For US Healthcare Professionals Only

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

A treatment for
Stage IA/IB MF-CTCL that is clear

Artistic rendition of Stage IA/IB MF-CTCL. Not an actual patient.

*VALCHLOR (n=119) was assessed in a 12-month randomized, multicenter, observer-blinded, noninferiority study trial (N=260) vs Aquaphor^®-based mechlorethamine HCl 0.02%. Primary endpoint: response by CAILS (Composite Assessment of Index Lesion Severity) score (combined scores for erythema, scaling, plaque elevation, and surface area). CAILS ORR: 60% (PR 45% + CR 14%). VALCHLOR noninferiority demonstrated by the rate ratio of 1.24 (95% CI, 0.98, 1.58). ORR (overall response rate) = PR (partial response) + CR (complete response, defined as a score of 0).¹

VALCHLOR is the first and only FDA-approved
topical form of mechlorethamine^1,2

Learn about the
VALCHLOR
clinical trial

Explore the resources of
VALCHLOR
Support^®

VALCHLOR copay program
Eligible patients^† pay
no more than ~~$10~~ $0 per
prescription fill

^†The VALCHLOR copay program is only available for US and Puerto Rico residents who are 18 or older and have commercial health insurance with copay/coinsurance exceeding ~~$10~~ $0 per prescription fill. Patients ineligible for the VALCHLOR copay program include those enrolled in Medicare, Medicaid, VA/DoD (Tricare), the Indian Health Service, or any other federal- or state-funded healthcare program, or where prohibited by law. The VALCHLOR copay program is not prescription drug coverage or insurance. Helsinn Therapeutics, Inc. reserves the right to terminate or modify this program at any time or without notice. Other terms and conditions apply.

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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.
Lymphoma Research Foundation. Understanding Lymphoma: Cutaneous T-Cell Lymphoma. Updated 2022. Accessed May 25, 2023. https://lymphoma.org/wp-content/uploads/2022/07/LRF_Cutaneous_T_Cell_Lymphoma_Fact_Sheet.pdf

A treatment for Stage IA/IB MF-CTCL that is clear