藥碼
LIB01
藥名
Cemiplimab 50 mg/mL, 7 mL/Vial
英文商品名
化療臨採 Libtayo 針 350 mg
中文商品名
力汰瘤濃縮輸注液
螢幕名
化療臨採 Libtayo 針 350 mg/7 mL
劑型
Inj
規格
成分
藥理分類
Anticancer- Monoclonal antibodies
健保碼
KC01233224
ATC碼
適應症
| #高警訊藥品 |
Basal cell carcinoma, locally advanced or metastatic:
Treatment (as a single agent) of locally advanced or metastatic basal cell carcinoma in adults previously treated with a hedgehog pathway inhibitor or when a hedgehog pathway inhibitor is not appropriate.
Cutaneous squamous cell carcinoma:
Adjuvant treatment (as a single agent) of cutaneous squamous cell carcinoma (cSCC) in adults at high risk of recurrence following surgery and radiation.
Treatment (as a single agent) of metastatic cSCC or locally advanced cSCC in adults who are not candidates for curative surgery or curative radiation.
Non–small cell lung cancer, locally advanced or metastatic:
1. First-line treatment (as a single agent) of non–small cell lung cancer in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] 50%) as determined by an approved test, with no EGFR, ALK, or ROS1 aberrations, and with locally advanced (in patients who are not candidates for surgical resection or definitive chemoradiation) or metastatic disease.
2. First-line treatment (in combination with platinum-based chemotherapy) of non–small cell lung cancer in adults whose tumors have no EGFR, ALK, or ROS1 aberrations, and with locally advanced (in patients who are not candidates for surgical resection or definitive chemoradiation) or metastatic disease.
藥理
Antineoplastic Agent, Anti-PD-1 Monoclonal Antibody; Immune Checkpoint Inhibitor; Monoclonal Antibody
Cemiplimab is a recombinant human IgG4 monoclonal antibody that inhibits programmed death-1 (PD-1) activity by binding to PD-1 and blocking the interactions with the ligands PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of immune response, including anti-tumor response.
Cemiplimab is a recombinant human IgG4 monoclonal antibody that inhibits programmed death-1 (PD-1) activity by binding to PD-1 and blocking the interactions with the ligands PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of immune response, including anti-tumor response.
藥動學
禁忌症
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Hypersensitivity to cemiplimab or any component of the formulation.
Canadian labeling: Hypersensitivity to cemiplimab 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 adverse events in the breastfed infant, the manufacturer does not recommended breastfeeding during therapy or for at least 4 months after the last cemiplimab dose.
副作用
Hypertension (17%), pruritus (16% to 22%), skin rash (15% to 37%), diarrhea (26% to 33%), nausea (13% to 21%), fatigue (14% to 50%), Musculoskeletal pain (26% to 36%), upper respiratory tract infection (14% to 22%).
劑量和給藥方法
Basal cell carcinoma, locally advanced or metastatic:
IV: 350 mg once every 3 weeks; continue until disease progression, unacceptable toxicity, or up to 24 months.
Cutaneous squamous cell carcinoma, adjuvant treatment:
IV: 350 mg once every 3 weeks for 4 doses, followed by 700 mg once every 6 weeks or 350 mg every 3 weeks; continue until disease recurrence, unacceptable toxicity, or up to 48 weeks.
Cutaneous squamous cell carcinoma, metastatic or locally advanced:
IV: 350 mg once every 3 weeks; continue until disease progression, unacceptable toxicity, or up to 24 months.
Non–small cell lung cancer, locally advanced or metastatic, with PD-L1 expression:
IV: 350 mg once every 3 weeks; continue until disease progression or unacceptable toxicity.
Non–small cell lung cancer, locally advanced or metastatic:
IV: 350 mg once every 3 weeks (in combination with up to 4 cycles of platinum-based chemotherapy); continue until disease progression or unacceptable toxicity, or for up to 108 weeks.
IV: 350 mg once every 3 weeks; continue until disease progression, unacceptable toxicity, or up to 24 months.
Cutaneous squamous cell carcinoma, adjuvant treatment:
IV: 350 mg once every 3 weeks for 4 doses, followed by 700 mg once every 6 weeks or 350 mg every 3 weeks; continue until disease recurrence, unacceptable toxicity, or up to 48 weeks.
Cutaneous squamous cell carcinoma, metastatic or locally advanced:
IV: 350 mg once every 3 weeks; continue until disease progression, unacceptable toxicity, or up to 24 months.
Non–small cell lung cancer, locally advanced or metastatic, with PD-L1 expression:
IV: 350 mg once every 3 weeks; continue until disease progression or unacceptable toxicity.
Non–small cell lung cancer, locally advanced or metastatic:
IV: 350 mg once every 3 weeks (in combination with up to 4 cycles of platinum-based chemotherapy); continue until disease progression or unacceptable toxicity, or for up to 108 weeks.
小兒調整劑量
腎功能調整劑量
(Prior to treatment initiation) There are no dosage adjustments provided in the manufacturer's labeling; however, no clinically significant differences in cemiplimab pharmacokinetics were observed in patients with kidney impairment.
肝功能調整劑量
(Prior to treatment initiation) There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
安定性
1. Store intact vials at 2°C to 8°C; do not freeze.
2. Store in the original carton. Protect from light. Do not shake.
3. If not used immediately, solutions diluted for infusion should be stored at up to 25°C for no more than 8 hours (from the time of preparation to the end of the infusion) or at 2°C to 8°C for no more than 10 days (from the time of preparation to the end of infusion).
4. Do not freeze. Do not shake. Allow the diluted solution to reach room temperature prior to administration.
2. Store in the original carton. Protect from light. Do not shake.
3. If not used immediately, solutions diluted for infusion should be stored at up to 25°C for no more than 8 hours (from the time of preparation to the end of the infusion) or at 2°C to 8°C for no more than 10 days (from the time of preparation to the end of infusion).
4. Do not freeze. Do not shake. Allow the diluted solution to reach room temperature prior to administration.
藥袋資訊
臨床用途
皮膚鱗狀細胞癌、基底細胞癌、非小細胞肺癌、子宮頸癌
主要副作用
貧血、頭痛、食慾減少、腹瀉、噁心、腹痛、疲倦
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
94591
自費價
104050.1
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。