藥碼
LEN05
藥名
Lenvatinib 膠囊 高 10 mg
英文商品名
事審 Lenvima 膠囊 紫紅 高 10 mg
中文商品名
樂衛瑪膠囊10毫克
螢幕名
事審 Lenvima 膠囊 紫紅 高 10 mg
劑型
Cap
規格
成分
藥理分類
Antineoplastic Drugs
健保碼
BC26934100
ATC碼
藥品圖片
外觀圖片
適應症
Hepatocellular carcinoma, unresectableRenal cell carcinoma, advancedThyroid cancer, differentiated
藥理
Lenvatinib is a multitargeted tyrosine kinase inhibitor of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), VEGFR3 (FLT4), fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. Inhibition of these receptor tyrosine kinases leads to decreased tumor growth and slowing of cancer progression. In hepatocellular carcinoma cell lines dependent on activated FGFR signaling (with a concurrent inhibition of FGF-receptor substrate 2α phosphorylation), lenvatinib exhibited antiproliferative activity. Combining lenvatinib with everolimus has demonstrated increased antiangiogenic and antitumor activity by decreasing human endothelial cell proliferation, tube formation, and VEGF signaling (in vitro) compared to either drug alone.
藥動學
Absorption:
1. Tmax, oral: 1 to 4 hours
2. Effects of food: Delayed Tmax by 2 hours; delayed the rate but not the extent of absorption
Distribution:
Protein binding: 98-99%
Metabolism:
Liver; Substrate of CYP3A, P-gp, and BCRP
Excretion:
1. Renal: 25%; Fecal: 64%
2. Elimination Half Life:28 hours
禁忌症
Hypersensitivity to lenvatinib or any component of the formulation.
懷孕分類
Based on the mechanism of action and findings from animal reproduction studies, lenvatinib may cause fetal harm if administered in pregnancy. Verify pregnancy status prior to initiating lenvatinib in females of reproductive potential. Females of reproductive potential should use effective contraception during lenvatinib treatment and for at least 30 days after completion of therapy. Lenvatinib may impair fertility in males and females of reproductive potential.
哺乳分類
Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends discontinuing breastfeeding during lenvatinib treatment and for at least 1 week after the last lenvatinib dose.
副作用
Common:
1. Cardiovascular: Hypertension, Peripheral edema
2. Dermatologic: Hand-foot syndrome due to cytotoxic therapy, Impaired wound healing, Rash
3. Gastrointestinal: Abdominal pain, Decrease in appetite, Nausea, Stomatitis, Weight decreased
4. Musculoskeletal: Arthralgia, Myalgia
5. Neurologic: Headache
6. Renal: Proteinuria
7. Respiratory: Cough
8. Other: Difficulty speaking, Fatigue
Serious:
1. Cardiovascular: Myocardial dysfunction, Prolonged QT interval
2. Gastrointestinal: Diarrhea, Vomiting
3. Hematologic: Anemia, Arterial thrombosis, Thrombocytopenia
4. Hepatic: Hepatic encephalopathy, Hepatitis, Hepatorenal syndrome, Liver failure
5. Renal: Renal failure, Renal impairment
6. Respiratory: Dyspnea
7. Other: Dehydration
劑量和給藥方法
Hepatocellular carcinoma, unresectable:
12 mg once daily (patients ≥60 kg [actual body weight]) or 8 mg once daily (patients <60 kg [actual body weight]) continue until disease progression or unacceptable toxicity
Renal cell carcinoma, advanced:
18 mg once daily (in combination with everolimus), continue until disease progression or unacceptable toxicity
Thyroid cancer, differentiated:
24 mg once daily until disease progression or unacceptable toxicity
小兒調整劑量
腎功能調整劑量
Preexisting renal impairment:
1. CrCl ≥30 mL/min: No dosage adjustment necessary
2. CrCl <30 mL/min:
(1) Hepatocellular carcinoma: There are no dosage adjustments provided in the manufacturer's labeling.
(2) Renal cell cancer, advanced: 10 mg once daily
(3) Thyroid cancer, differentiated: 14 mg once daily
3. ESRD: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
4. Hemodialysis: Lenvatinib is not expected to be dialyzable (due to high protein binding)
Renal toxicity during treatment:
1. Nephrotic syndrome: Permanently discontinue therapy
2. Proteinuria ≥2 g proteinuria/24 hours: Withhold therapy; resume therapy at a reduced dose when improved to <2 g proteinuria/24 hours
3. Renal failure or impairment (grade 3 or 4): Withhold therapy; if improves to ≤grade 1 or baseline, depending on the severity and persistence, resume at a reduced dose or permanently discontinue therapy.
肝功能調整劑量
1. Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
2. Moderate impairment (Child-Pugh class B): There are no dosage adjustments provided in the manufacturer's labeling.
3. Severe impairment (Child-Pugh class C):
(1) Hepatocellular carcinoma, unresectable: There are no dosage adjustments provided in the manufacturer's labeling.
(2) Renal cell cancer, advanced: 10 mg once daily
(3) Thyroid cancer, differentiated: 14 mg once daily
(4) Hepatotoxicity during treatment (grade 3 or 4): Withhold therapy; if improves to ≤grade 1 or baseline, resume at a reduced dose or permanently discontinue therapy
安定性
藥袋資訊
臨床用途
化學治療藥
主要副作用
高血壓、心臟功能障礙、動脈血管栓塞、肝腎功能異常、腹瀉、低血鈣、蛋白尿、出血、關節痛
泡製方法
儲存方式
請置於 15-30℃ 乾燥處儲存
注意事項
其他說明
藥局 Y3 | 藥庫 口D21
藥品外觀
顏色
04
05
形狀
13
剝痕
N
標記1
LENV 10mg
標記2
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其他
健保藥價
967
自費價
1286.11
仿單
資料庫
健保給付規定