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新药simponi再获治疗活动性银屑病关节炎新适应证

2010-12-10 12:27:53 作者：新特药房来源：中国新特药网天津分站浏览次数：230 文字大小：【大】【中】【小】

简介： 人源性单克隆抗体药simponi 是用于治疗成人中至重度类风湿关节炎（RA）、银屑病关节炎（PsA）及强直性脊柱炎（AS）的长效药物。最近，强生公司向美国FDA递交Simponi的最新适应症，即用于治疗活动性银屑病 ...

人源性单克隆抗体药simponi 是用于治疗成人中至重度类风湿关节炎（RA）、银屑病关节炎（PsA）及强直性脊柱炎（AS）的长效药物。最近，强生公司向美国FDA递交Simponi的最新适应症，即用于治疗活动性银屑病关节炎（PsA）。具体的申请文件由其合作伙伴美国默克制药公司递交。

申请依据是在一项名为GO-REVEAL的临床实验中获取的数据。今年9月份，人源性单克隆抗体药simponi作为防止结构损害疗法用于医治中-重度活动性风湿性关节炎（RA）的扩大适应症申请也已递交，这已是今年关于该药的第二份扩大适应症申请。

simponi 是强生公司研制的生物制品，在美国获准作为每月使用一次的抗肿瘤坏死因子α疗法药治疗中-重度活动性类风湿关节炎、银屑病关节炎和活动性强直性脊柱炎。simponi与免疫抑制剂甲氨蝶呤（MTX）联用治疗风湿关节炎，也可与甲氨蝶呤联用或单用治疗银屑病关节炎；单用于强直性脊柱炎治疗

SIMPONI

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

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.