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.