Zoledronicdosage

Infusion given intravenously over no less than 15 minutes: Treatment of postmenopausal osteoporosis; treatment to increase bone mass in men with osteoporosis: treatment and prevention of glucocorticoid-induced osteoporosis: 5 mg once a year Prevention of postmenopausal osteoporosis: 5 mg once every 2 years Treatment of Paget's disease of bone: a single 5 mg infusion. Patients should receive 1500 mg elemental calcium and 800 international units vitamin D daily

2.1 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 Injection. 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 Injection administration may reduce the incidence of acute-phase reaction symptoms.

Caution: After removing the overwrap check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard container as sterility may be compromised. Use only if solution is clear and the container is undamaged.

Preparation for Administration: Close flow control clamp of administration set. Remove cover from port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.

NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Zoledronic Acid Injection. Open flow control clamp to expel air from set. Close clamp. Regulate rate of administration with flow control clamp.

2.2 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.

2.3 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.

2.4 Osteoporosis in

Men The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

2.5 Treatment and

Prevention of Glucocorticoid-Induced Osteoporosis The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes.

2.6 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 Injection in Paget's disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with Zoledronic Acid Injection 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.

2.7 Laboratory

Testing and Oral Examination Prior to Administration Prior to administration of each dose of Zoledronic Acid Injection, obtain a serum creatinine and creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each Zoledronic Acid Injection dose. Zoledronic Acid Injection 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 Injection administered intravenously is recommended for patients with creatinine clearance greater than or equal to 35 mL/min. There are no safety or efficacy data to support the adjustment of the Zoledronic Acid Injection dose based on baseline renal function. Therefore, no dose adjustment is required in patients with CrCl greater than or equal to 35 mL/min. A routine oral examination should be performed by the prescriber prior to initiation of Zoledronic Acid Injection treatment.

2.8 Calcium and

Vitamin D Supplementation Instruct patients being treated for Paget's disease of bone on the importance of calcium and vitamin D supplementation in 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 Injection 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 to 1000 international units vitamin D daily is recommended.

2.9 Method of

Administration The Zoledronic Acid Injection infusion time must not be less than 15 minutes given over a constant infusion rate. The intravenous infusion should be followed by a 10 mL normal saline flush of the intravenous line. Zoledronic Acid Injection 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 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 to 8°C (36°F to 46°F).