VALCHLOR (mechlorethamine hydrochloride) gel
[Actelion Pharmaceuticals US, Inc.]
FDA批准Ceptaris公司Valchlor(氮芥)用于治疗IA和IB阶段蕈样肉芽肿的新药申请，蕈样肉芽肿是一种皮肤T细胞淋巴瘤（CTCL）。Ceptaris公司称，Valchlor是一种外用氮芥（烷化剂类抗肿瘤药），将于下一季度在美国上市。Ceptaris计划与Actelion公司共同向欧盟提交Valchlor的新药申请，但具体的时间安排还在研究中。Valchlor在美国被指定为孤儿药。
GHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use VALCHLOR™ safely and effectively. See full prescribing information for VALCHLOR.
VALCHLOR (mechlorethamine) gel, for topical use
Initial U.S. Approval: 1949
INDICATIONS AND USAGE
VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy (1).
DOSAGE AND ADMINISTRATION
For topical dermatological use only (2.1).
Apply a thin film once daily to affected areas of the skin (2.1, 2.2).
DOSAGE FORMS AND STRENGTHS
Gel: 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) in 60g tubes (3)
CONTRAINDICATIONS
Severe hypersensitivity to mechlorethamine (4)
WARNINGS AND PRECAUTIONS
Mucosal or eye injury: VALCHLOR exposure to mucous membranes, especially of the eyes, can cause mucosal injury which may be severe. Eye injury may lead to blindness. Immediately irrigate for at least 15 minutes followed by immediate medical consultation (5.1).
Secondary exposure to VALCHLOR: individuals other than the patient must avoid skin contact with VALCHLOR (2.2, 5.2).
Dermatitis: Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment or reduce dose frequency (2.1, 5.3).
Non-melanoma skin cancer: Monitor patients during and after treatment (5.4).
Embryo-fetal toxicity: Can cause fetal harm. Advise women of potential hazard to a fetus (5.5, 8.1).
Flammable gel: VALCHLOR is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has dried (2.2, 5.6).
ADVERSE REACTIONS
The most common adverse reactions (≥5%) are dermatitis, pruritus, bacterial skin infection, skin ulceration or blistering, and hyperpigmentation (6.1).
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 www.fda.gov/medwatch
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