产地国家：美国 处 方 药：是 所属类别：60克/管 包装规格：60克/管 计价单位：管 生产厂家中文参考译名：Actelion 生产厂家英文名：Actelion 原产地英文商品名：VALCHLOR gel 0.016% 60g/Tubes 原产地英文药品名：mechlorethamine 中文参考商品译名：Valchlor凝胶 60克/管 中文参考药品译名：氮芥

简介

美国FDA批准氮芥外用制剂VALCHLOR，每天一次凝胶局部施用，治疗患者以阶段IA和IB蕈样肉芽肿型皮肤T细胞淋巴瘤谁收到事先皮肤导向治疗(MF-CTCL)烷基化药物。Valchlor在美国被指定为孤儿药。 处方修改批准日期：2015年8月 公司：Actelion公司美国制药公司 VALCHLOR(氮芥 mechlorethamine)凝胶，局部使用 最初美国批准：1949年 作用机理 氮芥，也称为氮芥，是抑制快速增殖细胞的烷化剂。 适应症和用法 VALCHLOR是在患者中谁收到事先皮肤导向治疗阶段IA和IB蕈样肉芽肿型皮肤T细胞淋巴瘤的局部治疗所表示的烷基化的药物。 用法用量 对于只有局部皮肤使用 每日一次应用的薄膜对皮肤的受灾地区 剂型和规格 凝胶：0.016%w/w的氮芥(相当于0.02%氮芥HCl中)在60克管 禁忌症 严重过敏对氮芥 警告和注意事项 黏膜或眼外伤：VALCHLOR暴露于粘膜，特别是眼睛，可造成粘膜损伤可能是严重的。眼睛受伤可能会导致失明。立即冲洗至少15分钟，然后立即就医咨询。 二次曝光VALCHLOR：比其他病人的个人必须避免与VALCHLOR皮肤接触 皮炎：监测患者发红，肿胀，发炎，瘙痒，水疱，溃疡，和继发皮肤感染。停止治疗或减少剂量频率。 非黑色素瘤皮肤癌：治疗期间和治疗后监测患者。 胚胎 - 胎儿毒性：可引起胎儿造成伤害。告知潜在危险的妇女胎儿易燃凝胶：VALCHLOR是酒精类凝胶。避免引起火灾，火焰，吸烟，直到凝胶已干 不良反应 最常见的不良反应(≥5%)的皮炎，瘙痒，细菌性皮肤感染，皮肤溃疡或起泡，和色素沉着。 特殊人群中使用 哺乳母亲：请停止药物或哺乳

英文版说明书

氮芥外用软膏VALCHLOR(MECHLORETHAMINE HYDROCHLORIDE)GEL Valchlor (mechlorethamine) gel 0.016% is applied topically once a day to affected areas of the skin. Valchlor is the first and only FDA-approved topical formulation of mechlorethamine. CURRENT INDICATION In the US, Valchlor gel 0.016% is 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. Regulatory review with the European health authorities is ongoing. AVAILABLE CLINICAL DATA The efficacy of Valchlor was assessed in a randomized, multicenter, observer-blind, non-inferiority trial of 260 patients. Patients were stratified based on Stage (IA vs IB and IIA) and then randomized to receive Valchlor gel 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) or Aquaphor®-based mechlorethamine HCl 0.02% ointment (compounded mechlorethamine). Patients had received at least one prior skin-directed therapy. Qualifying prior therapies included topical corticosteroids, phototherapy, Targretin® gel, and topical nitrogen mustard. Patients were not required to be refractory to or intolerant of prior therapies. Treatments were applied topically on a daily basis for 12 months. 60% of the patients on the Valchlor arm and 48% of patients on the comparator arm achieved a response based on the Composite Assessment of Index Lesion Severity (CAILS) score. Valchlor was non-inferior to the comparator based on a CAILS overall response rate ratio of 1.24 (95% CI 0.98, 1.58). Complete responses constituted a minority of the CAILS or Severity Weighted Assessment Tool (SWAT) overall responses. The onset of CAILS overall response for both treatment arms showed a wide range from 1 to 11 months. The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and skin 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.