VALCHLOR® (mechlorethamine) gel is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF‑CTCL) in patients who have received prior skin-directed therapy

Dosing and administration of VALCHLOR

VALCHLOR is a non-greasy, quick-drying, once-daily gel for topical administration1

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 (ie, marked skin redness with edema)
    • Upon improvement, application of VALCHLOR can be restarted at a reduced frequency: once every 3 days for at least 1 week if tolerated, then every other day for at least 1 week, and then to once daily if tolerated

Application instructions1

  • Patients must wash hands thoroughly with soap and water after handling or applying VALCHLOR
  • Caregivers must wear disposable nitrile gloves when applying VALCHLOR, and must 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
  • 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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine.

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and hyperpigmentation (5%). These reactions may be moderately severe or severe. Elderly patients aged 65 and older may be more susceptible. Depending on severity, treatment reduction, suspension, or discontinuation may be required.

DOSING AND APPLICATION

VALCHLOR is for topical dermatologic use only. Apply a thin film of gel once daily to affected areas of the skin. VALCHLOR is a cytotoxic drug and special handling and disposal procedures should be followed during use. Caregivers must wear disposable nitrile gloves when applying VALCHLOR. Patients and caregivers must wash hands thoroughly after handling or applying VALCHLOR.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn Therapeutics (U.S.), Inc., at 1-855-4-VALCHLOR (1-855-482-5245) or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see VALCHLOR full Prescribing Information.