160 micrograms / g gel
chloromethane
What Ledaga is and what it is used for
Ledaga contains the active substance chloromethane. It is an anti-cancer drug used on the skin to treat cutaneous T-cell lymphoma of the mycosis fungoides type (CTCL of the MF type).
MTC-type CTCL is a disease in which certain cells in the body’s immune system, the so-called T lymphocytes, become cancer cells and attack the skin. Chloromethine is a type of anti-cancer drug called an “alkylating agent”. It binds to DNA in dividing cells, such as cancer cells, which prevents them from multiplying and growing.
Ledaga is only for use on adults.
What you need to know before using Ledaga
Do not use Ledaga
- if you are allergic (hypersensitive) to chloromethine or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Ledaga.
- Eye contact must be avoided. Do not apply the medicine near the eyes, on the inside of the nostrils, on the inside of the ear or on the lips.
- If Ledaga enters the eyes, it may cause pain, burning, swelling, redness , photosensitivity and blurred vision. It can also lead to blindness and severe permanent damage to the eyes. If Ledaga gets into your eyes, immediately rinse your eyes for at least 15 minutes with large amounts of water, a solution called “0.9% sodium chloride solution” or an eye wash solution, and seek medical attention (including an ophthalmologist) as soon as possible.
- If this medicine gets into your mouth or nose, it can cause pain, redness and sores that can be serious. Rinse the affected area immediately for at least 15 minutes with large amounts of water and seek medical attention as soon as possible.
- This drug can cause skin reactions, such as inflammation of the skin ( redness and swelling), itching , blisters, sores and skin infections (see section 4) the risk of inflammation of the skin increases if you use Ledaga in the face, genitals, anus, or skin folds.
- Tell your doctor if you have ever had an allergic reaction to chloromethine. Contact your doctor or seek immediate medical attention if you develop allergic reactions to Ledaga (see section 4).
- Skin cancer (abnormal growth of the cells in the skin) has been reported after application of chloromethine to the skin, but it is not known if chloromethine causes this. Your doctor will check your skin for skin cancer during and after treatment with Ledaga. Tell your doctor if you get any new damaged areas or sores on the skin.
- Direct skin contact with Ledaga should be avoided in persons other than the patient, such as caregivers. Risks of direct skin contact include inflammation of the skin ( dermatitis ), damage to the eyes, mouth or nose, and skin cancer. Caregivers who accidentally come into contact with Ledaga must wash the affected area immediately for at least 15 minutes. Remove and wash all contaminated clothing. Seek medical attention immediately if Ledaga has entered your eyes, mouth or nose.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age, as safety and efficacy 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, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
There is limited experience with chloromethane in pregnant women. Therefore, the use of this drug is not recommended during pregnancy or for women of childbearing potential not using contraception.
It is not known if Ledaga is excreted in human milk, and there may be a risk of the breastfed baby being exposed to Ledaga through contact with the mother’s skin. Therefore, breastfeeding is not recommended when you are taking this medicine. You should talk to your doctor before breastfeeding to determine if it is best to breastfeed or to use Ledaga.
Driving and using machines
This medicine is not expected to affect your ability to drive or use machines.
Ledaga contains propylene glycol and butylhydroxytoluene
Propylene glycol and butylhydroxytoluene can also cause skin irritation. In addition, butylhydroxytoluene can also irritate the eyes and mucous membranes (ie mouth and nose).
How to use Ledaga
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Ledaga is only intended for use on the skin.
The recommended dose is applied as a thin film once a day on the affected areas. Dose one is the same for older patients (65 years and older) as for younger adult patients (18 years and older).
Your doctor may stop treatment if you develop severe inflammation of the skin (ie redness and swelling), blisters, and sores. Your doctor may start treatment again when your symptoms have improved.
Instructions for use:
- Always take Ledaga exactly as your doctor or pharmacist has told 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 any questions).
- Remove the cap from the tube just before use. Use the lid to pierce the seal.
- Apply Ledaga immediately or within 30 minutes after removing it from the refrigerator.
- Apply a thin layer of this medicine on completely dry skin at least 4 hours before, or 30 minutes after showering or washing.
- Apply Ledaga on affected skin areas. If unaffected skin areas come into contact with Ledaga, these should be washed with soap and water.
- Allow the area to dry for 5 to 10 minutes after applying the medicine, and before dressing.
- For patients applying gel: wash hands with soap and water immediately after application.
- For caregivers applying the gel: Carefully remove gloves (turn them inside out during removal to avoid contact with Ledaga) and wash hands thoroughly with soap and water.
- Ledaga is delivered in a child-protective, transparent, sealable plastic bag. Otherwise, ask your pharmacist.
- With clean hands, put Ledaga back in the packaging in which it was delivered and the packaging in the plastic bag. Put it back in the fridge after each use.
- Do not cover the treated area with air or waterproof dressings after applying this medicine.
- Avoid contact with an open flame or a lit cigarette until Ledaga has dried on the skin. Ledaga contains alcohol and is therefore considered flammable.
- Do not apply emollient creams and ointments or other skin products (including medicines applied to the skin) for 2 hours before or 2 hours after the daily application of Ledaga.
- Keep Ledaga away from children and avoid it coming into contact with food by storing Ledaga in its packaging and in the plastic bag.
If you use more Ledaga than you should
Do not apply Ledaga more than once a 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 the next dose when it’s time.
If you stop using Ledaga
Your doctor will decide how long you should use Ledaga and when the treatment can be stopped. Do not stop taking your medicine until your doctor tells you to.
If you have any further questions on the use of this product, 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 contact a doctor immediately if you get allergic reactions (hypersensitivity).
These reactions may include some or all of the following symptoms:
- Swelling of the lips, face, neck or tongue
- Rash
- Breathing difficulties
Other side effects may include:
Tell your doctor or pharmacist as soon as possible if you notice any of the following side effects below.
Very common side effects in the treatment area (may affect more than 1 in 10 people):
- Skin inflammation
- Infection is in the skin
- Itching
Common side effects in the treatment area (may affect up to 1 in 10 people):
- Skin ulcers
- Blisters
- Darker skin
How Ledaga should be stored
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 carton on “EXP”. The expiration date is the last day of the specified month.
Always store in the refrigerator (+ 2 ° C to + 8 ° C) and make sure that the tube is in the packaging of the child-resistant, transparent, sealable plastic bag.
Do not use any opened or unopened tube with Ledaga after 60 days in a refrigerator.
Ask the pharmacy staff how to dispose of medicines, nitrile gloves, and plastic bags that are no longer in use. Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is chloromethine. Each gram of gel contains 160 micrograms of chloromethine.
- The other ingredients are: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol , lactic acid , hydroxypropylcellulose, sodium chloride, racemic menthol, disodium edetate, butylhydroxytoluene.See end of section 2 for more information on propylene glycol and butylhydroxytoluene.
What the medicine looks like and contents of the pack
Ledaga is a clear, colorless gel.
Each aluminum tube contains 60 grams of gel and has a white screw cap.
Marketing Authorization Holder and Manufacturer:
Helsinn Birex Pharmaceuticals Ltd.
Damastown
Mulhuddart
Dublin 15
Ireland
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienRecordatiTel: +32 2 46101 36 | LithuaniaRecordati AB.Tel: + 46 8 545 80 230Sweden |
| BulgariaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France | Luxembourg / LuxemburgRecordatiTel: +32 2 46101 36Belgium / Belgium |
| Czech RepublicRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France | HungaryRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58Franciaország |
| DenmarkRecordati AB.Tel: + 46 8 545 80 230Sweden | MaltaRecord Rare DiseasesTel: +33 1 47 73 64 58Franza |
| GermanyRecordati Rare Diseases Germany GmbHTel: +49 731 140 554 0 | The NetherlandsRecordatiTel: +32 2 46101 36Belgium |
| EestiRecordati AB.Tel: + 46 8 545 80 230Rootsi | NorwayRecordati AB.Tel: + 46 8 545 80 230Sweden |
| GreeceRecordati Hellas:Ηλ: +30 210 6773822 | AustriaRecordati Rare Diseases Germany GmbHTel: +49 731 140 554 0Germany |
| SpainRecordati Rare Diseases Spain SLUTel: + 34 91 659 28 90 | PolandRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France |
| FranceRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58 | PortugalJaba Recordati SATel: +351 21 432 95 00 |
| CroatiaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58French | RomaniaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France |
| IrelandRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France | SloveniaRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France |
| IcelandRecordati AB.Phone: + 46 8 545 80 230Sweden | Slovak RepublicRecord Rare DiseasesTel: +33 (0) 1 47 73 64 58France |
| ItalyRecordati Rare Diseases Italy SrlTel: +39 02 487 87 173 | Finland / FinlandRecordati AB.Puh / Tel: +46 8 545 80 230Sweden |
| .ΠροςRecord Rare Diseases:Ηλ: +33 1 47 73 64 58.Αλλία | SwedenRecordati AB.Tel: +46 8 545 80 230 |
| LatviaRecordati AB.Tel: + 46 8 545 80 230Sweden | United Kingdom (Northern Ireland)Record Rare DiseasesTel: +33 (0) 1 47 73 64 58France |