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

Stage IA/IB MF-CTCL is routinely managed by
qualified skin experts¹

Mycosis fungoides–type cutaneous T-cell lymphoma (MF-CTCL) is a difficult to diagnose, slowly progressing form of cancer that appears on skin^1-3

Example of Stage IA/IB MF-CTCL as Patches

Stage IA/Patch

Example of Stage IA/IB MF-CTCL as Plaques

Stage IB/Plaque

Example of Stage IA/IB MF-CTCL as Hypopigmentation

Stage IA/IB/Hypopigmentation

Actual Stage IA/IB MF-CTCL patient examples.

Early stage MF-CTCL patients may present with symptoms that often resemble, but are not, other inflammatory skin conditions such as psoriasis, eczema-like rashes, and non-specific dermatitis^1,2

These other skin conditions are not treated by VALCHLOR.

Non-MF-CTCL lesions

If your patients with Stage IA/IB MF-CTCL have received prior treatment such as topical corticosteroids, topical imiquimod, or phototherapy, it may be time for VALCHLOR.

Key risk factors for MF-CTCL

Common patient characteristics (not limited to)²:

Age: 55 to 60 years

Gender: Male

Race: African-American

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) recommendations for diagnosis⁴

Biopsy of suspicious skin sites
Review of a sufficient number of slides and/or at least one paraffin block representative of the lesion by a pathologist with expertise in the diagnosis of CTCLs
Immunohistochemistry panel of skin biopsy
Molecular analysis to detect clonal T-cell antigen receptor (TCR) gene rearrangement or other assessment of clonality

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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:

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
Ahn CS et al. Am J Dermatopathol. 2014;36(12):933-951.
Wilcox RA. Am J Hematol. 2016;91(1):151-165.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Primary Cutaneous Lymphomas V.1.2024. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed December 22, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Stage IA/IB MF-CTCL is routinely managed byqualified skin experts1

Mycosis fungoides–type cutaneous T-cell lymphoma (MF-CTCL) is a difficult to diagnose, slowly progressing form of cancer that appears on skin1-3

Early stage MF-CTCL patients may present with symptoms that often resemble, but are not, other inflammatory skin conditions such as psoriasis, eczema-like rashes, and non-specific dermatitis1,2

Key risk factors for MF-CTCL

Common patient characteristics (not limited to)2:

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommendations for diagnosis4

Request a Rep

Contact method*

I am seeking information about (select all that apply):

Important Safety Information

Contraindications

Warnings And Precautions

Adverse Reactions

Use In Specific Populations

Dosing and Application

Stage IA/IB MF-CTCL is routinely managed by
qualified skin experts¹

Mycosis fungoides–type cutaneous T-cell lymphoma (MF-CTCL) is a difficult to diagnose, slowly progressing form of cancer that appears on skin^1-3

Early stage MF-CTCL patients may present with symptoms that often resemble, but are not, other inflammatory skin conditions such as psoriasis, eczema-like rashes, and non-specific dermatitis^1,2

Common patient characteristics (not limited to)²:

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) recommendations for diagnosis⁴