藥碼
RYB02
藥名
Amivantamab 化臨採 針 350 mg/7 mL
英文商品名
Rybrevant 化臨採針 350 mg/7 mL
中文商品名
肺倍恩注射劑
螢幕名
化 Rybrevant 臨採針 350 mg/7 mL
劑型
Inj
規格
Amivantamab 化臨採 針 350 mg/7 mL
成分
藥理分類
Antineoplastic Drugs
健保碼
KC01177224
ATC碼
適應症
表皮生長因子受體 (EGFR) 外顯子20 插入突變的局部晚期或轉移性非小細胞肺癌 (NSCLC)
藥理
Antineoplastic Agent, Epidermal Growth Factor Receptor (EGFR) Inhibitor; Antineoplastic Agent, MET Inhibitor; Antineoplastic Agent, Monoclonal Antibody
藥動學
Distribution: 5.13 L.
Half-life elimination: 11.3 days.
Excretion: 360 mL/day.
Half-life elimination: 11.3 days.
Excretion: 360 mL/day.
禁忌症
Hypersensitivity to amivantamab or any component of the formulation.
懷孕分類
Based on the mechanism of action and data from animal models, in utero exposure to amivantamab may cause fetal harm.
哺乳分類
breastfeeding is not recommended by the manufacturer during therapy and for 3 months after the last amivantamab dose.
副作用
>10%: edema (27%), paronychia (50%), pruritus (18%), skin rash (84%), decreased serum albumin (79%), decreased serum magnesium (27%), decreased serum phosphate (33%), decreased serum potassium (26%), decreased serum sodium (27%), increased gamma-glutamyl transferase (27%), increased serum glucose (56%), constipation (23%), nausea (36%), stomatitis (26%), vomiting (22%), hemorrhage (19%), lymphocytopenia (36%), increased serum alanine aminotransferase (38%), increased serum alkaline phosphatase (53%), increased serum aspartate aminotransferase (33%), fatigue (33%), musculoskeletal pain (47%), increased serum creatinine (46%), cough (25%), dyspnea (37%), infusion related reaction (64%).
劑量和給藥方法
Non–small cell lung cancer, locally advanced or metastatic, with epidermal growth factor receptor exon 20 insertion mutation:
Patients <80 kg:
Week 1: IV: 1,050 mg split over days 1 and 2 (350 mg on day 1 and 700 mg on day 2).
Weeks 2 to 4: IV: 1,050 mg once weekly.
Subsequent infusions: IV: 1,050 mg once every 2 weeks (starting at week 5) until disease progression or unacceptable toxicity.
Patients ≥80 kg:
Week 1: IV: 1,400 mg split over days 1 and 2 (350 mg on day 1 and 1,050 mg on day 2).
Weeks 2 to 4: IV: 1,400 mg once weekly.
Subsequent infusions: IV: 1,400 mg once every 2 weeks (starting at week 5) until disease progression or unacceptable toxicity.
Suggested dose adjustments for Rybrevant adverse reactions
Patients <80 kg:
Week 1: IV: 1,050 mg split over days 1 and 2 (350 mg on day 1 and 700 mg on day 2).
Weeks 2 to 4: IV: 1,050 mg once weekly.
Subsequent infusions: IV: 1,050 mg once every 2 weeks (starting at week 5) until disease progression or unacceptable toxicity.
Patients ≥80 kg:
Week 1: IV: 1,400 mg split over days 1 and 2 (350 mg on day 1 and 1,050 mg on day 2).
Weeks 2 to 4: IV: 1,400 mg once weekly.
Subsequent infusions: IV: 1,400 mg once every 2 weeks (starting at week 5) until disease progression or unacceptable toxicity.
Suggested dose adjustments for Rybrevant adverse reactions
| baseline weight | first dose | first dose reduction | second dose reduction | third dose reduction |
|---|---|---|---|---|
| <80 kg | 1050mg | 700mg | 350mg | Discontinue amivantamab |
| ≥ 80kg | 1400mg | 1050mg | 700mg | Discontinue amivantamab |
小兒調整劑量
腎功能調整劑量
肝功能調整劑量
安定性
注射給藥指引
給藥途徑
僅供靜脈輸注使用。不可透過靜脈推注或快速注射給藥。
Intravenous infusion only. Do not administer as an intravenous push or bolus.靜脈輸注液
5% 葡萄糖注射液 (D5W) 或 0.9% 生理食鹽水 (NS)。
5% Dextrose Injection (D5W) or 0.9% Sodium Chloride Injection (NS).每瓶稀釋液體積
根據計算劑量抽取適量的藥液，加入 250 mL 的輸注袋中，使最終總體積維持在 250 mL。第一週的劑量需平分為兩天給藥。
Withdraw the required volume of drug and add it to a 250 mL infusion bag to achieve注射濃度
給藥速率
第一週（第 1 天與第 2 天）：起始速率為 50 mL/hr，若耐受良好可視情況調整。第二週起始速率可為 85 mL/hr及後續週期：若先前無輸注反應，起始速率可為 125 mL/hr。
Week 1 (Days 1 and 2): Initial rate is 50 mL/hr, which may be adjusted if well-tolerated. Week 2 and subsequent cycles: If no prior infusion-related reactions, the initial rate can be 125 mL/hr and increased to a maximum of 250 mL/hr.安定性
注意事項
輸注相關反應 (IRR) 極為常見，給藥前必須常規給予抗組織胺、退燒藥及皮質類固醇。治療期間應監測間質性肺病 (ILD) 及嚴重的皮膚毒性（如甲溝炎、皮疹）。患者應避免陽光過度曝曬並使用防曬措施。
Infusion-related reactions (IRR) are very common; premedication with antihistamines, antipyretics, and corticosteroids is mandatory. Monitor for signs of interstitial lung disease (ILD) and severe dermatologic toxicities (e.g., paronychia, rash). Patients should avoid excessive sun exposure and use sun protection.藥袋資訊
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主要副作用
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健保藥價
36000
自費價
41400
仿單
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