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

Overview of Stage IA and IB MF-CTCL

Staging MF-CTCL

Stage IA2

  • Limited patches, papules, and/or plaques covering <10% of the skin's surface (T1)
  • No abnormal lymph nodes; biopsy not required (N0)
  • No visceral organ involvement (M0)
  • Absence of significant blood involvement: ≤5% of peripheral blood lymphocytes are atypical (Sezary) cells (B0)
    • Or, low blood tumor burden: >5% of peripheral blood lymphocytes are atypical (Sezary) cells (B1) but do not meet the criteria of B2

Stage IB2

  • Patches, papules, and/or plaques covering ≥10% of the skin's surface (T2)
  • No abnormal lymph nodes; biopsy not required (N0)
  • No visceral organ involvement (M0)
  • Absence of significant blood involvement: ≤5% of peripheral blood lymphocytes are atypical (Sezary) cells (B0)
    • Or, low blood tumor burden: >5% of peripheral blood lymphocytes are atypical (Sezary) cells (B1) but do not meet the criteria of B2

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.