Alefacept,Amevive阿法赛特(人源L FA-3/IgG1融合蛋白)
美国食品及药物管理局FDA批准了又一种牛皮癣新药Amevive，属名为alefacept，用于治疗中度及严重噬斑型牛皮癣成人患者。
Amevive的作用机制是减少与牛皮癣有关的免疫性反应，后者会增加皮肤感染甚至发生恶性病变的危险。FDA是根据最近完成的两项双盲随机临床治疗结果做出上述批准的。这两项研究总共涉及到1,060例慢性噬斑型牛皮癣成人患者，结果表明Amevive组患者的病变皮肤面积、病变程度以及与此有关的炎症反应都要比对照组得到更为显著的改善。可能发生的副作用包括咽喉痛、眩晕、咳嗽、恶心以及肌肉酸痛等。鉴于目前还不大清楚该药对妊娠的影响，有关专家建议孕妇应当与AME-VIVE药厂(Biogen公司)取得联系，以便后者监测可能对胎儿发生的任何副作用。此外专家们还提醒说，患者在接受Amevive治疗期间还需要定期检查白细胞数。
Biogen公司的人源L FA-3/IgG1融合蛋白alefacept（AmeviveTM）能够与T-细胞结合，抑制T-细胞激活和产生，导致T-细胞选择性的凋亡，该药已经在美国和欧洲完成了治疗牛皮癣的III期临床试验。1000名中重度牛皮癣患者参加的试验数据表明，在每周静脉注射该药后，71％的患者牛皮癣面积和严重程度得分（PASI）改善了50％以上，40％的患者PASI改善了75％以上。现在该药在美国和欧洲申请治疗中重度慢性噬斑性牛皮癣。
药物名称
通用名：
阿法 品牌名称：赛特
生产厂家
Biogen Inc.
适应症
该药物是用于治疗中度至重度慢性斑块型银屑病
使用方法
严格按照规定使用这种药物。 这种药物是由医疗专业人士每周一次给予肌肉注射（IM）的。
如果您有任何疑问，请遵医嘱。
注意事项
在使用这种药物时，如果您有：癌症，感染史，目前正接受化疗, 请咨询您的医生或药剂师。
使用这种药物时，请告诉您的医生或药剂师您的病史，尤其是：经常性感染（如肺炎 ，皮肤感染），免疫系统疾病（免疫抑制），任何过敏; 没有免疫/未经医生同意接种疫苗，避免与口服小儿麻痹症疫苗的人接触。
这种药物可能引起晕眩，谨慎从事一些活动: 如驾驶或使用机器。
这种药物不应使用于儿童。
老年人: 谨慎对待，因为他们可能更敏感，容易产生副作用。
目前还不清楚这种药物是否进入母乳, 母乳喂哺者不建议使用这种药物。
药物相互作用
在使用此药，请告诉您的医生或药剂师, 您正使用的处方药和非处方药. 特别是：药物可能抑制免疫系统（如癌症化疗 ， 泼尼松 ，环孢素），活疫苗等。
不良反应
可能包括（但不限于）以下内容：
严重感染
恶性肿瘤
淋巴细胞
喉咙痛
头晕
咳嗽
恶心
发痒
肌肉酸痛
发冷
注射部位疼痛
注射部位炎症
意外伤害
储藏
室温15-30摄氏度避光保存。 远离儿童和宠物。
Brand names: Amevive®
Alefacept injection
What is Alefacept injection?
ALEFACEPT (Amevive®) is used for adult patients with moderate or severe chronic plaque psoriasis. Alefacept works by stopping the overactive white blood cells that cause psoriasis. Generic alefacept injections are not yet available.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
• acquired immunodeficiency syndrome (AIDS)
• currently receiving vaccinations
• fever or infection
• an immune deficiency (natural or due to cancer chemotherapy, radiation, or steroid therapy or HIV infection)
• an unusual reaction to alefacept, medicines, foods, dyes, preservatives or any human or hamster proteins
• pregnant or trying to get pregnant
• breast-feeding
How should this medicine be used?
Alefacept is for injection or infusion into the muscle or a vein. It is given by a health-care professional in a hospital or clinic setting. You will be given an infusion or injection once a week for 12 weeks.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What if I miss a dose?
It is important not to miss a dose. Let your prescriber or health care professional know if you are unable to keep an appointment.
What drug(s) may interact with Alefacept?
• medicines that suppress the immune system
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What should I watch for while taking Alefacept?
Visit your prescriber or health care professional for checks on your progress. You will need to have regular checks on your white blood cells. The side effects of alefacept can continue after you finish your treatment; report side effects promptly.
Alefacept will decrease your body's ability to fight infections. Call your prescriber or health care professional if you have a fever, chills, sore throat or other symptoms of a cold or flu. Do not treat these symptoms yourself. Try to avoid being around people who are sick. If prescribed for you, make sure to take antibiotics as directed.
Do not have any vaccinations without your prescriber's approval and avoid anyone who has recently had the oral polio vaccine.
What side effects may I notice from receiving Alefacept?
Side effects that you should report to your prescriber or health care professional as soon as possible:
• chest pain or tightness
• dark or brown urine
• difficulty breathing or swallowing
• fast or irregular heart beat
• loss of appetite
• low blood counts - alefacept may decrease the number of white blood cells. You may be at increased risk for infections.
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• skin rash or itchy skin
• severe abdominal pain
• stomach pain (severe)
• swelling of your face or tongue
• swelling of the hands, feet or ankles, or rapid weight gain
• vomiting
• yellowing of your skin or the whites of your eyes
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• chills
• cough
• dizziness
• headache
• nausea
• pain at the site of injection
Where can I keep my medicine?
Alefacept injection will be given to you in a hospital or clinic setting. You will not take this medicine at home.
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