藥碼
VYL01
藥名
Zolbetuximab 100 mg/5 mL
英文商品名
化療 臨採 Vyloy 針 100 mg
中文商品名
威絡益凍晶注射劑100毫克
螢幕名
化療 臨採 Vyloy 針 100 mg
劑型
Inj
規格
成分
藥理分類
Antineoplastic Drugs
健保碼
KC01278255
ATC碼
適應症
In combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive ((75% of tumor cells demonstrating moderate-to-strong membranous CLDN18 immunohistochemical staining), as determined by an FDA-approved test.
藥理
CLDN18.2-directed cytolytic monoclonal antibody; induces depletion of CLDN18.2-positive cells through ADCC and CDC.
藥動學
Steady-state volume of distribution: 14.0 L.
Metabolism: Expected to be catabolized into small peptides and amino acids.
Elimination: Clearance: 0.013 L/hr; terminal half-life: 41 days.
Metabolism: Expected to be catabolized into small peptides and amino acids.
Elimination: Clearance: 0.013 L/hr; terminal half-life: 41 days.
禁忌症
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to zolbetuximab or any component of the formulation.
Canadian labeling: Hypersensitivity to zolbetuximab or any component of the formulation.
懷孕分類
No adequate and well-controlled studies in pregnant women. VYLOY should be administered during pregnancy only if the potential benefit justifies the potential risk. Zolbetuximab-clzb crossed the placenta in animal studies.
哺乳分類
There are no data regarding the presence of zolbetuximab-clzb in human milk or its effects on the breastfed infant or milk production. Breastfeeding is not recommended during treatment and for 8 months after the last dose.
副作用
Common (≥15%) : nausea, vomiting, fatigue, decreased appetite, diarrhea, peripheral sensory neuropathy, abdominal pain, constipation, decreased weight, hypersensitivity reactions, and pyrexia.
Important serious adverse effects:
hypersensitivity reactions including anaphylaxis and infusion-related reactions; severe nausea and vomiting.
Laboratory abnormalities commonly include :
1. decreased neutrophils/leukocytes/lymphocytes
2. decreased albumin/hemoglobin/platelets
3. increased creatinine, AST, ALT, and alkaline phosphatase
4. decreased sodium, potassium, phosphate, and magnesium.
Important serious adverse effects:
hypersensitivity reactions including anaphylaxis and infusion-related reactions; severe nausea and vomiting.
Laboratory abnormalities commonly include :
1. decreased neutrophils/leukocytes/lymphocytes
2. decreased albumin/hemoglobin/platelets
3. increased creatinine, AST, ALT, and alkaline phosphatase
4. decreased sodium, potassium, phosphate, and magnesium.
劑量和給藥方法
IV infusion only; do not administer as IV push or bolus.
In combination with fluoropyrimidine- and platinum-containing chemotherapy :
First dose : 800 mg/m2 IV.
Subsequent doses : 600 mg/m2 IV every 3 weeks or 400 mg/m2 IV every 2 weeks.
Continue until disease progression or unacceptable toxicity.
Premedicate with antiemetics before each infusion. If administered on the same day as chemotherapy, administer VYLOY before the chemotherapy.
In combination with fluoropyrimidine- and platinum-containing chemotherapy :
First dose : 800 mg/m2 IV.
Subsequent doses : 600 mg/m2 IV every 3 weeks or 400 mg/m2 IV every 2 weeks.
Continue until disease progression or unacceptable toxicity.
Premedicate with antiemetics before each infusion. If administered on the same day as chemotherapy, administer VYLOY before the chemotherapy.
小兒調整劑量
Not established. Safety and efficacy in pediatric patients have not been established.
腎功能調整劑量
No dose adjustment required for mild-to-moderate renal impairment (CrCl 30 to <90 mL/min). The effect of severe renal impairment (CrCl <30 mL/min) on zolbetuximab-clzb pharmacokinetics is unknown.
肝功能調整劑量
No dose adjustment required for mild hepatic impairment. The effect of moderate-to-severe hepatic impairment is unknown.
安定性
Store at 2–8°C (36–46°F) in the original carton. Do not freeze or shake.
After reconstitution : May be stored at 15–30°C for up to 5 hours if not used immediately.
After dilution : Store at 15–30°C for up to 6 hours from the end of preparation to completion of infusion, or refrigerated at 2–8°C for up to 16 hours. Do not freeze.
After reconstitution : May be stored at 15–30°C for up to 5 hours if not used immediately.
After dilution : Store at 15–30°C for up to 6 hours from the end of preparation to completion of infusion, or refrigerated at 2–8°C for up to 16 hours. Do not freeze.
注射給藥指引
給藥途徑
僅限靜脈輸注。不可進行靜脈推注或快速注射。
For intravenous infusion only. Do not administer as an intravenous push or bolus.靜脈輸注液
0.9% 氯化鈉注射液（生理食鹽水）。
0.9% Sodium Chloride Injection (Normal Saline).每瓶稀釋液體積
每瓶 100 毫克藥粉需使用 5 毫升注射用無菌水 (SWFI) 進行配製，使其最終濃度為 20 毫克/毫升。接著根據患者體表面積計算所需劑量，並將該體積加入 0.9% 氯化鈉注射液的輸注袋中使稀釋後濃度為 5mg/mL or 2mg/ml
注射濃度
給藥速率
首次輸注：前 30 分鐘應以預定速率之 20% 緩慢開始；若耐受良好，隨後 90 分鐘內以 100% 的預定速率完成輸注。後續輸注：若先前未發生顯著輸注相關反應，可在 60 至 120 分鐘內完成輸注。
Initial infusion: Start slowly at 20% of the target rate for the first 30 minutes; if well-tolerated, complete the remaining infusion at 100% of the rate over the next 90 minutes. Subsequent infusions: If no significant infusion-related reactions occurred previously, complete the infusion over 60 to 120 minutes.安定性
Store at 2–8°C (36–46°F) in the original carton. Do not freeze or shake.
After reconstitution : May be stored at 15–30°C for up to 5 hours if not used immediately.
After dilution : Store at 15–30°C for up to 6 hours from the end of preparation to completion of infusion, or refrigerated at 2–8°C for up to 16 hours. Do not freeze.
After reconstitution : May be stored at 15–30°C for up to 5 hours if not used immediately.
After dilution : Store at 15–30°C for up to 6 hours from the end of preparation to completion of infusion, or refrigerated at 2–8°C for up to 16 hours. Do not freeze.
注意事項
1. 輸注前建議預防性給予止吐劑與抗組織胺藥物。 2. 應嚴密監測輸注相關反應（IRR），最常見為噁心與嘔吐；若發生反應，應依嚴重程度調慢速率、暫停或永久停藥。 3. 本藥物僅適用於經檢測確認為 CLDN18.2 表現陽性之患者。 4. 給藥時需使用 0.2 或 0.22 微米的低蛋白結合線上過濾器。
1. Premedication with antiemetics and antihistamines is recommended prior to infusion. 2. Closely monitor for infusion-related reactions (IRR), with nausea and vomiting being most common; depending on severity, slow, interrupt, or permanently discontinue the infusion if a reaction occurs. 3. Use only in patients confirmed to have CLDN18.2-positive expression. 4. Administer using a 0.2 or 0.22 micron low protein-binding in-line filter.藥袋資訊
臨床用途
標靶治療劑
主要副作用
噁心、嘔吐、食慾減退、周邊水腫
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
11445
自費價
13161.75
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。