Postmenopausal osteoporosis, Paget’s disease of bone
藥理
Aclasta is a bisphosphonate and acts primarily on bone. It is an inhibitor of osteoclast-mediated bone resorption.
藥動學
Plasma concentrations of zoledronate rise rapidly after the start of an IV infusion. Plasma protein binding is low (28-56%). Zoledronate is not metabolised, and about 23 to 55% of the dose is excreted in the urine unchanged within 24 hours; the remainder is mainly sequestered to bone and only very slowly eliminated. Terminal elimination half-life is about 146 hours. Renal clearance is slower in patients with severe renal impairment
禁忌症
Hypocalcaemia, Hypersensitivity to zoledronic acid or any components of Aclasta.
懷孕分類
D
哺乳分類
Avoided
副作用
Major adverse effects are post-dosage symptoms including influenza-like illness, pyrexia, arthralgia, myalgia, headache and often happened within 3 days after infusion.
劑量和給藥方法
5 mg IV infused over no less than 15 min every 12 months; Do not infuse if calcium is below normal or estimated Clcr is < 35ml/min. Patient should be advised to take at least 1000 mg calcium and 400-800 IU vitamin D daily, especially during the initial 10 days after infusion.
小兒調整劑量
腎功能調整劑量
肝功能調整劑量
安定性
Once opened, solutions may be stored up to 24 hours between 2 and 8 ℃
注意事項:
1. Aclasta注射液不得接觸到任何含有鈣離子或其他二價離子的溶液,須以單獨的輸注管以單次注射給藥。輸注時間至少15分鐘以上。
2. 建議預防性給藥以減緩注射後的不適如發燒、頭痛、關節痛、肌肉痛等。
3. 建議每日至少補充1000 mg calcium 及 400-800 IU vitamin D及足夠的水份。