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ZOLEDRONIC ACID INJECTION - FOR INTRAVENOUS INFUSION (zoledronic acid for injection - FOR INTRAVENOUS INFUSION) Dosage and Administration

2 DOSAGE AND ADMINISTRATION

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 [see Warnings and Precautions (5.3)].
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.

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 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.

2.7 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 or equal to 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 or equal to 35 mL/min [see Contraindications (4), Warnings and Precautions (5.3)].
A routine oral examination should be performed by the prescriber prior to initiation of zoledronic acid treatment [see Warnings and Precautions (5.4)].

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 1,500 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 [see Warnings and Precautions (5.2)].

2.9 Method of Administration

The zoledronic acid infusion time must not be less than 15 minutes 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.

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