藥品異動通知2024.02.15 藥品新增 <10S055> Sacituzumab govitecan( Trodelvy®) (180mg/V). 新藥介紹 <10S055> Sacituzumab govitecan( Trodelvy®) (180mg/V). 藥理作用/作用機轉 Sacituzumab govitecan is an antibody drug conjugate that consists of a humanized antitrophoblast cell-surface antigen 2 (Trop-2) monoclonal antibody coupled to the topoisomerase 1 inhibitor SN-38 via a cleavable linker. Trop-2 is a transmembrane glycoprotein that is highly expressed in many epithelial cancer cell surfaces. TROP-2 is associated with cancer cell growth and has been detected in breast cancer cells (including triple-negative breast cancer cells). Sacituzumab govitecan binds to Trop-2 and is internalized; SN-38 is released in tumors both intracellularly and in the tumor microenvironment, leading to DNA damage, apoptosis, and cell death. 適應症/ 劑量 IV 【Adult】 ●Breast cancer, triple negative, locally advanced or metastatic, relapsed or refractory: 10 mg/kg on days 1 and 8 of a 21-day treatment cycle (maximum: 10 mg/kg/dose); continue until disease progression or unacceptable toxicity. ●Breast cancer, locally advanced or metastatic, hormone receptor(+), HER2(-): 10 mg/kg on days 1 and 8 of a 21-day treatment cycle (maximum: 10 mg/kg/dose); continue until disease progression or unacceptable toxicity. ●Urothelial cancer, locally advanced or metastatic: 10 mg/kg on days 1 and 8 of a 21-day treatment cycle (maximum: 10 mg/kg/dose); continue until disease progression or unacceptable toxicity 【Pediatric】Safety and efficacy not established. 【Geriatric】Refer to adult dosing. 『Renal Impairment』 No dosage adjustment necessary 『Hepatic Impairment』 Total bilirubin ≤ ULN with AST > ULN or bilirubin >1 to 1.5 times ULN with any AST: No initial dosage adjustment necessary. 使用禁忌 Severe hypersensitivity to sacituzumab govitecan or any component of the formulation 警告/預防 Older age, 不良反應 Adverse Reactions (Significant): Bone marrow suppression, GI toxicity, Hypersensitivity 【>10%】Edema, alopecia, pruritus, skin rash, xeroderma,↓serum albumin/glucose/Mg/P+/K, dehydration,↑lactate dehydrogenase,↑serum albumin/glucose/P/K, weight loss, abdominal pain, constipation,↓appetite, diarrhea, dysgeusia, dyspepsia, nausea, stomatitis, vomiting, hematuria, UTI,↓hemoglobin/ platelet count/ neutrophils, eosinophilia, leukopenia, lymphocytopenia, prolonged partial thromboplastin time,↑serum alkaline phosphatase, ↑serum AST/ALT, hypersensitivity reaction, infection, dizziness, fatigue, headache, insomnia, neuropathy, arthralgia, back pain, limb pain, AKI,↓creatinine clearance,↑serum creatinine, cough, dyspnea, respiratory tract infection, URTI, fever 【1% to 10%】 Hypotension, venous thromboembolism, skin hyperpigmentation, hypocalcemia, hypokalemia, hyponatremia, colitis, intestinal obstruction, proteinuria, febrile neutropenia, antibody development, bacteremia, sepsis, pain, nasal congestion, pleural effusion, pneumonia, rhinorrhea 【<1%】Enteritis, anaphylaxis 懷孕用藥分級(FDA) X / 致畸胎性 健保規範 l 藥品說明:須使用過taxane類藥物至少1個療程。每次申請之療程以3個月為限,初次申請時需檢附ER、PR、HER2皆為陰性之檢測報告。 l 藥品理由: (需專審)已接受兩次以上全身性治療無效之無法切除的局部晚期/轉移性的三陰性乳癌成年病人 其他 核對用法:IV滴 以20 mL 0.9% NaCl溶液配製,最終濃度為10 mg/mL 以0.9% NaCl溶液稀釋,濃度範圍:1.1 -3.4 mg/mL 首次輸注時間:大於3小時;非首次若狀況允許可下調至1-3小時 輸液袋應避光。稀釋後冷藏避光保存最長24小時 治療期間及最後一次給藥後1個月內不要哺乳 治療期間以及最後一次給藥後6個月內採取有效的避孕措施 可能會損害育齡女性的生育能力 Withhold dose on day 1 of any cycle for ANC <1,500/mm3; withhold dose on day 8 of any cycle for ANC <1,000/mm3. Premedicate with antipyretics and H1/H2 antagonists prior to infusion; corticosteroids may be used if prior infusion-related reactions occurred. 上一篇 下一篇