藥碼
IMJ01
藥名
Tremelimumab 20 mg/mL, 15 mL/Vial
英文商品名
化臨採 Imjudo 針 300 mg/15 mL
中文商品名
抑佳妥注射劑
螢幕名
化臨採 Imjudo 針 300 mg/15 mL
劑型
Inj
規格
成分
藥理分類
Anticancer- Monoclonal antibodies
健保碼
KC01242235
ATC碼
適應症
| #高警訊藥品 |
成人不可切除的肝細胞癌 Hepatocellular carcinoma, unresectable、成人轉移性非小細胞肺癌 Non–small cell lung cancer, metastatic
藥理
Antineoplastic Agent, Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking human IgG2 monoclonal antibody
CTLA-4 is a negative regulator of T-cell activity. Tremelimumab binds to CTLA-4 and blocks interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation. In animal tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T-cells in tumors.
CTLA-4 is a negative regulator of T-cell activity. Tremelimumab binds to CTLA-4 and blocks interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation. In animal tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T-cells in tumors.
藥動學
禁忌症
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to tremelimumab or any component of the formulation.
Canadian labeling: Hypersensitivity to tremelimumab or any component of the formulation.
懷孕分類
C; Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and GA, generally increasing as pregnancy progresses.
哺乳分類
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for 3 months after the last tremelimumab dose.
副作用
Pruritus (23%), skin rash (≦32%); Decreased serum albumin (31%), decreased serum calcium (34%), decreased serum sodium (46%), increased serum glucose (39%), increased serum potassium (28%); Abdominal pain (20%), diarrhea (≦27%); Decreased hemoglobin (52%) decreased platelet count (29%), leukopenia (20%), lymphocytopenia (41%); Increased serum alanine aminotransferase (56%), increased serum alkaline phosphatase (41%), increased serum aspartate aminotransferase (63%), increased serum bilirubin (41%); Fatigue (26%); Musculoskeletal pain (22%); Increased serum creatinine (21%)
劑量和給藥方法
Hepatocellular carcinoma, unresectable:
Patients ≧30 kg: IV: 300 mg on day 1 of cycle 1 only (in combination with durvalumab), followed by urvalumab monotherapy until disease progression or unacceptable toxicity.
Patients <30 kg: IV: 4 mg/kg on day 1 of cycle 1 only (in combination with durvalumab), followed by durvalumab monotherapy until disease progression or unacceptable toxicity.
Non–small cell lung cancer, metastatic:
Patients ≧30 kg:
Cycles 1-4: IV: 75 mg on day 1 every 3 weeks for cycles 1 through 4 (in combination with durvalumab and platinum-based chemotherapy).
Cycle 5: No tremelimumab dose is administered. Durvalumab is administered during cycle 5; refer to durvalumab monograph for durvalumab dosing schedule.
Cycle 6: IV: 75 mg on day 1 (in combination with durvalumab); cycle 6 begins at week 16 (there is a 4-week interval between cycles 5 and 6). After cycle 6, continue durvalumab until disease progression or unacceptable toxicity.
Patients <30 kg:
Cycles 1-4: IV: 1 mg/kg on day 1 every 3 weeks for cycles 1 through 4 (in combination with durvalumab and platinum-based chemotherapy).
Cycle 5: No tremelimumab dose is administered. Durvalumab is administered during cycle 5; refer to durvalumab monograph for durvalumab dosing schedule.
Cycle 6: IV: 1 mg/kg on day 1 (in combination with durvalumab); cycle 6 begins at week 16 (there is a 4-week interval between cycles 5 and 6). After cycle 6, continue durvalumab until disease progression or unacceptable toxicity.
Patients ≧30 kg: IV: 300 mg on day 1 of cycle 1 only (in combination with durvalumab), followed by urvalumab monotherapy until disease progression or unacceptable toxicity.
Patients <30 kg: IV: 4 mg/kg on day 1 of cycle 1 only (in combination with durvalumab), followed by durvalumab monotherapy until disease progression or unacceptable toxicity.
Non–small cell lung cancer, metastatic:
Patients ≧30 kg:
Cycles 1-4: IV: 75 mg on day 1 every 3 weeks for cycles 1 through 4 (in combination with durvalumab and platinum-based chemotherapy).
Cycle 5: No tremelimumab dose is administered. Durvalumab is administered during cycle 5; refer to durvalumab monograph for durvalumab dosing schedule.
Cycle 6: IV: 75 mg on day 1 (in combination with durvalumab); cycle 6 begins at week 16 (there is a 4-week interval between cycles 5 and 6). After cycle 6, continue durvalumab until disease progression or unacceptable toxicity.
Patients <30 kg:
Cycles 1-4: IV: 1 mg/kg on day 1 every 3 weeks for cycles 1 through 4 (in combination with durvalumab and platinum-based chemotherapy).
Cycle 5: No tremelimumab dose is administered. Durvalumab is administered during cycle 5; refer to durvalumab monograph for durvalumab dosing schedule.
Cycle 6: IV: 1 mg/kg on day 1 (in combination with durvalumab); cycle 6 begins at week 16 (there is a 4-week interval between cycles 5 and 6). After cycle 6, continue durvalumab until disease progression or unacceptable toxicity.
小兒調整劑量
腎功能調整劑量
There are no dosage adjustments provided in the manufacturer's labeling.
肝功能調整劑量
There are no dosage adjustments provided in the manufacturer's labeling.
安定性
1. Store intact vials at 2°C to 8°C; do not freeze. Protect from light. Do not shake.
2. Solutions diluted for infusion should be used immediately after preparation.
3. If not administered immediately, may be stored (from the time of preparation to the start of infusion) for up to 24 hours refrigerated at 2°C to 8°C or at room temperature up to 30°C.
4. Do not freeze or shake diluted solution.
2. Solutions diluted for infusion should be used immediately after preparation.
3. If not administered immediately, may be stored (from the time of preparation to the start of infusion) for up to 24 hours refrigerated at 2°C to 8°C or at room temperature up to 30°C.
4. Do not freeze or shake diluted solution.
藥袋資訊
臨床用途
未曾接受全身性療法之晚期或無法切除之肝細胞癌成人病人
主要副作用
腹瀉、腹痛、皮疹、疲倦、食慾減低
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 化 藥庫 化療
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
348764
自費價
383640.4
仿單
資料庫
健保給付規定
## 資料使用與著作權聲明 本網站提供之藥品資訊，主要供醫療照護、藥事服務、衛教及一般資訊查詢使用。網站內容包含藥品名稱、成分、劑型、規格、適應症、使用方式、劑量、注意事項及其他相關資訊，實際內容依各藥品資料來源及本院資料建置情形而定。 一、醫療使用聲明 本網站所提供之藥品資訊僅供參考，不應單獨作為診斷、治療、處方調整、停藥或自行用藥之依據。 藥品之實際適應症、使用方法、使用劑量、使用頻率、療程及相關注意事項，應依個別病人之病情、年齡、肝腎功能、合併用藥及其他臨床狀況，由醫師或其他具資格之醫療專業人員進行專業判斷。 病人實際使用藥品時，請以醫師處方、藥袋標示及醫療專業人員之指示為依歸。請勿僅依本網站資訊自行增加、減少、停止或改變藥品使用方式及劑量。 如網站資訊與醫師處方、藥袋標示或醫療專業人員指示有所不同，應優先依醫師處方及醫療專業人員之個別指示使用。 二、資料來源與更新 本網站藥品資訊參考藥品資訊資料庫、主管機關核准之藥品仿單、藥品許可證資料、藥品製造或供應廠商提供之資料、本院藥品管理資料，以及其他經評估之專業資訊來源。 藥品資訊可能因主管機關核准內容、藥品許可證、仿單、供應狀況或臨床建議更新而有所變動，本網站將依實際作業情形進行維護與更新。 如需確認最新藥品核准資訊，應以主管機關公告、最新版藥品仿單及醫療專業人員判斷為準。 三、資料使用範圍 本網站內容可供個人查詢、醫療照護、衛教及非商業性學習使用。 使用者引用或轉載本網站內容時，應註明資料來源，並保留原有內容之完整性及必要之醫療警語，不得任意變更、變更原意或其他可能造成錯誤醫療理解之方式使用。 未經授權，不得將本網站內容大量重製、建立資料庫、進行商業性再利用，或以其他方式侵害相關著作權或其他權利。 四、著作權及第三方資料 本網站由本院自行製作之文字、編排、圖表、圖示及其他內容，其著作權或相關權利依著作權法及其他相關法令受到保護。 網站中引用之藥品仿單、藥品圖片、商標、產品名稱、主管機關資料或其他第三方資料，其著作權、商標權或其他相關權利仍歸原權利人所有。 本網站對第三方資料之使用，以醫療資訊提供、教育、研究或其他合法使用目的為原則，相關權利仍應依原資料來源及相關法令辦理。 五、責任範圍 本網站致力於維持資料之正確性與完整性，但藥品資訊可能隨核准事項、臨床資訊及供應狀況變更。 使用者因個別疾病、用藥或治療問題需要醫療判斷時，應洽詢醫師、藥師或其他適當之醫療專業人員。 本網站提供之一般性藥品資訊，無法取代醫療專業人員依個別病人狀況所作之醫療評估、處方及用藥指導。 六、聲明內容之調整 本院得依相關法令、資料來源、網站功能及實際作業需要，適時修訂本聲明內容。