Important Safety Information
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: 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
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.
Adverse reactions from the VALCHLOR clinical study
The most common adverse reactions (≥5%) were local skin reactions1
- In the pivotal trial, moderately severe to severe skin-related adverse reactions were managed with treatment reduction, suspension, or discontinuation. Concomitant use of topical steroids was not permitted during the study1
- 22% of patients treated with VALCHLOR and 18% of patients treated with compounded mechlorethamine discontinued treatment due to adverse reactions1
In the pivotal study, no systemic exposure was detected after topical administration of VALCHLOR1
- Blood samples were analyzed from 16 patients following treatment with VALCHLOR (mechlorethamine gel 0.016%) and 15 patients treated with an identical formulation consisting of mechlorethamine 0.032% w/w
- For patients who received mechlorethamine gel 0.016%, samples were collected to measure mechlorethamine concentrations prior to dosing, on day 1, and at the first month's visit
- Following the topical administration of mechlorethamine gel 0.016%, there were no detectable plasma mechlorethamine concentrations observed in any of the patients
- Patients who received mechlorethamine 0.032% had no measurable concentrations of mechlorethamine or half-mustard after 2, 4, or 6 months of treatment