通用名称SIMPONI
Golimumab 50mg/0.5mL;溶液为SC损伤;不含防腐剂。

法律分类：
接收

药理班SIMPONI
肿瘤坏死因子拮抗剂。

制造商SIMPONI
Centocor Ortho生技公司公司
适应症SIMPONI
中度至严重活动性类风湿关节炎（RA），与甲氨蝶呤联合（MTX）的。主动银屑病关节炎（PSA）的，单独或与甲氨蝶呤。活动期强直性脊柱炎（AS）。


成人剂量SIMPONI
资深大律师每月一次50毫克。旋转的网站。

儿童剂量为SIMPONI
“18yrs：不推荐。

警告/注意事项的SIMPONI
风险增加严重或致命的感染（如结核病，细菌性败血症，侵入性真菌）。主动感染：不主动治疗。长期或经常性或机会性感染的历史。条件，易患感染。旅游，或居住在，与TB或真菌病流行地区。测试和治疗潜伏性结核病开始治疗之前。密切监测，如果新的感染，乙型肝炎病毒（HBV）的，或血液恶液质恢复发展;停止，如果严重或机会性感染，败血症，乙肝病毒再激活，新的或恶化瑞士法郎，或血液异常（如血细胞减少）的发展。瑞士法郎（监视器）。免疫抑制。中枢神经系统脱髓鞘疾病。恶性肿瘤。乳胶过敏。老人。妊娠（Cat.B）。哺乳母亲：不推荐。

互作SIMPONI
并行阿贝西普，anakinra的，活疫苗，或其他肿瘤坏死因子阻断剂：不推荐。免疫抑制剂的感染风险增加。细胞色素P450显示器基板治疗指数狭窄。

不良反应为SIMPONI
注射液部位反应，感染（可能是严重），上呼吸道感染，鼻咽炎，高血压;罕见：恶性肿瘤（如淋巴瘤，尤指儿童），血液恶液质，新的或恶化心衰，肝酶升高，抗体的形成，加重或新银屑病的发病。

如何SIMPONI提供？
单剂量SmartJect自动注射器- 1，单剂量预充式注射器- 1

SIMPONI

Generic Name for SIMPONI

Golimumab 50mg/0.5mL; soln for SC inj; preservative-free.

Legal Classification:

Rx

Pharmacological Class for SIMPONI

TNF blocker.

Manufacturer of SIMPONI

Centocor Ortho Biotech Inc.

Indications for SIMPONI

Moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX). Active psoriatic arthritis (PsA), alone or with MTX. Active ankylosing spondylitis (AS).

Adult dose for SIMPONI

50mg SC once monthly. Rotate sites.

Children's dosing for SIMPONI

<18yrs: not recommended.

Warnings/Precautions for SIMPONI

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal). Active infections: do not initiate therapy. Chronic or history of recurring or opportunistic infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test for and treat latent TB prior to initiating therapy. Monitor closely if new infection, reactivation of hepatitis B virus (HBV), or blood dyscrasias develop; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, new or worsening CHF, or hematological abnormality (eg, cytopenias) develops. CHF (monitor). Immunosuppression. CNS demyelinating disorders. Malignancies. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions for SIMPONI

Concurrent abatacept, anakinra, live vaccines, or other TNF blockers: not recommended. Immunosuppressants increase risk of infection. Monitor CYP450 substrates with narrow therapeutic index.

Adverse Reactions for SIMPONI

Inj site reactions, infections (may be serious), upper respiratory tract infection, nasopharyngitis, hypertension; rare: malignancies (eg, lymphoma, esp children), blood dyscrasias, new or worsening CHF, elevated liver enzymes, antibody formation, exacerbation or new onset of psoriasis.

How is SIMPONI supplied?

Single-dose SmartJect autoinjector—1; Single-dose prefilled syringe—1