藥碼
BOL01
藥名
Zoledronic acid 4 mg/Vial
英文商品名
Bolenic 針 4 mg/Vial
中文商品名
卓固尼靜脈凍晶注射劑4毫克
螢幕名
Bolenic 針 4 mg/Vial
劑型
Inj
規格
zoledronic acid 4mg/vial
成分
藥理分類
Bone Resorption Inhibitors
健保碼
AA52339219
ATC碼
適應症
Labled: Bone metastases(solid tumors), Hypercalcemia of malignancy, Multiple myeloma, Osteoporosis, Paget disease
Off-Label: Breast cancer, bone loss associated with aromatase inhibitor therapy in postmenopausal females; Breast cancer, early stage, adjuvant therapy in postmenopausal females; Prostate cancer, bone loss associated with androgen deprivation therapy
Off-Label: Breast cancer, bone loss associated with aromatase inhibitor therapy in postmenopausal females; Breast cancer, early stage, adjuvant therapy in postmenopausal females; Prostate cancer, bone loss associated with androgen deprivation therapy
藥理
Bisphosphonate Derivative
藥動學
Distribution: Binds to bone
Protein binding: 23% to 53%
Metabolism: Primarily eliminated intact via the kidney; metabolism not likely
Half-life elimination: Triphasic; Terminal: 146 hours
Excretion: Urine (39% ± 16% as unchanged drug) within 24 hours; feces (<3%)
Renal function impairment: Mild renal impairment (CrCl 50 to 80 mL/minute) increased AUC by an average of 15%. Moderate renal impairment (CrCl 30 to 50 mL/minute) increased AUC by an average of 43%. The risk of renal deterioration appears to increase with AUC, which doubled at a CrCl of 10 mL/minute.
Protein binding: 23% to 53%
Metabolism: Primarily eliminated intact via the kidney; metabolism not likely
Half-life elimination: Triphasic; Terminal: 146 hours
Excretion: Urine (39% ± 16% as unchanged drug) within 24 hours; feces (<3%)
Renal function impairment: Mild renal impairment (CrCl 50 to 80 mL/minute) increased AUC by an average of 15%. Moderate renal impairment (CrCl 30 to 50 mL/minute) increased AUC by an average of 43%. The risk of renal deterioration appears to increase with AUC, which doubled at a CrCl of 10 mL/minute.
禁忌症
1. Hypersensitivity to zoledronic acid or other bisphosphonates
2. hypocalcemia
3. CrCl <35 mL/minute and in those with evidence of acute renal impairment
4. pregnancy
5. breast-feeding
2. hypocalcemia
3. CrCl <35 mL/minute and in those with evidence of acute renal impairment
4. pregnancy
5. breast-feeding
懷孕分類
It is not known if bisphosphonates cross the placenta, but fetal exposure is expected
哺乳分類
副作用
Lower extremity edema, hypotension, Fatigue, pain, headache, dizziness, insomnia, depression, anxiety, agitation, confusion, hypoesthesia, rigors, Alopecia, dermatitis, Dehydration, hypophosphatemia, hypokalemia, hypomagnesemia, hypocalcemia, Nausea, vomiting, constipation, diarrhea, anorexia, weight loss, abdominal pain, decreased appetite, urinary tract infection,a nemia, progression of cancer, neutropenia, infusion-related reaction, candidiasis, Ostealgia, weakness, myalgia, arthralgia, back pain
劑量和給藥方法
1. Bone metastases, solid tumors : 4 mg once every 3 to 4 weeks.
2. Hypercalcemia of malignancy (albumin-corrected serum calcium 12 mg/dL) : 4 mg (maximum) given as a single dose. May repeat dose after 7 days if hypercalcemia persists.
1.Osteoporosis, prevention of fractures ( For males and postmenopausal females): Treatment: 5 mg once every 12 months. Prevention: 5 mg once every 2 years or 5 mg as a single dose. Duration of therapy: Consider discontinuing after 3 years if bone mineral density is stable. If fracture risk remains high, consider extending treatment for up to 6 years or switching to alternative therapy.
2. Glucocorticoid-induced (Avoid use in females who are pregnant, who plan on becoming pregnant, or who are not using effective birth control): 5 mg once every 12 months.
3. Paget disease (For symptomatic patients with active disease): Treatment: 5 mg as a single dose. Re-treatment: A repeat 5 mg dose may be considered after 12 months in patients with biochemical relapse (eg, increase in alkaline phosphatase), radiographic progression of disease, or recurrent pain.
小兒調整劑量
Note: Acetaminophen or ibuprofen 30 minutes prior to infusion and 6 hours after is recommended to reduce acute phase reactions
1. Children <2 years :
(1) First dose: 0.0125 mg/kg/dose.
(2) Maintenance (to begin 3 months after first dose): 0.025 mg/kg/dose every 3 months.
2. Children >2 years and Adolescents:
(1) First dose: 0.0125 mg/kg/dose.
(2) Second dose (3 months after first dose): 0.025 mg/kg/dose.
(3) Maintenance (to begin 6 months after first dose):0.05 mg/kg/dose every 6 months; maximum dose: 4 mg/dose.
3. Dose adjustment based on lumbar spine bone mineral density (BMD) Z score: Children >2 years and Adolescents:
(1) BMD Z score >or=2: Decrease dose to 0.025 mg/kg/dose every 6 months.
(2) BMD Z score >0: Decrease dose to 0.025 mg/kg/dose every 12 months.
腎功能調整劑量
CrCl 35 to 80 mL/minute: No dosage adjustment is necessary.
CrCl <35 mL/minute: Use is contraindicated.
Multiple myeloma and bone metastases from solid tumors:
CrCl >60 mL/minute: 4 mg (no dosage adjustment is necessary).
CrCl 50 to 60 mL/minute: Reduce dose to 3.5 mg.
CrCl 40 to 49 mL/minute: Reduce dose to 3.3 mg.
CrCl 30 to 39 mL/minute: Reduce dose to 3 mg.
CrCl <30 mL/minute: Use is not recommended.
肝功能調整劑量
安定性
藥袋資訊
臨床用途
腫瘤引起的高血鈣、腫瘤引起的骨轉移
主要副作用
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
急首 h2 | 藥庫 注G11
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
3101
自費價
3721.2
仿單
資料庫
健保給付規定