Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ledaga 160 micrograms/g gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Chlormethine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Ledaga contains the active substance chlormethine. This is an anti-cancer medicine used on the skin to treat mycosis fungoidestype cutaneous T-cell lymphoma (MF-type CTCL). MF-type CTCL is a condition in which certain cells of the body's immune system called T-lymphocytes become cancerous and affect the skin. Chlormethine is a type of anti-cancer medicine called an 'alkylating agent'. It attaches to the DNA of dividing cells, like cancer cells, which stops them from multiplying and growing. Ledaga is for use in adults only.
What you need to know before you take it
e Ledaga Do not use Ledaga
- if you are allergic (hypersensitive) to chlormethine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Ledaga. –
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Contact with your eyes must be avoided. Do not apply the medicine near the eyes, to the inside of the nostrils, the inside of the ear or on the lips. If Ledaga gets in your eyes, it can cause pain, burning, swelling, redness, sensitivity to light, and blurred vision. It may also cause blindness and severe permanent injury to your eyes. If Ledaga gets in your eyes, rinse your eyes right away for at least 15 minutes with large amounts of water, a solution known as "0.9% sodium chloride solution" or an eye-wash solution, and seek medical assistance (including an eye doctor) as soon as possible. If this medicine gets in your mouth or nose, it can cause pain, redness, and ulcers that may be severe. Rinse the affected area right away for at least 15 minutes with large amounts of water, and seek medical assistance as soon as possible. This medicine can cause skin reactions, such as inflammation of your skin (redness and swelling), itching, blisters, ulcers and skin infections (see section 4). The risk for inflammation of the skin is increased if you apply Ledaga to your face, genital area, anus or skin folds. Tell your doctor if you have ever had an allergic reaction to chlormethine. Contact your doctor or seek immediate medical attention if you experience allergic reactions to Ledaga (see section 4). Skin cancers (abnormal growth of the cells in the skin) have been reported after application of chlormethine to the skin, although it is not known whether chlormethine causes this. Your doctor will check your skin for skin cancers during and after your treatment with Ledaga. Tell your doctor if you get any new damaged areas or ulcers on your skin. Direct skin contact with Ledaga should be avoided in individuals other than the patient, such as caregivers. Risks of direct skin contact include inflammation of the skin (dermatitis), injury to their eyes, mouth, or nose, and skin cancers. Caregivers who accidentally come into contact with Ledaga must wash the affected area right away for at least 15 minutes. Remove and wash any contaminated clothing. Get medical help right away if Ledaga gets into your eyes, mouth, or nose.
Children and adolescents Do not give this medicine to children and adolescents under the age of 18 years because the safety and effectiveness have not been established for this age group. Other medicines and Ledaga Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. There is limited experience of chlormethine in pregnant women. Therefore, the use of this medicine is not recommended during pregnancy and in women of childbearing age not using contraception. It is not known whether Ledaga passes into breast milk, and there may be a risk that the breast-feeding baby is exposed to Ledaga via contact with the mother's skin. Therefore, it is not recommended to breast-feed while taking this medicine. You should talk to your doctor before breast-feeding to determine whether or not it is best to breast-feed or to use Ledaga. Driving and using machines This medicine is not expected to have any effect on your ability to drive or to use machines. Ledaga contains propylene glycol and butylhydroxytoluene Propylene glycol may cause skin irritation. Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatits), or irritation to the eyes and mucous membranes.
How to take it
Ledaga Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Ledaga is intended only for use on the skin. The recommended dose is application as a thin film once a day to the affected areas of the skin. The dose is the same for elderly patients (aged 65 years and older) as for younger adult patients (aged 18 years and older). Your doctor may stop your treatment if you develop severe inflammation of the skin (i.e., redness and swelling), blisters and ulcers. Your doctor may restart the treatment upon improvement of your symptoms. Instructions for use:
- Use Ledaga exactly as your doctor or pharmacist tells you.
- Caregivers must wear disposable nitrile gloves when applying this medicine to patients (this is a special type of glove; ask your doctor or pharmacist if you have questions).
- Remove the cap from the tube just before use. Use the cap to pierce the seal.
- Apply Ledaga immediately or within 30 minutes of removing it from the refrigerator.
- Apply a thin layer of this medicine to completely dry skin at least 4 hours before or 30 minutes after showering or washing.
- Apply Ledaga to affected areas of the skin. In case of Ledaga exposure to non-affected areas of the skin, wash the exposed area with soap and water.
- Allow the area to dry for 5 to 10 minutes after applying your medicine and before covering with clothing.
- For patients applying the gel, wash your hands with soap and water immediately after applying.
- For caregivers applying the gel, carefully remove gloves (turning them inside out during the removal to avoid contact with Ledaga) and then wash hands thoroughly with soap and water.
- Ledaga is supplied within a child-resistant transparent, sealable, plastic bag. If it is not, ask your pharmacist.
- With clean hands, place Ledaga back in the box it came in and the box in the plastic bag. Return it to the refrigerator after each use.
- Do not cover the treated area with air- or water-tight bandages after you have applied this medicine.
- Until Ledaga has dried on the skin, avoid contact with an open flame or a lit cigarette. Ledaga contains alcohol and is therefore considered flammable.
- Do not apply moisturisers or any other skin products (including medicines applied to the skin) for 2 hours before or 2 hours after the daily application of Ledaga.
- Keep away from children and contact with food by storing Ledaga in its box and inside the plastic bag. If you use more Ledaga than you should Do not apply Ledaga more than once per day. If you apply more than recommended, talk to your doctor.
If you forget to use Ledaga Do not use a double dose to make up for a forgotten dose. Apply your next dose when it is due. If you stop using Ledaga Your doctor will determine how long you should use Ledaga for and when treatment may be stopped. Do not stop using your medicine until your doctor advises you to do so. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. STOP taking Ledaga and tell your doctor immediately if you experience allergic reactions (hypersensitivity). These reactions may include some or all of the following symptoms:
- Swelling of the lips, face, throat or tongue
- Rash
- Difficulty breathing Other side effects may include Tell your doctor or pharmacist as soon as possible if you notice any of the following side effects listed below. Very common side effects on the treatment area (may affect more than 1 in 10 people):
- Skin inflammation (dermatitis)
- Infections of the skin
- Itching (pruritus) Common side effects on the treatment area (may affect up to 1 in 10 people):
- Skin ulcers
- Blisters
- Darkening of the skin Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
How to store it
Ledaga Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the tube label and box after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (+2 °C to +8 °C) at all times, ensuring the tube is in the box inside the child-resistant, transparent, sealable, plastic bag. Do not use an opened or unopened tube of Ledaga after 60 days of storage in the refrigerator. Ask your pharmacist how to throw away used nitrile gloves, the plastic bag and the medicine you no longer use. Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.
Contents of the pack and other information
What Ledaga contains
- The active substance is chlormethine. Each gram of gel contains 160 micrograms of chlormethine.
- The other ingredients are: diethylene glycol monoethyl ether, propylene glycol (E 1520), isopropyl alcohol, glycerol (E 422), lactic acid (E 270), hydroxypropylcellulose (E 463), sodium chloride, menthol racemic, disodium edetate, and butylhydroxytoluene (E321). See end of section 2 for further information on propylene glycol and butylhydroxytoluene. What Ledaga looks like and contents of the pack Ledaga is a clear, colourless gel. Each aluminium tube contains 60 grams of gel and has a white screw cap.
Marketing Authorisation Holder and Manufacturer Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart Dublin 15 Ireland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Recordati Rare Diseases UK Ltd. Tel: +44 (0)1491 414333 This leaflet was last revised in 01/2022
Frequently asked questions about Ledaga 160 micrograms/g gel
How do I take Ledaga 160 micrograms/g gel?
Ledaga 160 micrograms/g gel comes as gel containing 160mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Ledaga 160 micrograms/g gel?
The active substance in Ledaga 160 micrograms/g gel is chlormethine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ledaga 160 micrograms/g gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ledaga 160 micrograms/g gel without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: chlormethine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T- cell lymphoma (MF-type CTCL) in adult patients (see section 5.1).
4.2. Posology and method of administration
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.
4.3. Contraindications
Hypersensitivity to chlormethine or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Mucosal or eye exposure
Contact with mucous membranes, especially those of the eyes, must be avoided. Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, and these may be severe. Exposure of the eyes to chlormethine causes pain, burns, inflammation, photophobia, and blurred vision.
Blindness and severe irreversible anterior eye injury may occur.
Patients should be advised that if any mucous membrane exposure occurs:
• irrigation should be performed immediately for at least 15 minutes with copious amounts of water (or sodium chloride 9 mg/ml (0.9%) solution for injection, or a balanced salt ophthalmic irrigating solution may be used if there is eye exposure), and
• medical care should be obtained immediately (including ophthalmological consultation if there is eye exposure).
Local skin reactions
Patients should be assessed during treatment for skin reactions such as dermatitis (e.g., redness, swelling, inflammation), pruritus, blisters, ulceration, and skin infections. The face, genitalia, anus, and intertriginous skin are at increased risk of skin reactions to topical chlormethine.
For dose modification information in case of skin reactions, see section 4.2.
Hypersensitivity
Hypersensitivity reactions, including isolated cases of anaphylaxis, have been reported in the literature after the use of topical formulations of chlormethine (see sections 4.3 and 4.8).
Skin cancer
Skin-directed therapies for MF-type CTCL have been associated with secondary skin cancers, although the specific contribution of chlormethine has not been established. Patients should be monitored for development of skin cancers during and after discontinuation of treatment with chlormethine.
Secondary exposure to Ledaga
Direct skin contact with Ledaga should be avoided in individuals other than the patient. Risks of secondary exposure may include skin reactions, mucosal injury, and skin cancers. Recommended application instructions should be followed to prevent secondary exposure (see section 4.2).
Excipients
This medicinal product contains propylene glycol and butylhydroxytoluene.
Propylene glycol may cause skin irritation.
Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Women of childbearing potential
Ledaga is not recommended in women of childbearing potential not using contraception.
Pregnancy
There are limited data from the use of chlormethine in pregnant women.
Studies in animals have shown reproductive toxicity after systemic administration (see section 5.3).
Ledaga is not recommended during pregnancy.
Breast-feeding
It is unknown whether chlormethine is excreted in human milk.
A risk to newborns/infants cannot be excluded due to the potential for topical or systemic exposure of the breast-feeding child to chlormethine through contact with the mother's skin.
A decision must be made whether to discontinue breast-feeding or to discontinue Ledaga therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the breast-feeding mother.
Fertility
In animals, adverse effects of chlormethine on male fertility after systemic administration have been documented (see section 5.3). The relevance to humans receiving topical chlormethine is unknown.
4.7. Effects on ability to drive and use machines
Ledaga has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
In a randomised-controlled trial (n=128 exposed to Ledaga for a median duration of 52 weeks), the most frequent adverse reactions to Ledaga were skin related: dermatitis (54.7%; e.g., skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%). Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients.
Tabulated list of adverse reactions
Adverse reactions reported with Ledaga in an active-controlled trial in patients with MF-type CTCL are shown below. Frequencies were defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Immune system disorders
Common
Hypersensitivity
Skin and subcutaneous tissue disorders
Very common
Dermatitis, skin infections, pruritus
Common
Skin ulceration and blistering, skin hyperpigmentation
Elderly population
In the controlled clinical trial, 31% (79/255) of the study population were aged 65 years or older. The safety profile observed in elderly patients was consistent with that in the overall patient population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- LEDAGA 160 micrograme/g prescriptionCHLORMETHINUM · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- LedagaChlormethinum
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Ledaga 160 micrograms/g gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.