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

Frequently asked questions about VALCHLOR

What are the dosage and dose modification of VALCHLOR?1

  • 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

How should VALCHLOR be applied?1

VALCHLOR is a cytotoxic drug. Follow applicable special handling and disposal procedures. 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.

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

Who should not use VALCHLOR?1

Patients should not use VALCHLOR if they are severely allergic to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine.

What are the warnings and precautions for VALCHLOR?1

  • Mucosal or eye injury: Exposure of mucous membranes to mechlorethamine such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe. Exposure of the eyes causes pain, burns, inflammation, photophobia, and blurred vision. Blindness and severe irreversible anterior eye injury may occur. Should eye exposure or mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation
  • Secondary exposure: Avoid direct skin contact with VALCHLOR in individuals other than the patients due to risk of dermatitis, mucosal injury, and secondary cancers
  • Dermatitis: Dermatitis may be moderately severe or severe. Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment with VALCHLOR or reduce dose frequency
  • Non-melanoma skin cancer: Monitor patients during and after treatment with VALCHLOR
  • Embryo-fetal toxicity: Women should avoid becoming pregnant while using VALCHLOR due to the potential hazard to the fetus. For nursing mothers, discontinue use of VALCHLOR or nursing
  • Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has dried

What are the most common adverse reactions to VALCHLOR?1

The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and skin 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.

Does systemic exposure occur with VALCHLOR?1

Systemic exposure has not been observed with topical administration of VALCHLOR. Learn more here

How is VALCHLOR stored?1

  • VALCHLOR must be stored in the refrigerator between 36°F and 46°F (2°C to 8°C)
  • VALCHLOR must be kept away from food in the refrigerator
  • With clean hands, patients must place VALCHLOR back in the box it came in and return it to the refrigerator right after use
  • Patients should talk to their pharmacist before using VALCHLOR that has been out of the refrigerator for more than 1 hour a day
  • VALCHLOR that is not used after 90 days must be safely thrown away. Unused VALCHLOR, empty tubes, and used disposable nitrile gloves should be safely thrown away in household trash
  • VALCHLOR and all medicines must be kept out of the reach of children

How do I prescribe VALCHLOR?

To prescribe VALCHLOR, first download, complete, and fax the VALCHLOR Patient Intake and Prescription Form available here

A specialty pharmacy ships VALCHLOR directly to the patient’s home under refrigerated conditions and provides monthly refill reminders.

Are support programs available for VALCHLOR patients?

VALCHLOR Support provides comprehensive resources to help patients start and stay on therapy. The program includes assistance with insurance verification, financial assistance for eligible patients, disease and product information, and prescription management and refill reminders. You can find out more about VALCHLOR Support here

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.