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chlormethine

Ledaga · ATC code L01AA05

Also known as: Chlormethin, Klormetin

Key facts
Active substance
chlormethine
Drug class
Nitrogen mustard
ATC code
L01AA05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Ledaga 160 micrograms/g gel
Marketing authorisation holder
Helsinn Birex Pharmaceuticals Ltd.
Information as of
2026-10-28

Key facts

Chlormethine is an alkylating agent applied as a gel for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma in adults (Ledaga).

What it is used for

  • Topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.

Dosing

  • Ledaga gel: apply a thin film once daily to affected areas of the skin.
  • Stop for any grade of skin ulceration or blistering, or for moderately severe or severe dermatitis; on improvement restart once every 3 days, then every other day if tolerated for at least 1 week, then once daily.
  • Elderly: same dosing as younger adults; not established in children and adolescents.
  • Apply to completely dry skin at least 4 hours before or 30 minutes after showering; use within 30 minutes of removal from the refrigerator; no occlusive dressings.
  • Wash hands thoroughly after applying; caregivers must wear disposable nitrile gloves. Avoid fire, flame and smoking until dry.

Contraindications

  • Hypersensitivity to chlormethine or any excipient.

Important warnings

  • Avoid contact with mucous membranes, especially the eyes: pain, burns, inflammation and blurred vision; blindness and severe irreversible eye injury may occur. If exposed, irrigate immediately for at least 15 minutes with copious water and seek medical care.
  • Local skin reactions (dermatitis, pruritus, blisters, ulceration, skin infections); face, genitalia, anus and intertriginous skin are at increased risk.
  • Hypersensitivity reactions, including isolated cases of anaphylaxis.
  • Secondary skin cancers may occur; monitor during and after treatment.
  • Direct skin contact with the gel by other people should be avoided.

Side effects

  • Most frequent, skin-related: dermatitis (54.7%), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%) and skin hyperpigmentation (5.5%).
  • Cutaneous hypersensitivity reactions in 2.3% of patients.

Interactions

  • No interaction studies have been performed.

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception.
  • Breast-feeding: a risk to the child via skin contact cannot be excluded; decide between stopping breast-feeding or therapy.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • LedagaHelsinn Birex Pharmaceuticals Ltd. · EMEA/H/C/002826

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Ledaga
Liechtenstein
Ledaga
Norway
Ledaga

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Ledaga – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/ledaga-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC L01AA.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.