with AIDSrelated Kaposi’s sarcoma (KS) when:

  • lesions are not ulcerated or lymphoedematous
  • treatment of visceral KS is not required
  • lesions are not responding to systemic antiretroviral therapy
  • radiotherapy or chemotherapy are not appropriate

Posology and method of administration

Posology

Panretin therapy should only be initiated and maintained by specialist physicians experienced in the treatment of patients with KS.

Men

Patients should apply Panretin to cutaneous KS lesions using sufficient gel so as to cover each lesion with a generous coating.

Frequency of application

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:

GRADEDEFINING CLINICAL SIGNS
0 = No reactionNone
1 = MildDefinite pink to red coloration
2 = ModerateIncreased redness, possible oedema
3 = SevereVery red, with oedema, with or without vesiculation
4 = Very severeDeep 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 2No action required except continued monitoring.
Grade 3Treatment 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 4As 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.

Duration of application

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.

Precautions to be taken before handling or administering the medicinal product

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.

Women

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.

Paediatric population

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.

Elderly men

There are no specific recommendations for use in elderly men (above 65 years of age). AIDSrelated Kaposi’s sarcoma is infrequent in this population.

Patients with renal or hepatic impairment

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.

Overdose

No case of overdose has been reported.

Systemic toxicity following acute overdose with topical application of Panretin gel is unlikely.

Shelf life

Shelf life

Unopened: 3 years.

In-use: Any remaining tube should be discarded 90 days after first opening.

Special precautions for storage

Do not store above 25ยฐC.

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 25ยฐC, and should be protected from exposure to strong light and heat (e.g., direct sunlight).

Nature and contents of container

Panretin gel is supplied in a multi-use 60 g epoxy-lined aluminium tube.

Each carton contains one tube of gel.

Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

Panretin gel contains alcohol, keep away from naked flame.

ยฉ All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.