Topical formulations of chlormethine.
Mycosis fungoides-type cutaneous T-cell lymphoma in adults.
A thin film applied once daily to affected skin.
Pregnancy and Lactation
Chlormethine is contraindicated during pregnancy.
The manufacturer states that chlormethine is not recommended during pregnancy.
Animal studies have shown reproductive toxicities. There is limited data in the use of pregnant women.
Chlormethine is contraindicated during breastfeeding.
The manufacturer states that a decision must be made whether to discontinue breastfeeding or discontinue treatment with chlormethine, taking into account the benefit of breastfeeding to the child and the benefit of treatment to the breastfeeding mother.
The risk to newborns/infants cannot be excluded due to the potential for exposure of the breastfeeding child to chlormethine through skin contact with the breastfeeding mother. It is unknown whether chlormethine is excreted in human milk.
Advise patient to wash hands thoroughly with soap and water immediately after handling or applying gel.
Caregivers should remove gloves carefully and wash hand thoroughly with soap and water.
In the case of accidental skin exposure, wash exposed areas with soap and water for at least 15 minutes.
Advise patient to remove and wash contaminated clothing.
Do not use and contact the pharmacist if the seal is missing, punctured or lifted.
Apply within 30 minutes after removal from the refrigerator, and return to the refrigerator immediately after each use.
Advise patient to dry skin thoroughly before application.
Advise patient to apply at least 4 hours before or 30 minutes after showering or washing.
Advise patient to allow treated areas to dry for 5 to 10 minutes after application before covering with clothing.
Emollients or other topical products may be applied to the treated skin 2 hours before or after application.
Advise patient to avoid fire, flame and smoking until chlormethine gel has dried.
Avoid contact with mucous membranes, including those of the eyes, mouth and nose. If exposure to any mucous membrane occurs wash with water, saline or ophthalmic irrigating solution and seek medical care immediately.
Avoid contact with skin not being treated.
Advise patient to report adverse skin reactions.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: August 2019
Summary of Product Characteristics: Chlormethine 160micrograms/g gel. Recordati Rare Diseases UK Ltd. Revised April 2019.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.