12月6日，美国食品药品管理局（FDA）批准Xiaflex一种新适应症，用于治疗男性阴茎弯曲，一种称作纤维性海绵体炎的疾病（佩罗尼氏病），这也是用于该疾病的首款药物。Xiaflex是第一个获FDA批准用于该疾病男性患者的非手术治疗选择，这类患者的阴茎内存有一种斑块（肿块），可导阴茎致勃起时出现至少30度的弯曲变形。
佩罗尼氏病由阴茎皮下出现瘢痕组织引起。这种瘢痕组织在勃起期间引起不规则弯曲，并能引起令人讨厌的性交症状等问题。"今天的批准为佩罗尼氏病男性患者增加了治疗选择，"FDA药物评价与研究中心骨、生殖和泌尿产品部门副主任、医学博士Audrey Gassman 说。
Xiaflex于2010年首次被批准用于杜普伊特伦挛缩治疗，这是一种进行性手部疾病，可影响人拉直和正确使用手指的能力。Xiaflex通过将积聚的胶原（可引起阴茎弯曲变形）进行分解而起到作用。佩罗尼氏病的一个疗程最多包括4个治疗周期。
每个治疗周期由两个 Xiaflex注射程序（在该程序中Xiaflex被直接注射入含有胶原的阴茎组织中）和一个由卫生保健专业人员实施的阴茎建模程序构成。
Xiaflex治疗佩罗尼氏病的安全性和有效性基于两项随机、双盲、安慰剂对照研究，受试者为 820 名阴茎弯曲变形至少达 30度的佩罗尼氏病男性患者。受试者接受Xiaflex或安慰剂总共4个周期的治疗，然后随访52周。Xiaflex治疗与安慰剂相比能明显降低阴茎弯曲变形的程度及相关令人讨厌的影响。
在治疗佩罗尼氏病时，Xiaflex只能按照一个风险评估和降低策略 (REMS) 及一项限制计划来获取，因这款药物存有严重副作用，包括阴茎折断（阴茎轴内阴茎体的断裂）及其他严重阴茎损伤。
Xiaflex用来治疗佩罗尼氏病时，应该由一位在治疗男性泌尿疾病方面富有经验的卫生保健专业人员来管理。REMS要求参与卫生保健的专业人员通过注册及完成 Xiaflex 治疗佩罗尼氏病用药管理培训来进行程序内认证。REMS 也要求卫生保健设施通过程序内认证，以确保Xiaflex只能由通过认证的卫生保健专业人员分发。
与使用Xiaflex治疗佩罗尼氏病相关的最常见不良反应包括阴茎血肿、阴茎肿胀和阴茎疼痛。鼓励消费者和卫生保健专业人员向FDA网站上的医疗观察不良事件报告程序报告因使用 Xiaflex而出现的不良反应。Xiaflex由位于Chesterbrook, Pa的Auxilium制药公司上市销售。
What is XIAFLEX
XIAFLEX is approved for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of XIAFLEX in the treatment of Peyronie's disease.
What is the XIAFLEX REMS
A REMS (Risk eva luation and Mitigation Strategy) is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. Endo Pharmaceuticals has worked with the FDA to develop the XIAFLEX REMS Program.
The XIAFLEX REMS requires a review of educational materials, training, and certification.
XIAFLEX is available for the treatment of Peyronie's disease only through the XIAFLEX REMS Program. The XIAFLEX REMS Program requirements include:
Training for healthcare providers on the risks of corporal rupture and other serious injuries to the penis, and how to properly administer XIAFLEX.
Certification in the XIAFLEX REMS Program by completing training and enrollment in the program.
Patient Counseling about the risks of corporal rupture and other serious injuries to the penis and the importance of patient adherence to post-injection instructions. Healthcare Providers must give patients the Patient Counseling Tool, "What You Need to Know About XIAFLEX Treatment for Peyronie's Disease: A Patient Guide", after each XIAFLEX injection.
Restricted Distribution through specially certified healthcare settings (e.g., pharmacies, practitioners, hospitals or outpatient settings).
Healthcare Provider Certification
To become certified in the XIAFLEX REMS Program, healthcare providers must read the prescribing information, take the training (video or guide) and complete the Enrollment Form.
Pharmacy/Healthcare Setting Certification
To become certified in the XIAFLEX REMS Program, pharmacies and healthcare settings must complete the Pharmacy/Healthcare Setting Enrollment Form. |
