以下内容仅供参考,实际诊断及用药请遵从医生指导,使用前请仔细阅读恩利/依那西普注射剂说明书;祝广大病患者早日康复!
【药品名称】
商品名: 恩利
通用名: 依那西普注射剂
英文名: Enbrel (Etanercept for Injection)
来源: 英利昔是利用重组DNA和单克隆抗体技术制备的人源化的人鼠嵌合搞TNFα受体单抗.
依那西普是wq由人Ig生产的抗TNFα受体单抗.
【成分】
主要成份：依那西普
辅料：甘露醇、蔗糖和氨丁三醇（Tris）。
【性状】
白色冻干粉。溶剂为澄清、无色液体。
【作用机制】
本品为二聚体融合蛋白,由人类75kD肿瘤坏死因子(tumor necrosis factor, TNF)受体的细胞外配体结合部分和人类IgG1Fc段连接而成.本品Fc段含有GH2区、CH3区铰链区,但是不含有CH1区.
近年来研究发现骨髓异常增生综合征(myelo-dysplastic syndrome, MDS)伴有程序化细胞死亡(凋亡)加速,并且这种细胞凋亡与过度表达TNFα有关.本品特异性地与TNFα受体结合,阻断TNFa与细胞表面TNFα受体的相互作用;此外,本品还可以调节TNFα诱导或者介导的生物学作用.
【药代动力学】
1.吸收:单药25mg皮下注射.吸收较慢,平均69±34小时,达到血药峰浓度.每周两次,每次25mg皮下注射用药6个月后,平均血药浓度2.4±1.0 μg/ml.
2.分布:无资料.
3.半衰期:单药25mg皮下注射,qc率160±80ml/h.平均半衰期102±20小时.
4.qc:经体内蛋白质降解途径qc.
【适应证】
类风湿关节炎(RA)：中度至重度活动性类风湿关节炎的成年患者对包括甲氨蝶呤（如果不禁忌使用）在内的DMARD（改善病情的抗风湿药）无效时，可用依那西普与甲氨蝶呤联用zl。
已证实依那西普单独使用或与甲氨蝶呤联用时，可降低X线检测相的关节损害进展率，并改善关节功能。
强直性脊柱炎(AS)：重度活动性强直性脊柱炎的成年患者对常规zl无效时可使用依那西普zl。
【用法用量】恩利需在有诊断和zl类风湿关节炎和强直性脊柱炎经验的专科医生的指导下使用。
尚未进行yw相容性研究，禁止将依那西普与其他yw混合使用。
成，人(18x64岁)：
类风湿关节炎：
推荐剂量为25mg每周二次（间隔72x96小时）或50mg每周一次，已证实50mg每周一次的yf案是安全有效的（参见药理毒理部分）。
强直性脊柱炎：
推荐剂量为25mg每周二次（间隔72x96小时）或50mg每周一次。
老年患者(＞65岁)：无需进行剂量调整。用法用量与18x64岁的成x人相同。
肝肾功能损害的患者：无需进行剂量调整。
注射部位：
恩利的注射部位为大腿、腹部和上臂，注射方式为皮下~注射。每次在不同部位注射，与前次注射部位至少相距3cm。禁止注射于皮肤柔嫩、瘀伤、发红或发硬部位。注射部位的选择和注射方法的详细信息请参见“注射用依那西普（恩利）的使用说明”。
处置：
依那西普冻干粉在使用前必须置于20Cx80C冰箱内贮存，不可冷冻。恩利溶解后应立即使用。如果不立即使用，应将西林瓶中溶解后的依那西普注射液贮存于2℃x8℃冰箱内，溶剂的预填充注射器橡皮塞中含有橡胶（干燥tr橡胶）。在接触或使用依那西普之前，患者或护理人员应联系医生询问如何处置已知或可能对橡胶产生的过敏反应（变态反应）。
【剂型】
无菌白色不含防腐剂的冻干粉,每支含有Enbrel25mg,D-甘露醇40mg,蔗糖10mg,氨丁三醇1.2mg.依那西普为无菌冻干粉,每支含Remicade100mg.
剂量: 试验zlMDS剂量(Remicade):3mg/kg静脉用药6次(第0、2、6、14、22、30周).Embrel,25mg皮下注射,每周2次,3个月为一疗程.
给药途径: 皮下注射或者静脉点滴.
配伍: 本品不宜与其他药品混合使用并且不应使用注射用水以外的溶媒溶药.
【禁忌证】
败血症患者、已知对Embrel和Remicade或者制剂中其他成分过敏的患者禁用.心衰患者、老年患者、孕妇、哺乳期妇女慎用.
【不良反应】
1.注射部位局灶反应:红斑、痛痒、疼痛、肿胀、出血、瘀伤。平均持续3~5天,一般不需停药.
2.感染:最常见下呼吸道感染,其他感染有:鼻炎、咽炎、肾盂肾炎、zqgy、脓毒性关节炎、腹腔脓肿、蜂窝织炎、骨髓炎、伤口感染、肺炎、足部脓肿、腿部溃疡、腹泻、鼻窦炎、败血症。并有可能增加原有感染患者的死亡率.
3.心血管系统:心力衰竭、心肌梗死、心肌缺血、高血压、低血压、深静脉血栓、血栓性静脉炎。
4.消化系统：胆囊炎、胰腺炎、胃肠道出血、ft、xhbl、呕吐、食欲不振、口干、口腔溃疡。
5.肌肉骨骼系统:滑囊炎、多发性肌炎、gjt、狼疮样综合征。
6.神经系统:tt、眩晕、脑缺血、抑郁、多发性硬化、血管神精性水肿、偏瘫、脑卒中、dx、孤立性脱髓鞘病、横断性脊髓炎、视神精炎。
7.呼吸系统：咳嗽、呼吸困难、肺栓塞、间质性肺炎。
8.泌尿生死系统:膜性肾小球肾炎.
9.血液系统:淋巴结肿大、贫血、再生障碍性贫血、白细胞减少症、粒细胞减少症、全血减少、血小板减少症。
10.皮肤病变:脉管炎、皮下结节、风疹、皮疹、脱发。
【临床应用规程】
1.用药前做血常规、心电图、超声心动图等检查，评定左室功能。
2.用药前准备好抢救过敏反应yw和简易呼吸器.
3.用英利昔前可预防性应用抗组胺药和解热镇痛yw.用依那西普前可仅用抗组胺类药.
4.监测血压、呼吸、心率等生命体征。
5.用药期间均需监测血象,进行左室功能评定.出现下述情况应考虑停药:确定相关的明显的血液学异常、严重过敏反应、狼疮样综合征。监测病情直至症状和体征恢复正常。
6.使用时以1ml无菌注射用水溶解.稀释剂应缓慢注入药瓶中,尽量避免摇动或剧烈震动.严禁将两支药品溶液混用,或者将一支中的药液倒入另一支中.如果药液出现褪色、絮状物、颗粒状物质，应废弃不用。
【贮存】
原药避光贮于2～8℃。溶解后最多只能保存14天
【包装】
每盒包装中包括2瓶注射用依那西普，2支注射用水预填充注射器，2支针头，2支接合器和4支酒精棉签;每盒包装中包括4瓶注射用依那西普，4支注射用水预填充注射器，4支针头，4支接合器和8支酒精棉签
【规格】
25mg*0.5ml*2支/盒 2460元/盒
25mg*0.5ml*4支/盒 4900元/盒
【有效期】
36个月
【批准文号】
注册证号S20120006
【原批准文号】
注册证号S20100019
【生产厂家】
德国辉瑞制药有限公司
【英文版】
About Enbrel? (etanercept)
How does ENBREL work?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body makes called TNF. Tumor necrosis factor is made by your body's immune system. People with immune diseases such as RA, JRA, AS, psoriatic arthritis, and plaque psoriasis have too much TNF in their bodies.
About moderate to severe rheumatoid arthritis
About moderate to severe juvenile rheumatoid arthritis
About ankylosing spondylitis
About psoriatic arthritis
About chronic moderate to severe plaque psoriasis
Important information about taking prescription ENBREL
ENBREL can reduce the amount of TNF in the body. And while ENBREL can block the damage that too much TNF can cause, it can also lower the ability of your immune system to fight infections. So, taking ENBREL can make you more prone to getting infections or make any infection that you may have worse. To find out more about prescription ENBREL, talk with your doctor. Your doctor is the best source of information. You can also view the Important Safety Information. If you have additional questions, call 1-888-4ENBREL (1-888-436-2735). This line is open Monday through Friday, 8:00 am to 11:00 pm, Eastern Time.
How ENBREL is taken
Administering ENBREL can be convenient. ENBREL is a protein and is injected (by you or someone else) just under the skin. Once you've filled your prescription, schedule a training session with your doctor's office to learn the proper techniques for self-injection. During this session, you may administer your first dose of ENBREL. You'll learn what you need to know at the doctor's office to inject ENBREL at home.
Proven experience
ENBREL has more than 14 years of collective clinical experience.
The first ENBREL clinical trials began in 1992. Since its approval for moderate to severe rheumatoid arthritis in 1998, ENBREL has also been approved for use in treating moderate to severe juvenile rheumatoid arthritis (JRA), psoriatic arthritis, ankylosing spondylitis (AS), and moderate to severe plaque psoriasis.
Established safety profile
The safety profile for ENBREL during clinical trials showed:
Rates of serious ad‘verse events were comparable to control patients in rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis clinical trials.
The most common ad‘verse events reported were injection site reactions, infections, and headache.
Routine laboratory monitoring specific for ENBREL therapy is not required; however, careful medical management and supervision of patients are recommended. Tell your doctor if you are prone to infection or have had hepatitis B.
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Learn More:
rheumatid arthritis
juvenile rheumatoid arthritis
psoriatic arthritis
ankylosing spondylitis
plaque psoriasis
What important safety information do I need to know about taking prescription ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.
Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections have been fatal. Many serious infections occurred in people prone to infection. Serious infections have also occurred in patients with ad‘vanced or poorly controlled diabetes. Do not start ENBREL if you have an infection or are allergic to ENBREL or its components. Once on ENBREL, if you get an infection or have any sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you closely for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes have been reported. There have been rare reports of serious blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients who were not taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.
Tell your doctor if you:
Think you have, are being treated for, have signs of, or are prone to infection
Have any open sores
Have or have had TB or hepatitis B
Have ever been treated for heart failure
Have ever had or develop a serious nervous system disorder
Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ENBREL
Common side effects in adult clinical trials were injection site reaction, infection and headache.
In a medical study of patients with JIA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults. The kinds of infections reported were generally mild and similar to those usually seen in children. Other serious ad‘verse reactions were reported, including serious infection and depression/personality disorder.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. If you have any questions about this information, be sure to discuss them with your doctor. Please see full Prescribing Information.
INDICATIONS
Moderate to Severe Rheumatoid Arthritis (RA)
ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
In medical studies, ENBREL was shown to be effective in about 2 out of 3 adults with RA who used it, and has been shown to begin working in as few as 2 weeks, with most patients receiving benefit within 3 months. In an RA medical study, 55% of patients had no progression of joint damage.
Moderate to Severe Polyarticular Juvenile Idiopathic Arthritis (JIA)
ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
In medical studies, ENBREL was shown to be effective in about 3 out of 4 children with JIA who used it. For these JIA patients, ENBREL has been shown to begin working in approximately 2 to 4 weeks.
Psoriatic Arthritis
ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.
In medical studies, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients who used it. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Ankylosing Spondylitis (AS)
ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
In a medical study, ENBREL was shown to be effective in about 3 out of 5 adults with AS who used it. Clinical responses were seen at 2 weeks in 46% of patients, with 59% of patients receiving benefit within 8 weeks.
Moderate to Severe Plaque Psoriasis
ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
In medical studies, nearly half of patients saw a significant improvement in their plaque psoriasis within 3 months of using ENBREL. Overall, 3 out of 4 patients saw improvement. ENBREL can work fast; many patients saw improvement within 2 months. ENBREL has been shown to be effective through 12 months of therapy.
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