VALCHLOR- mechlorethamine gel
Actelion Pharmaceuticals US, Inc.
1 INDICATIONS AND USAGE
VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing and Dose Modification
For Topical Dermatological Use Only
Apply a thin film of VALCHLOR gel once daily to affected areas of the skin.
Stop treatment with VALCHLOR for any grade of skin ulceration, blistering, or moderately-severe or severe dermatitis (i.e., marked skin redness with edema) [see Warnings and Precautions (5.3) ]. Upon improvement, treatment with VALCHLOR 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.
2.2 Application Instructions
VALCHLOR is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Patients must wash hands thoroughly with soap and water after handling or applying VALCHLOR.
Caregivers must wear disposable nitrile gloves when applying VALCHLOR to patients and wash hands thoroughly with soap and water after removal of gloves. If there is accidental skin exposure to VALCHLOR, caregivers must immediately wash exposed areas thoroughly with soap and water for at least 15 minutes and remove contaminated clothing [see Warnings and Precautions (5.2) ].
Patients or caregivers should follow these instructions when applying VALCHLOR:
Apply immediately or within 30 minutes after removal from the refrigerator. Return VALCHLOR to the refrigerator immediately after each use.
Apply to completely dry skin at least 4 hours before or 30 minutes after showering or washing. Allow treated areas to dry for 5 to 10 minutes after application before covering with clothing.
Emollients (moisturizers) may be applied to the treated areas 2 hours before or 2 hours after application.
Do not use occlusive dressings on areas of the skin where VALCHLOR was applied.
Avoid fire, flame, and smoking until VALCHLOR has dried [see Warnings and Precautions (5.6) ].
3 DOSAGE FORMS AND STRENGTHS
The active ingredient in VALCHLOR is mechlorethamine. Each tube of VALCHLOR contains 60g of 0.016% w/w mechlorethamine clear gel (equivalent to 0.02% mechlorethamine HCl).
