以下內(nèi)容僅供參考,實際診斷及用藥請遵從醫(yī)生指導(dǎo),使用前請仔細閱讀恩利/依那西普注射劑說明書;祝廣大病患者早日康復(fù)!
【藥品名稱】
商品名:  恩利
通用名:  依那西普注射劑
英文名:   Enbrel (Etanercept for Injection)
來源: 英利昔是利用重組DNA和單克隆抗體技術(shù)制備的人源化的人鼠嵌合搞TNFα受體單抗.
依那西普是wq由人Ig生產(chǎn)的抗TNFα受體單抗.
【成分】
主要成份：依那西普
輔料：甘露醇、蔗糖和氨丁三醇（Tris）。
【性狀】
白色凍干粉。溶劑為澄清、無色液體。
【作用機制】
本品為二聚體融合蛋白,由人類75kD腫瘤壞死因子(tumor necrosis factor, TNF)受體的細胞外配體結(jié)合部分和人類IgG1Fc段連接而成.本品Fc段含有GH2區(qū)、CH3區(qū)鉸鏈區(qū),但是不含有CH1區(qū).
近年來研究發(fā)現(xiàn)骨髓異常增生綜合征(myelo-dysplastic syndrome, MDS)伴有程序化細胞死亡(凋亡)加速,并且這種細胞凋亡與過度表達TNFα有關(guān).本品特異性地與TNFα受體結(jié)合,阻斷TNFa與細胞表面TNFα受體的相互作用;此外,本品還可以調(diào)節(jié)TNFα誘導(dǎo)或者介導(dǎo)的生物學(xué)作用.
【藥代動力學(xué)】
1.吸收:單藥25mg皮下注射.吸收較慢,平均69±34小時,達到血藥峰濃度.每周兩次,每次25mg皮下注射用藥6個月后,平均血藥濃度2.4±1.0 μg/ml.
2.分布:無資料.
3.半衰期:單藥25mg皮下注射,qc率160±80ml/h.平均半衰期102±20小時.
4.qc:經(jīng)體內(nèi)蛋白質(zhì)降解途徑qc.
【適應(yīng)證】
類風(fēng)濕關(guān)節(jié)炎(RA)：中度至重度活動性類風(fēng)濕關(guān)節(jié)炎的成年患者對包括甲氨蝶呤（如果不禁忌使用）在內(nèi)的DMARD（改善病情的抗風(fēng)濕藥）無效時，可用依那西普與甲氨蝶呤聯(lián)用zl。
已證實依那西普單獨使用或與甲氨蝶呤聯(lián)用時，可降低X線檢測相的關(guān)節(jié)損害進展率，并改善關(guān)節(jié)功能。
強直性脊柱炎(AS)：重度活動性強直性脊柱炎的成年患者對常規(guī)zl無效時可使用依那西普zl。
【用法用量】恩利需在有診斷和zl類風(fēng)濕關(guān)節(jié)炎和強直性脊柱炎經(jīng)驗的?？漆t(yī)生的指導(dǎo)下使用。
尚未進行yw相容性研究，禁止將依那西普與其他yw混合使用。
成，人(18x64歲)：
類風(fēng)濕關(guān)節(jié)炎：
推薦劑量為25mg每周二次（間隔72x96小時）或50mg每周一次，已證實50mg每周一次的yf案是安全有效的（參見藥理毒理部分）。
強直性脊柱炎：
推薦劑量為25mg每周二次（間隔72x96小時）或50mg每周一次。
老年患者(＞65歲)：無需進行劑量調(diào)整。用法用量與18x64歲的成x人相同。
肝腎功能損害的患者：無需進行劑量調(diào)整。
注射部位：
恩利的注射部位為大腿、腹部和上臂，注射方式為皮下~注射。每次在不同部位注射，與前次注射部位至少相距3cm。禁止注射于皮膚柔嫩、瘀傷、發(fā)紅或發(fā)硬部位。注射部位的選擇和注射方法的詳細信息請參見“注射用依那西普（恩利）的使用說明”。
處置：
依那西普凍干粉在使用前必須置于20Cx80C冰箱內(nèi)貯存，不可冷凍。恩利溶解后應(yīng)立即使用。如果不立即使用，應(yīng)將西林瓶中溶解后的依那西普注射液貯存于2℃x8℃冰箱內(nèi)，溶劑的預(yù)填充注射器橡皮塞中含有橡膠（干燥tr橡膠）。在接觸或使用依那西普之前，患者或護理人員應(yīng)聯(lián)系醫(yī)生詢問如何處置已知或可能對橡膠產(chǎn)生的過敏反應(yīng)（變態(tài)反應(yīng)）。
【劑型】
無菌白色不含防腐劑的凍干粉,每支含有Enbrel25mg,D-甘露醇40mg,蔗糖10mg,氨丁三醇1.2mg.依那西普為無菌凍干粉,每支含Remicade100mg.
劑量: 試驗zlMDS劑量(Remicade):3mg/kg靜脈用藥6次(第0、2、6、14、22、30周).Embrel,25mg皮下注射,每周2次,3個月為一療程.
給藥途徑: 皮下注射或者靜脈點滴.
配伍: 本品不宜與其他藥品混合使用并且不應(yīng)使用注射用水以外的溶媒溶藥.
【禁忌證】
敗血癥患者、已知對Embrel和Remicade或者制劑中其他成分過敏的患者禁用.心衰患者、老年患者、孕婦、哺乳期婦女慎用.
【不良反應(yīng)】
1.注射部位局灶反應(yīng):紅斑、痛癢、疼痛、腫脹、出血、瘀傷。平均持續(xù)3~5天,一般不需停藥.
2.感染:最常見下呼吸道感染,其他感染有:鼻炎、咽炎、腎盂腎炎、zqgy、膿毒性關(guān)節(jié)炎、腹腔膿腫、蜂窩織炎、骨髓炎、傷口感染、肺炎、足部膿腫、腿部潰瘍、腹瀉、鼻竇炎、敗血癥。并有可能增加原有感染患者的死亡率.
3.心血管系統(tǒng):心力衰竭、心肌梗死、心肌缺血、高血壓、低血壓、深靜脈血栓、血栓性靜脈炎。
4.消化系統(tǒng)：膽囊炎、胰腺炎、胃腸道出血、ft、xhbl、嘔吐、食欲不振、口干、口腔潰瘍。
5.肌肉骨骼系統(tǒng):滑囊炎、多發(fā)性肌炎、gjt、狼瘡樣綜合征。
6.神經(jīng)系統(tǒng):tt、眩暈、腦缺血、抑郁、多發(fā)性硬化、血管神精性水腫、偏癱、腦卒中、dx、孤立性脫髓鞘病、橫斷性脊髓炎、視神精炎。
7.呼吸系統(tǒng)：咳嗽、呼吸困難、肺栓塞、間質(zhì)性肺炎。
8.泌尿生死系統(tǒng):膜性腎小球腎炎.
9.血液系統(tǒng):淋巴結(jié)腫大、貧血、再生障礙性貧血、白細胞減少癥、粒細胞減少癥、全血減少、血小板減少癥。
10.皮膚病變:脈管炎、皮下結(jié)節(jié)、風(fēng)疹、皮疹、脫發(fā)。
【臨床應(yīng)用規(guī)程】
1.用藥前做血常規(guī)、心電圖、超聲心動圖等檢查，評定左室功能。
2.用藥前準備好搶救過敏反應(yīng)yw和簡易呼吸器.
3.用英利昔前可預(yù)防性應(yīng)用抗組胺藥和解熱鎮(zhèn)痛yw.用依那西普前可僅用抗組胺類藥.
4.監(jiān)測血壓、呼吸、心率等生命體征。
5.用藥期間均需監(jiān)測血象,進行左室功能評定.出現(xiàn)下述情況應(yīng)考慮停藥:確定相關(guān)的明顯的血液學(xué)異常、嚴重過敏反應(yīng)、狼瘡樣綜合征。監(jiān)測病情直至癥狀和體征恢復(fù)正常。
6.使用時以1ml無菌注射用水溶解.稀釋劑應(yīng)緩慢注入藥瓶中,盡量避免搖動或劇烈震動.嚴禁將兩支藥品溶液混用,或者將一支中的藥液倒入另一支中.如果藥液出現(xiàn)褪色、絮狀物、顆粒狀物質(zhì)，應(yīng)廢棄不用。
【貯存】
原藥避光貯于2～8℃。溶解后最多只能保存14天
【包裝】
每盒包裝中包括2瓶注射用依那西普，2支注射用水預(yù)填充注射器，2支針頭，2支接合器和4支酒精棉簽;每盒包裝中包括4瓶注射用依那西普，4支注射用水預(yù)填充注射器，4支針頭，4支接合器和8支酒精棉簽
【規(guī)格】
25mg*0.5ml*2支/盒 2460元/盒
25mg*0.5ml*4支/盒 4900元/盒
【有效期】
36個月
【批準文號】
注冊證號S20120006
【原批準文號】
注冊證號S20100019
【生產(chǎn)廠家】
德國輝瑞制藥有限公司

【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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