部份中文恩利处方资料（仅供参考）
商品名称：恩利（Enbrel）
通用名称：注射用依那西普
英文名称：Etanercept for Injection
成份：依那西普 Etanercept
性状：外观呈白色冻干粉.溶剂为澄清、无色液体.
适应症
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治疗.
用法用量
需在有诊断和治疗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.
贮藏
恩利使用前于2-8°C冰箱内贮存.避免冻结.
恩利溶解后应立即使用.已证明在2-8°C的条件下可保持48小时的化学和物理稳定.然而从微生物学角度考虑,恩利应立即使用.如果不能及时使用,应将西林瓶中溶解后的依那西普注射液贮存于2-8°C冰箱内,使用者应确保贮存时间,通常在2-8°C的条件下不超过6小时,除非溶解是在严格控制并经过验证的无菌条件下进行的.
剂  型：粉针剂
规  格：25mg/瓶
有效期：36个月
生产企业：辉瑞制药有限公司 
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 adverse events were comparable to control patients in rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis clinical trials.
The most common adverse 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.
Print this page
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 advanced 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 adverse 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.
---------------------------------------------------------------
附件:

200842108092833.pdf