通用名称为SIMPONI

戈利木单抗50mg/0.5mL soln注射;不含防腐剂。

法律分类：

RX

药理类为SIMPONI

肿瘤坏死因子受体阻滞剂。

对SIMPONI制造商

扬森生物科技有限公司
      
主治为SIMPONI

中度至严重活动性类风湿关节炎（RA）的组合，与甲氨蝶呤（MTX）。积极银屑病关节炎（PsA），单独或与甲氨蝶呤。积极强直性脊柱炎（AS）。
      
成人剂量为SIMPONI

50毫克。

儿童剂量为SIMPONI

<18yrs：不推荐。
      
为SIMPONI警告/注意事项

严重或致命感染的危险性增加（例如，肺结核，细菌性败血症，侵袭性真菌）。积极感染：不要开始治疗。慢性或历史经常性或机会性感染。条件易患感染。旅行，或居住在结核病流行的地区或霉菌病。测试和治疗潜伏性结核开始治疗之前。

密切监测，如果新的感染，B型肝炎病毒（HBV）的活化，如果严重或投机或血液dyscrasias发展;停止感染，败血症，HBV再激活，新的或恶化，瑞士法郎，或血液学异常（如血细胞减少）的发展。瑞士法郎（显示器）。

免疫抑制。

中枢神经系统脱髓鞘疾病。恶性肿瘤。胶乳过敏。老人。怀孕（Cat.B）。

哺乳母亲：

不推荐。

为SIMPONI的相互作用

并发阿贝西普，anakinra的，活疫苗，或其他肿瘤坏死因子受体阻滞剂：没有建议。免疫抑制剂增加感染的风险。监视器的CYP450
基板与治疗指数狭窄。

为SIMPONI不良反应

注射部位反应，感染（可能是严重的），上呼吸道感染，鼻咽炎，高血压;罕见：恶性肿瘤（例如，淋巴瘤，尤指儿童），血液恶液质，新的或恶化瑞士法郎，提高肝酶，抗体的形成，加重或新的牛皮癣发病。

SIMPONI如何提供？

单剂量SmartJect自动进1;单剂量预充式注射器1

      
相关疾病：
强直性脊柱炎
关节炎
类风湿关节炎

Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Monograph title
GOLIMUMAB - SUBCUTANEOUS INJECTION

Phonetic pronunciation
(goe-LIM-ue-mab)

Common brand name(s)
Simponi

Warning
This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infections to watch out for, and seek immediate medical attention if you develop any of these symptoms.If you are diagnosed with TB, to prevent the infection from becoming serious you must first be treated for it before you start golimumab.Though it is very unlikely to happen, there is a risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin) due to this medication or due to your medical condition. Discuss the risks and benefits of treatment with your doctor. Tell your doctor immediately if you develop symptoms such as unusual lumps/growths, swollen glands, swollen or painful abdomen, unexplained weight loss, persistent fever or night sweats.

Uses
This medication is used to reduce pain and swelling due to certain types of arthritis (such as rheumatoid, psoriatic, and ankylosing spondylitis). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage. By reducing joint swelling, the medication helps to reduce further joint damage and preserve joint function. Depending on the type of arthritis that is being treated, this drug may be used alone or in combination with another drug called methotrexate.

How to use
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using golimumab and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.Use this medication exactly as prescribed. This drug is given by injection under the skin of the thigh, abdomen, or upper arm, usually once a month, or as directed by your doctor. Learn all preparation and usage instructions in the product package. Never shake this product. Doing so may decrease the effectiveness of the drug.Remove this medication from the refrigerator and leave it at room temperature for 30 minutes before injecting. Do not warm up this medication any other way such as by heating in the microwave or placing in hot water.Before using, check this product visually for particles or discoloration. The liquid is usually colorless to pale yellow and may contain tiny particles that are white or that you can see through. If the liquid is any darker than pale yellow, if it is discolored in any other way, or if it contains large particles, do not use the liquid.Before injecting each dose, clean the injection site with rubbing alcohol.It is important to change the injection site with each dose. Do not inject into any areas of skin that are sore, bruised, red, scaly, or hard.Use this medication regularly to get the most benefit from it. To help you remember, mark the day on the calendar when you need to receive the medication.Learn how to store and discard needles and medical supplies safely. Never reuse syringes or needles. Consult your pharmacist.Tell your doctor if your condition persists or worsens.

Missed dose
If you miss a dose, contact your doctor or pharmacist to establish a new dosing schedule.

Precautions
See also Warnings section.Before using golimumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: an active infection, TB infection, fungal infections (such as histoplasmosis, coccidioidomycosis), heart disease (congestive heart failure), lupus, recurrent infections, hepatitis B infection, decreased bone marrow function, seizures, certain brain/spinal cord disorders (such as multiple sclerosis), history of cancer (such as lymphoma), scheduled surgery.Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine. Consult your doctor about the risks of exposure to chickenpox and other infections.Older adults may be more sensitive to the effects of this drug, especially the risk of infections.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, consult your doctor before breast-feeding.

Side effects
Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/irregular/pounding heartbeat, stomach pain, blood in the stools, mental/mood changes, severe headache, easy bruising/bleeding, dark urine, yellowing eyes/skin, leg pain/swelling, numbness/tingling of the hands/feet, unsteadiness, unexplained muscle weakness, vision changes, extreme fatigue, joint pain, butterfly-shaped rash on the nose and cheeks.Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, chest pain.Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, persistent sore throat, persistent cough, night sweats, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Some of the products that may interact with this drug include: abatacept, live vaccines, other TNF-blockers (such as adalimumab, certolizumab, etanercept, infliximab), other arthritis drugs (such as anakinra, methotrexate, prednisone, leflunomide), drugs that suppress the immune system (such as cyclosporine).This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Overdose
If overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes
Do not share this medication with others.Laboratory and/or medical tests (such as complete blood counts, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

Medical alert
Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (US), or 1-800-668-1507 (Canada).

Storage
Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. Discard any unused portion of this medication. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

戈利木单抗注射液(golimumab，Simponi)—活动期类风湿性关节炎、活动期银屑病关节炎和强直性脊柱炎生物药在加美批准上市

近日；美国FDA批准了先灵葆雅公司的戈利木单抗50mg注射剂上市，一月1次皮下注射治疗中度至严重活动期类风湿性关节炎、活动期银屑病关节炎和强直性脊柱炎。

早在2009年4月13日，加拿大在全球率先批准戈利木单抗注射剂(golimumab，Simponi)上市，用于治疗中度至严重活动期类风湿性关节炎、活动期银屑病关节炎和强直性脊柱炎。

加拿大还批准戈利木单抗与甲氨蝶呤联用来减少中度至严重活动期类风湿性关节炎成人患者的症候和症状、单独或与甲氨蝶呤联用减少中度至严重活动期银屑病关节炎成人患者的症候和症状、单独或与甲氨蝶呤联用减少不能采用常规药物治疗的强直性脊柱炎成人患者的症候和症状。戈利木单抗是迄今批准首个可同时治疗3种不同类型的皮肤疾病。

戈利木单抗系一新的人抗肿瘤坏死因子(TNF)单克隆抗体，采用Medarex公司靶向及中和过量TNF-α的UltiMAb技术制成。由于慢性炎症疾病在体内产生过量的蛋白质TNF-α，可造成骨、软骨和组织炎症和损伤。戈利木单抗一月1次皮下注射抗TNF-α的治疗，可采用戈利木单抗SmartJect自动注射器或预填充注射器给药。戈利木单抗还正在研究采用静脉滴注的给药途径来治疗类风湿性关节炎。

在一项最大的Ⅲ期临床研究中，评价了治疗银屑病关节炎的疗效，显示戈利木单抗50mg显著改善活动期银屑病关节炎症候和症状。与此相似，Ⅲ期临床评价了治疗强直性脊柱炎的疗效显示，戈利木单抗50mg显著改善活动期强直性脊柱炎症候和症状。继续使用戈利木单抗，可快速和持续改善银屑病和强直性脊柱炎患者症状。

在最全面抗TNF-α治疗的临床开发计划中评价了戈利木单抗的有效性和安全性，包括同时研究类风湿性关节炎、银屑病关节炎和强直性脊柱炎。此计划包括2000例5项关键的Ⅲ期临床研究，结果作为美国FDA批准的主要依据。本品在治疗类风湿性关节炎中患者面广，包括初次使用甲氨蝶呤的成人、采用甲氨蝶呤治疗无效的成人和先前至少使用过一种TNF-α治疗药的成人，在3项研究中的一项，戈利木单抗50mg加甲氨蝶呤治疗组较安慰剂加甲氨蝶呤和(或)其它抗风湿性药组改善关节炎症状至少显著高出20%，继续注射戈利木单抗治疗可改善50%和70%的症状。

规格:50mg/0.5ml  10支 x 0.5ml  预充式

Company: MSD.

Active ingredient: Golimumab 50mg/0.5ml.
Description: Solution for injection in pre-filled pen.
Indications: Treatment of moderate to severe, active rheumatoid arthritis in combination with methotrexate (MTX) when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate. Treatment of active and progressive psoriatic arthritis, alone or in combination with MTX, when the response to previous DMARD therapy has been inadequate. Treatment of severe, active ankylosing spondylitis in patients who have responded inadequately to conventional therapy.

Pharmacology:Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-α, which prevents the binding of TNF-α to its receptors.
Dosage: Adult: 50mg by subcutaneous injection once a month, on the same date each month. Response is usually achieved within 12 to 14 weeks (after 3-4 doses). Patients weighing >100kg, if inadequate response after 3-4 doses, may be increased to 100mg once a month; reconsider treatment if no benefit achieved after 3-4 additional doses of 100mg. Elderly: As per adults. Children: Under 18 years, not recommended.

Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis (TB), severe infections (such as sepsis), opportunistic infections. Moderate or severe heart failure (NYHA class III/IV). Pregnancy (unless clearly necessary), lactation (for at least 6 months after treatment).
Special precautions: Monitor closely for infections including TB before, during and for up to 5 months after therapy; discontinue if a serious infection occurs. May occur: Reactivation of hepatitis B. Caution: Hepatitis B carriers, history of malignancy, elderly, hepatic impairment. Renal/ hepatic impairment: No data. Malignancies reported in children and adolescents treated with TNF-blockers. Increased risk for lymphoma and leukaemia. Severe persistent asthma, COPD, heavy smoking (increased risk of malignancies). Mild heart failure (NYHA class I/II); discontinue if new or worsening symptoms. Assess benefit/risk in patients with pre-existing or recent onset of demyelinating disorders, including multiple sclerosis. Surgery (monitor closely for infections). Discontinue if patient develops symptoms of lupus-like syndrome and is positive for antibodies against double-stranded DNA. Pancytopenia, leukopenia, neutropenia, aplastic anemia, thrombocytopenia, cytopenias including pancytopenia, have been reported; consider discontinuation. Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last treatment. Driving/using machines. Contains sorbitol, fructose. Packaging contains latex.

Drug interactions: Not recommended: Anakinra, abatacept, live vaccines.

Adverse drug reactions: Upper respiratory tract infections (nasopharyngitis, pharyngitis, laryngitis, rhinitis), bacterial infections (cellulitis), viral infections (influenza, herpes), bronchitis, sinusitis, superficial fungal infections, anaemia, allergic reactions(bronchospasm,hypersensitivity, urticaria), autoantibody positive, depression, insomnia, dizziness, paresthesia, headache, hypertension, GI upset, increased ALT/AST, alopecia, dermatitis, pruritus, rash, pyrexia, asthenia, injection site reactions, impairedhealing,chestdiscomfort.