DOSING AND APPLICATION
- VALCHLOR is for topical dermatologic use only. Apply a thin film once daily to affected areas of the skin. Caregivers must wear disposable nitrile gloves when applying VALCHLOR. Patients and caregivers must wash hands thoroughly after handling or applying VALCHLOR.
IMPORTANT SAFETY INFORMATION
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: VALCHLOR is a cytotoxic drug. Avoid direct skin contact with VALCHLOR in individuals other than the patients due to risk of dermatitis, mucosal injury, and secondary cancers.
- Dermatitis: Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment or reduce dose frequency.
- Non-melanoma skin cancer: Monitor patients during and after treatment.
- Embryo-fetal toxicity: Women should avoid becoming pregnant or nursing while using VALCHLOR due to the potential hazard to the fetus.
- Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has dried.
The most common adverse reactions (≥ 5%) are dermatitis, pruritus, bacterial skin infection, skin ulceration or blistering, and hyperpigmentation. These reactions may be mild to severe. Elderly patients may be more susceptible. Depending on severity, dosing changes or discontinuation may be required.
Call your doctor for medical advice about side effects. To report suspected adverse reactions, contact Actelion Pharmaceuticals US, Inc., at 1-855-4-VALCHLOR (1-855-482-5245) or FDA at
1-800-FDA-1088, or visit www.fda.gov/medwatch.
This site is intended for US audiences only.
Please see full Prescribing Information and Medication Guide for VALCHLOR.