藥品異動通知2024.02.19 藥品新增 <10E175> Etanercept (Erelzi ®) (50mg/ml,1ml).pen 新藥介紹 <10E175> Etanercept (Erelzi ®) (50mg/ml,1ml).pen 藥理作用/作用機轉 Etanercept is a recombinant DNA-derived protein composed of tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. Etanercept binds tumor necrosis factor (TNF) and blocks its interaction with cell surface receptors. 適應症/ 劑量 SC 【Adult】 ●Ankylosing spondylitis: 50 mg Q1W or 25mg BIW. ●Plaque psoriasis, moderate to severe: Initial: 50 mg BIW for 3 months. Maintenance dose: 50 mg Q1W. ●Psoriatic arthritis: 50 mg Q1W or 25mg BIW. ●Rheumatoid arthritis: 50 mg Q1W or 25mg BIW. 【Pediatric】Children ≥2 years and Adolescents <18 years: ●Juvenile idiopathic arthritis: 0.8 mg/kg/dose Q1W(maximum dose: 50 mg Q1W or 25mg BIW). 【Geriatric】Refer to adult dosing. 『Renal Impairment: Adult』 No dosage adjustment necessary 『Hepatic Impairment: Adult』 No dosage adjustment necessary 使用禁忌 Sepsis, hypersensitivity to etanercept or any component of the formulation 警告/預防 Anaphylaxis/hypersensitivity reactions, Antibody formation, Autoimmune disorder, Demyelinating CNS disease, Heart failure, Hematologic disorders, Hepatitis B, Infections, Malignancy, Tuberculosis 不良反應 Adverse Reactions (Significant): Autoimmune disorder, Demyelinating disease, Dermatologic reactions, Heart failure, Hepatitis B reactivation, Hepatotoxicity, Infection, Injection-site reactions, Malignancy, Tuberculosis 【>10%】Skin rash, Diarrhea, Positive ANA titer, Antibody development, Infection, Injection-site reaction, Respiratory tract infection, upper respiratory tract infection 【1% to 10%】 Pruritus, urticaria, Hypersensitivity reaction, Fever 【<1%】Heart failure, aplastic anemia, leukemia, malignant lymphoma, pancytopenia, autoimmune hepatitis, Reactivation of HBV, varicella zoster infection, aseptic meningitis, demyelinating disease of the central nervous system, Lupus-like syndrome, tuberculosis 【Frequency not defined】 懷孕用藥分級(FDA) B /可能安全 健保規範 藥品說明:(比照10E081) 1)需事前審查核准後使用;使用本類藥品之醫事機構應注意監測病患用藥後之不良反應及可能發生的重大安全事件(如肺結核及病毒性肝炎)(103/9/1)。2)乾癬治療:每六月申請,療效須達PASI50方可續用,其它詳見健保規定8.2.4.6(104/04/01) 藥品理由: 01)(需專審)4歲以上的兒童具有活動性多關節幼年型慢性關節炎患者 02)(需專審)成人類風濕關節炎 03)(需專審)僵直性脊椎炎 04)(需專審)經照光及其他治療無效,或無法接受其他治療之全身慢性中、重度之乾癬或頑固之掌蹠性乾癬 05)(需專審)乾癬性周邊關節炎 06)(需專審)乾癬性脊椎病變 其他 核對用法: SC 注射部位:腹部,大腿,手臂外側 請先回至室溫(至少15分鐘)再行注射 筆針與注射部位呈垂直後施打,第二聲喀聲後停留5-10秒 室溫(25°C)可保存四週,不可回冰 育齡婦女治療期間與停藥3週內需行避孕措施 不適用於未滿6歲的幼年乾癬。
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.
藥品異動通知2024.02.02 藥品新增 <27D235> Drospirenone/Estetrol Monohydrate (Alyssa®).自費.錠 新藥介紹 <27D235> Drospirenone/Estetrol Monohydrate (Alyssa®).自費.錠 藥理作用/作用機轉 Combination hormonal contraceptives prevent pregnancy by suppressing ovulation. Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity. Estetrol is a synthetic analogue of a natural estrogen synthesized by the fetal liver and present only during pregnancy. It is not metabolized to estradiol or estriol. 適應症/ 劑量 PO 【Adult】 ●Contraception: 1 tablet QD in the order presented on the blister pack. For patients not currently using a hormonal contraceptive, the first active tablet should be taken on the first day of the menstrual cycle (day 1 start). 【Pediatric】Postmenarche patients ●Contraception: One tablet QD in the order presented on the blister pack. For patients not currently using a hormonal contraceptive, the first active tablet should be taken on the first day of the menstrual cycle (day 1 start). 【Geriatric】Refer to adult dosing. 『Renal Impairment: Adult』 Use is contraindicated 『Hepatic Impairment: Adult』 Use is contraindicated 使用禁忌 Hormonally sensitive malignancy, undiagnosed abnormal uterine bleeding, hepatic adenoma, hepatocellular carcinoma, acute hepatitis, severe (decompensated) cirrhosis, use of ombitasvir/paritaprevir/ritonavir with or without dasabuvir, adrenal insufficiency, kidney impairment. 警告/預防 Bleeding irregularities, cervical cancer, chloasma, cholestasis, hepatic adenomas or carcinomas, hyperkalemia, lipid effects, retinal thrombosis, thromboembolic disorders. 不良反應 【>10%】Gynecological bleeding, mood disorder 【1% to 10%】Acne vulgaris, breast changes, decreased libido, loss of libido, weight gain, dysmenorrhea , depression, headache 【<1%】Thromboembolic complications, hyperkalemia 懷孕用藥分級(FDA) D /避免使用 健保規範 藥品說明: 藥品理由: 其他 粉紅色有效藥錠:15 mg Estetrol Monohydrate (E4) (等同14.2 mg的Estetrol) and 3 mg Drospirenone (DRSP)。 白色無作用藥錠:該藥錠不含有效成分。 應依照鋁箔標示順序使用。 漏服補服方法請見仿單 避免用於抽菸且35歲以上之女性。 偏頭痛狀況若加劇請回診告知醫師。 執行大型手術請提前告知醫師用藥史。