藥碼
ADC01
藥名
Brentuximab vedotin 50 mg/Vial
英文商品名
化療 Adcetris 事審針 50 mg/Vial
中文商品名
雅詩力凍晶注射劑
螢幕名
化療 Adcetris 事審針 50 mg/Vial
劑型
Inj
規格
50mg/vial
成分
藥理分類
Antineoplastic Drugs
健保碼
KC00964248
ATC碼
藥品圖片
外觀圖片
適應症
Anaplastic large T-cell systemic malignant lymphoma, After the failure of at least one multi-agent chemotherapy regimen.
Hodgkin's disease, after failure of autologous hematopoietic stem cell transplant (auto-HSCT) or after failure of at least 2 multiagent chemotherapy regimens in patients not eligible for auto-HSCT.
Hodgkin's disease, Consolidation therapy after autologous hematopoietic stem-cell transplantation (auto-HSCT).
藥理
Brentuximab vedotin is a CD30-directed antibody-drug conjugate (ADC) consisting of 3 components: the chimeric IgG1 antibody cAC10 which is specific for human CD30
藥動學
Antibody Drug Conjugate (ADC), Vd: 6 to 10 L; Protein binding, 68% to 82%; Metabolism: hepatic: limited via CYP3A4/5. Excretion: Renal excretion: up to 24%; Elimination Half Life: Antibody Drug Conjugate (ADC), 4 to 6 days.
禁忌症
Concomitant use with bleomycin.
懷孕分類
Based on the mechanism of action and on animal data, brentuximab vedotin may cause fetal harm if administered to a pregnant woman. In women of reproductive potential, verify pregnancy prior to treatment initiation. Women of reproductive potential and men with female partners of reproductive potential should avoid pregnancy during treatment and for at least 6 months after the final dose. Brentuximab vedotin treatment may compromise fertility in males.
哺乳分類
Does not recommend breast-feeding during treatment
副作用
Common:
Cardiovascular: Peripheral edema (4% to 16%)
Central nervous system: Peripheral neuropathy (54% to 67%), peripheral sensory neuropathy (2% to 56%; grade 3: 8% to 10%), fatigue (24% to 49%), pain (7% to 28%), peripheral motor neuropathy (4% to 23%; grade 3: 3% to 6%), headache (11% to 19%), insomnia (14% to 16%), dizziness (11% to 16%), chills (10% to 13%), anxiety (7% to 11%)
Dermatologic: Skin rash (27% to 31%), pruritus (12% to 19%), alopecia (13% to 14%), night sweats (9% to 12%)
Endocrine & metabolic: Weight loss (6% to 19%)
Gastrointestinal: Nausea (2% to 42%), diarrhea (20% to 36%), abdominal pain (3% to 25%), vomiting (3% to 22%), constipation (13% to 19%), decreased appetite (11% to 16%)
Hematologic & oncologic: Neutropenia (54% to 78%; grade 3: 12% to 30%; grade 4: 6% to 9%), anemia (27% to 52%; grade 3: 2% to 8%; grade 4: 4%), thrombocytopenia (16% to 41%; grade 3: 5% to 7%; grade 4: 2% to 5%), lymphadenopathy (10% to 11%)
Immunologic: Antibody development (antibrentuximab; transient: 30%; persistent: 7%)
Neuromuscular & skeletal: Arthralgia (9% to 19%), myalgia (11% to 17%), back pain (10% to 14%), muscle spasm (9% to 11%)
Respiratory: Upper respiratory tract infection (12% to 47%), cough (17% to 25%), dyspnea (13% to 19%), oropharyngeal pain (9% to 11%)
Miscellaneous: Fever (2% to 38%), infusion related reaction (12% to 15%)
劑量和給藥方法
Hodgkin lymphoma, relapsed or refractory: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until disease progression or unacceptable toxicities.
Hodgkin lymphoma, consolidation therapy after autologous hematopoietic stem cell transplantation (HSCT): IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity. Begin therapy within 4 to 6 weeks post HSCT or upon recovery from HSCT.
Systemic anaplastic large cell lymphoma (sALCL), refractory: IV: 1.8 mg/kg (maximum dose: 180 mg) every 3 weeks, continue until disease progression or unacceptable toxicities.
小兒調整劑量
腎功能調整劑量
Renal impairment, mild or moderate (CrCl 30 to 80 mL/min): No dosage adjustment required.
Renal impairment, severe (CrCl less than 30 mL/min): Avoid use.
肝功能調整劑量
Hepatic impairment, mild (Child-Pugh A): Reduce dose to 1.2 mg/kg (maximum, 120 mg)
Hepatic impairment, moderate to severe (Child-Pugh B or C): Avoid use.
安定性
注射給藥指引
給藥途徑
IV
靜脈輸注液
NS, D5W
每瓶稀釋液體積
注射濃度
給藥速率
Infuse over 30 minutes
安定性
注意事項
藥袋資訊
臨床用途
化學治療劑
主要副作用
貧血、白血球血小板減少、噁心、嘔吐、腹瀉、便秘、厭食、運動神經失調、掉頭髮、疲勞、發燒
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
83184
自費價
91502.4
仿單
資料庫
健保給付規定