Chlormethine Ledaga^® (Gel) Instructions for Use

Marketing Authorization Holder

Recordati Rare Diseases (France)

Manufactured By

University of Iowa Pharmaceuticals (USA)

ATC Code

L01AA05 (Chlormethine)

Active Substance

Chlormethine (Rec.INN registered by WHO)

Dosage Form

Chlormethine Ledaga®

Gel for external use 160 mcg/1 g: 60 g tube

Dosage Form, Packaging, and Composition

Gel for external use

60 g – tubes – cardboard packs – By prescription

Pharmacotherapeutic Group

Antineoplastic agents; alkylating agents; nitrogen mustard analogues

Pharmacological Action

Chlormethine is a bifunctional alkylating agent that inhibits rapidly proliferating cells.

Pharmacokinetics

After application to the skin, measurable concentrations of chlormethine were absent in blood samples.

Indications

Treatment of mycosis fungoides – a form of cutaneous T-cell lymphoma.

ICD codes

Dosage Regimen

Apply once daily to the affected areas of the skin as a thin film.

Application should be discontinued upon the appearance of skin ulcerations or bullous rashes of any severity, or moderate and severe dermatitis (for example, pronounced skin redness with swelling). Application can be resumed after the skin condition has normalized, but with a lower frequency, i.e., once every 3 days.

If chlormethine is well tolerated for at least 1 week, the frequency of its application can be increased, i.e., applied every other day for at least 1 week, and then, if tolerance is maintained, switch to daily application.

Adverse Reactions

Immune system disorders common – hypersensitivity.

Skin and subcutaneous tissue disorders very common – dermatitis, skin infections, pruritus; common – skin ulcerations and bullous rashes, skin hyperpigmentation.

Contraindications

Hypersensitivity to chlormethine.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Safety and efficacy in children aged 0 to 18 years have not been established.

Geriatric Use

Approved for use in elderly patients.

Special Precautions

Contact of chlormethine with mucous membranes, especially the mucous membrane of the eyes, should be avoided.

Getting the substance on mucous membranes, for example, the oral or nasal cavity, causes pain, redness, and ulceration, including severe.

Getting chlormethine in the eyes causes pain, burns, inflammation, photophobia, and blurred vision. Blindness and severe irreversible damage to the anterior chamber of the eye may occur.

If the drug gets on the mucous membranes, patients should be advised to: immediately rinse the affected surface with plenty of water (or 0.9% sodium chloride solution for injection, or a special ophthalmic saline solution, in case the drug gets into the eyes) for at least 15 minutes, and immediately seek medical help (including consultation with an ophthalmologist if the substance gets into the eyes).

During treatment, patients should be examined for the presence of skin reactions, such as dermatitis (including redness, swelling, inflammation), pruritus, bullous rashes, ulcerations, and skin infections.

The face, external genitalia, perianal area, as well as areas of intertrigo are at the greatest risk of skin reactions with topical use of chlormethine.

Patients should be monitored for the development of skin cancer during and after treatment with chlormethine.

Persons who are not patients should avoid direct contact of this agent with the skin. Risks of secondary exposure may include skin reactions, mucous membrane damage, and skin cancer.

Storage Conditions

Store at below -18 °C. Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.