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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

VALCHLOR application and storage

VALCHLOR is for topical use only. It is a cytotoxic drug with special handling and disposal procedures.

VALCHLOR gel self-application offers flexibility for patient use¹

Apply once daily to dry skin icon

Apply once daily to dry skin

Wash hands with soap and water after touching/applying

Caregivers must wear disposable nitrile gloves when applying and wash hands thoroughly with soap and water after removal of gloves. If there is accidental exposure to VALCHLOR, caregivers must immediately wash exposed areas thoroughly with soap and water and remove contaminated clothing

Stop treatment for any grade of skin ulceration, blistering, or moderately severe or severe dermatitis

A small amount as a thin layer icon

Apply a small amount as a thin layer

Apply to completely dry skin 4 hours before or 30 minutes after showering or bathing

Must apply immediately or 30 minutes after removal from the refrigerator. Return VALCHLOR to the refrigerator immediately after each use

Let dry for 5 to 10 minutes icon

Let dry for 5 to 10 minutes

Treated area should be allowed to dry before covering with clothing

Occlusive (air or water-tight) dressings should not be used on areas of the skin where VALCHLOR was applied

Can be disposed of in household trash icon

Can be disposed of in household trash

Unused VALCHLOR gel, empty tubes, and used application gloves should be discarded in household trash in a manner that prevents accidental application or ingestion by others, including children and pets

VALCHLOR should be stored in the refrigerator¹

Store at a temperature between 36ºF and 46ºF (2ºC and 8ºC)
Apply immediately or within 30 minutes after removal from the refrigerator. Return to refrigerator immediately after use
Keep VALCHLOR in its original box and away from food
Unused product should be thrown away after 90 days
Keep VALCHLOR gel out of the reach of children and pets

Remind patients that:

It may take several months of appropriate use to see desired results with VALCHLOR^1-3
Dermatitis may occur with VALCHLOR. Let patients know that these may be managed with dose modifications. Patients should tell their healthcare provider if they experience skin irritation¹
VALCHLOR should be kept away from eyes, mouth, and nose. If accidentally exposed, rinse for at least 15 minutes with large amount of water (normal saline or eye wash solution for eye exposure) and get medical help right away¹
Patients should notify their physician of any new skin lesions and undergo periodic assessment for signs and symptoms of skin cancer. Non-melanoma skin cancers have been reported in 2% of patients receiving VALCHLOR, some of whom had received prior therapies known to cause non-melanoma skin cancer. Non-melanoma skin cancer may occur at multiple areas, including areas not treated with VALCHLOR¹
Females should not breastfeed during treatment with VALCHLOR¹
Women should avoid pregnancy while using VALCHLOR. Males with female partners of reproductive potential should use a barrier method of contraception while using VALCHLOR¹

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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

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: May cause fetal harm. Women should avoid becoming pregnant while using VALCHLOR due to the potential hazard to the fetus. For nursing mothers, do not breastfeed during treatment with VALCHLOR
Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has dried

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.

Use In Specific Populations

Contraception: Females who are able to become pregnant, and males with female partners who are able to become pregnant, should use a barrier method of contraception to avoid direct exposure of reproductive organs to VALCHLOR
Infertility: The reproductive effects of VALCHLOR have not been studied: however systemically administered mechlorethamine may impair fertility. The reversibility of the effect on fertility is unknown.

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 thoroughly wash hands after handling or applying VALCHLOR.

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

Please see the VALCHLOR full Prescribing Information and Medication Guide (EN/ES).

References:

VALCHLOR [package insert]. Iselin, NJ: Helsinn Therapeutics US, Inc.; January 2020.
Geskin LJ et al. Clin Lymphoma Myeloma Leuk. 2021;21(2):119-124.
Lessin SR et al. JAMA Dermatol. 2013;149(1):25-32.