Drug Description
Solution for infusion
Presentation
Each bottle with 100 ml of solution contains 5 mg zoledronic acid anhydrous, corresponding to 5.330 mg zoledronic acid monohydrate.One ml solution contains 0.05 mg zoledronic acid anhydrous, corresponding to 0.0533 mg zoledronic acid monohydrate.
Indications
'Aclasta' is indicated for the treatment of osteoporosis in post-menopausal women andosteoporosis treatmentin men both at increased risk of fracture, including those with a recent low-trauma hip fracture.
Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture.
Treatment of Paget's disease of the bone.
Adult Dosage
For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year.
In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair.
For the treatment of Paget's disease, Aclasta should be prescribed only by physicians with experience in treatment of Paget's disease of the bone. The recommended dose is a single intravenous infusion of 5 mg Aclasta. Retreatment of Paget's disease: specific retreatment data are not available. After a single treatment with Aclasta in Paget's disease, an extended remission period is observed in responding patients.
Aclasta (5 mg in 100 ml ready-to-infuse solution) is administered via a vented infusion line and given at a constant infusion rate. The infusion time must not be less than 15 minutes. For information on the infusion of Aclasta.
Patients must be appropriately hydrated prior to administration of Aclasta. This is especially important for the elderly and for patients receiving diuretic therapy.
Adequate calcium and vitamin D intake are recommended in association with Aclasta administration. In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Aclasta administration.
In patients with a recent low-trauma hip fracture, a loading dose of 50,000 to 125,000 IU of vitamin D given orally or via the intramuscular route is recommended prior to the first Aclasta infusion.
The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.
Patients with renal impairment
