藥品新增

<10E175> Etanercept (Erelzi ®) (50mg/ml,1ml).pen

新藥介紹

<10E175> Etanercept (Erelzi ®) (50mg/ml,1ml).pen

藥理作用/作用機轉

Etanercept is a recombinant DNA-derived protein composed of tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. Etanercept binds tumor necrosis factor (TNF) and blocks its interaction with cell surface receptors.

適應症/

劑量

SC

【Adult】

　●Ankylosing spondylitis: 50 mg Q1W or 25mg BIW.

　●Plaque psoriasis, moderate to severe: Initial: 50 mg BIW for 3 months. Maintenance dose: 50 mg Q1W.

　●Psoriatic arthritis: 50 mg Q1W or 25mg BIW.

　●Rheumatoid arthritis: 50 mg Q1W or 25mg BIW.

【Pediatric】Children ≥2 years and Adolescents <18 years:

　●Juvenile idiopathic arthritis: 0.8 mg/kg/dose Q1W(maximum dose: 50 mg Q1W or 25mg BIW).

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

No dosage adjustment necessary

『Hepatic Impairment: Adult』

No dosage adjustment necessary

使用禁忌

Sepsis, hypersensitivity to etanercept or any component of the formulation

警告/預防

Anaphylaxis/hypersensitivity reactions, Antibody formation, Autoimmune disorder, Demyelinating CNS disease, Heart failure, Hematologic disorders, Hepatitis B, Infections, Malignancy, Tuberculosis

不良反應

Adverse Reactions (Significant): Autoimmune disorder, Demyelinating disease, Dermatologic reactions, Heart failure, Hepatitis B reactivation, Hepatotoxicity, Infection, Injection-site reactions, Malignancy, Tuberculosis

【>10%】Skin rash, Diarrhea, Positive ANA titer, Antibody development, Infection, Injection-site reaction, Respiratory tract infection, upper respiratory tract infection

【1% to 10%】 Pruritus, urticaria, Hypersensitivity reaction, Fever

【<1%】Heart failure, aplastic anemia, leukemia, malignant lymphoma, pancytopenia, autoimmune hepatitis, Reactivation of HBV, varicella zoster infection, aseptic meningitis, demyelinating disease of the central nervous system, Lupus-like syndrome, tuberculosis

【Frequency not defined】

懷孕用藥分級(FDA)

B /可能安全

健保規範

  • 藥品說明：(比照10E081) 1)需事前審查核准後使用；使用本類藥品之醫事機構應注意監測病患用藥後之不良反應及可能發生的重大安全事件(如肺結核及病毒性肝炎)（103/9/1）。2)乾癬治療:每六月申請,療效須達PASI50方可續用,其它詳見健保規定8.2.4.6(104/04/01)

  • 藥品理由：

01)(需專審)4歲以上的兒童具有活動性多關節幼年型慢性關節炎患者

02)(需專審)成人類風濕關節炎

03)(需專審)僵直性脊椎炎

04)(需專審)經照光及其他治療無效，或無法接受其他治療之全身慢性中、重度之乾癬或頑固之掌蹠性乾癬

05)(需專審)乾癬性周邊關節炎

06)(需專審)乾癬性脊椎病變

其他

核對用法: SC

注射部位:腹部,大腿,手臂外側

請先回至室溫(至少15分鐘)再行注射

筆針與注射部位呈垂直後施打,第二聲喀聲後停留5-10秒

室溫(25°C)可保存四週,不可回冰

育齡婦女治療期間與停藥3週內需行避孕措施

不適用於未滿6歲的幼年乾癬。