藥碼
ACT02
藥名
Tocilizumab 20 mg/mL, 4 mL/Vial
英文商品名
綠盒 事審 Actemra 針 80 mg/4 mL
中文商品名
安挺樂靜脈點滴注射劑
螢幕名
綠盒 事審 Actemra 針 80 mg/4 mL
劑型
Inj
規格
Inj. 80 mg/4ml/vial.
成分
藥理分類
Disease-Modifying Antirheumatic Agents
健保碼
X000246219
ATC碼
藥品圖片
外觀圖片
適應症
1. Treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
2. Treatment of active systemic juvenile idiopathic arthritis in patients 2 years and older.
3. Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years and older.
藥理

Antagonist of the interleukin-6 (IL-6) receptor. Endogenous IL-6 is induced by inflammatory stimuli and mediates a variety of immunological responses. Inhibition of IL-6 receptors by tocilizumab leads to a reduction in cytokine and acute phase reactant production. 

藥動學

Absorption: 100%; Elimination half life: terminal, single dose: 6.3 days (concentration-dependent; may be increased up to 13 days in adults at steady state)

禁忌症

Hypersensitivity to tocilizumab or any component of the formulation; serious infections; Active TB.

懷孕分類

C

哺乳分類

Excretion in breast milk unknown/not recommended

副作用

Headache, hypertension, nasopharyngitis, respiratory-tract infections, hypercholesterolaemia, and increased liver enzyme values; Conjunctivitis, dizziness, gastritis, mouth ulceration, pruritus, and rash.

劑量和給藥方法
1. COVID-19, hospitalized patients: IV: 8 mg/kg once (maximum dose: 800 mg) as part of an appropriate combination regimen; For use in hospitalized patients with significant oxygen requirements (eg, high-flow oxygen, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation) and those with lower but increasing oxygen requirements and evidence of systemic inflammation; Do not initiate if ANC <1,000/mm3, platelets <50,000/mm3, or ALT or AST >10 times ULN. <20231212>
2. Cytokine release syndrome: IV: 8 mg/kg once (maximum dose: 800 mg).
3. Giant cell arteritis (adjunctive agent) : IV: 6 mg/kg (maximum dose: 600 mg) once every 4 weeks in combination with glucocorticoids.
4. Kidney transplant, antibody-mediated rejection (off-label use) : IV: 8 mg/kg (maximum: 800 mg per dose) once every 4 weeks until resolution.
5. Kidney transplant, pretransplant desensitization (adjunctive agent) (off-label use) : IV: Months prior to transplant: 8 mg/kg once monthly as part of a combination regimen (eg, immune globulin).
6. Neuromyelitis optica, relapse prevention (alternative agent) (off-label use) : IV: 8 mg/kg once every 4 weeks.
7. Rheumatoid arthritis: IV: Initial: 4 mg/kg once every 4 weeks; may be increased to 8 mg/kg once every 4 weeks based on clinical response (maximum dose: 800 mg).
小兒調整劑量
腎功能調整劑量
肝功能調整劑量
Not recommended for use in patients with active hepatic disease or hepatic impairment.
安定性

Store unused vials in original packaging refrigerated between 2?C and 8?C, protect from light. 

注射給藥指引
給藥途徑
IV
靜脈輸注液
NS
每瓶稀釋液體積
注射濃度
1.體重<30公斤者: 使用50 mL生理食鹽水輸注袋或輸注瓶,稀釋成總體積50mL。 2.體重≧30公斤者:使用100 mL生理食鹽水輸注袋或輸注瓶,稀釋成總體積100mL。
給藥速率
> 60min,最初15分鐘10 mL/hr;不可 IV push
安定性

Store unused vials in original packaging refrigerated between 2?C and 8?C, protect from light. 

注意事項
  1. 避光冷藏,給藥品前需回溫,給藥前如發現有異物或變色,請勿使用。
  2. 先自生理食鹽水輸注袋或輸注瓶中抽出與Tocilizumab 所需劑量相等之體積,再自Tocilizumab藥瓶中抽出所需藥量打進輸注袋中,輕輕倒置注射袋使混合均勻,避免振搖產生泡沫。勿與其他藥品共用IV SET。
  3. Tocilizumab是一種抗人類介白素6 (IL-6)受體之單株抗體,屬免疫抑制劑;會增加嚴重感染的風險,使用前應執行TFDA公告之風險管理計畫。
藥袋資訊
臨床用途
類風濕性關節炎、全身性或多關節性幼年型原發性關節炎、新冠肺炎
主要副作用
上呼吸道感染、鼻咽炎、頭痛、高血壓、肝功能異常、腹瀉、上腹部痛
泡製方法
儲存方式
請置於 2-8℃ 冷藏儲存
注意事項
其他說明
門診 急首X4 藥庫 冰Y15
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
3613
自費價
4335.6
仿單
資料庫
健保給付規定