Ledaga

/ Rafa

For Topical Dermatological Use Only. Apply a thin film of Chlormethine gel once daily to affected areas of the skin. Stop treatment with Chlormethine for any grade of skin ulceration, blistering, or moderately-severe or severe dermatitis (i.e., marked skin redness with edema). Upon improvement, treatment with Chlormethine can be restarted at a reduced frequency of once every 3 days.  If reintroduction of treatment is tolerated for at least one week, the frequency of application can be increased to every other day for at least one week and then to once daily application if tolerated (See prescribing information for full details). Pediatric Use – Safety and effectiveness in pediatric patients have not been established.

Topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.

Patients with known severe hypersensitivity to chlormethine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of chlormethine.

Mucosal or Eye Injury: Exposure of the eyes to chlormethine causes pain, burns, inflammation, photophobia, and blurred vision.  Blindness and severe irreversible anterior eye injury may occur.  Advise patients that if eye exposure occurs, (1) immediately irrigate for at least 15 minutes with copious amounts of water, normal saline, or a balanced salt ophthalmic irrigating solution and (2) obtain immediate medical care (including ophthalmologic consultation). Exposure of mucous membranes such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe.  Should mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation.
Secondary Exposure to Chlormethine: Avoid direct skin contact with Chlormethine in individuals other than the patient. Risks of secondary exposure include dermatitis, mucosal injury, and secondary cancers. Follow recommended application instructions to prevent secondary exposure.
See prescribing information for full details.

For full details see prescribing information.

No drug interaction studies have been performed with Chlormethine.   Systemic exposure has not been observed with topical administration of Chlormethine; therefore, systemic drug interactions are not likely.

Pregnancy: Category D.
Lactation: Nursing Mothers – It is not known if chlormethine is excreted in human milk.  Due to the potential for topical or systemic exposure to Chlormethine through exposure to the mother’s skin, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

See prescribing information for full details.

Storage: At the pharmacy and at home: store in a refrigerator (2°C to 8°C), use within 60 days. This drug is cytotoxic. Follow applicable special handling and disposal procedures.