LEDAGA Gel Ref.[9059] Active ingredients: Chlormethine

Treatment with Ledaga should be initiated by an appropriately experienced physician.

Posology

A thin film of Ledaga should be applied once daily to affected areas of the skin.

Treatment with Ledaga should be stopped for any grade of skin ulceration or blistering, or moderately severe or severe dermatitis (e.g., marked skin redness with oedema). Upon improvement, treatment with Ledaga can be restarted at a reduced frequency of once every 3 days. If reintroduction of treatment is tolerated for at least 1 week, the frequency of application can be increased to every other day for at least 1 week and then to once-daily application if tolerated.

Elderly

The dosing recommendation for elderly patients (≥65 years old) is the same as for younger adult patients (see section 4.8).

Paediatric population

The safety and efficacy of Ledaga in children aged 0 to 18 years have not been established. No data are available.

Method of administration

Ledaga is for topical application to the skin.

The following instructions should be followed by patients or caregivers when applying Ledaga:

• Patients must wash hands thoroughly with soap and water immediately after handling or applying Ledaga. Patients should apply Ledaga to affected areas of the skin. In case of Ledaga exposure to non-affected areas of the skin, patients should wash the exposed area with soap and water.
• Caregivers must wear disposable nitrile gloves when applying Ledaga to patients. Caregivers should remove gloves carefully (turning them inside out during the removal to avoid contact with Ledaga) and wash hands thoroughly with soap and water after removal of gloves. If there is accidental skin exposure to Ledaga, caregivers must immediately wash exposed areas thoroughly with soap and water for at least 15 minutes. Remove and wash contaminated clothing.
• The opening of the tube is covered with a foil safety seal. The cap should be used to puncture the seal. The tube should not be used and the pharmacist should be contacted if the seal is missing, punctured, or lifted.
• Ledaga should be applied immediately or within 30 minutes after removal from the refrigerator. The tube should be returned to the refrigerator immediately after each use. With clean hands, the tube should be placed back into the original box and the box should be placed in the supplied transparent, sealable, plastic bag for storage in the refrigerator.
• Ledaga should be applied to completely dry skin at least 4 hours before or 30 minutes after showering or washing. The patient should allow treated areas to dry for 5 to 10 minutes after application before covering with clothing. Occlusive (air- or water-tight) dressings should not be used on areas of the skin where Ledaga was applied.
• Emollients (moisturisers) or other topical products may be applied to the treated areas 2 hours before or 2 hours after application of Ledaga.
• Fire, flame, and smoking must be avoided until Ledaga has dried.

No cases of overdose after cutaneous use of Ledaga were reported during the clinical development programme or post-marketing period. Management of overdose should consist of washing the exposed area with water.

Frozen tube: 4 years in the freezer (–15°C to –25°C).

After defrosting: 60 days in the refrigerator (+2°C to +8°C).

Ledaga should be removed from the refrigerator just prior to application and returned to the refrigerator immediately after each use in its box inside the child-resistant, transparent, sealable, plastic bag.

Unopened tube: Store and transport frozen (−15°C to −25°C) or refrigerated (+2°C to +8°C).

After defrosting: Store and transport refrigerated (+2°C to +8°C).

Ledaga is provided in a white aluminium tube with an inner lacquer and an aluminium seal and a white polypropylene screw cap. Each tube contains 60 g of gel.

Ledaga is a cytotoxic medicinal product.

Caregivers must wear nitrile gloves when handling Ledaga. Patients and caregivers must wash hands after handling Ledaga.

Ledaga is an alcohol-based product and is flammable. The recommended application instructions should be followed (see section 4.2).

Unused refrigerated Ledaga should be discarded after 60 days, together with the plastic bag.

Any unused medicinal product or waste material, including the plastic bag and the nitrile gloves used for application, must be disposed of in accordance with local requirements.