Zoruxa Dosage/Direction for Use

Important Administration Instructions: Zoledronic acid injection must be administered as an intravenous infusion over no less than 15 minutes.
Patients must be appropriately hydrated prior to administration of Zoledronic acid.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Intravenous infusion should be followed by a 10 ml normal saline flush of the intravenous line.
Administration of acetaminophen following Zoledronic acid administration may reduce the incidence of acute-phase reaction symptoms.
Treatment of Osteoporosis in Postmenopausal Women: The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.
Prevention of Osteoporosis in Postmenopausal Women: The recommended regimen is a 5 mg infusion given once every 2 years intravenously over no less than 15 minutes.
Osteoporosis in Men: The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.
Treatment and Prevention of Glucocorticoid-lnduced Osteoporosis: The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.
Treatment of Paget's Disease of Bone: The recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate.
Re-treatment of Paget's Disease: After a single treatment with Zoledronic acid in Paget's disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with Zoledronic acid may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.
Laboratory Testing and Oral Examination Prior to Administration: Prior to administration of each dose of Zoledronic acid, obtain a serum creatinine and creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each Zoledronic acid dose. Zoledronic acid is contraindicated in patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment. A 5 mg dose of Zoledronic acid administered intravenously is recommended for patients with creatinine clearance greater than 35 mL/min. There are no safety or efficacy data to support the adjustment of the Zoledronic acid dose based on baseline renal function. Therefore, no dose adjustment is required in patients with CrCl greater than 35 mL/min.
A routine oral examination should be performed by the prescriber prior to initiation of Zoledronic acid treatment.
Calcium and Vitamin D Supplementation: Instruct patients being treated for Paget's disease of bone on the importance of calcium and vitamin D supplementationin maintaining serum calcium levels, and on the symptoms of hypocalcemia. All patients should take 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or 500 mg three times a day) and 800 international units vitamin D daily, particularly in the 2 weeks following Zoledronic acid administration.
Instruct patients being treated for osteoporosis to take supplemental calcium and vitamin D if their dietary intake is inadequate. An average of at least 1200 mg calcium and 800-1000 international units vitamin D daily is recommended.
Administration: The Zoledronic acid infusion time must not be less than 15minutes given over a constant infusion rate. The i.v. infusion should be followed by a 10 ml normal saline flush of the intravenous line.
Zoledronic acid solution for infusion must not be allowed to come in contact with any calcium or other divalent cation-containing solutions, and should be administered as a single intravenous solution through a separate vented infusion line.
If refrigerated, allow the refrigerated solution to reach room temperature before administration. After opening, the solution is stable for 24 hours at 2°C-8°C (36°F-46°F).