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ZOLEDRONIC ACID INJECTION - FOR INTRAVENOUS INFUSION (zoledronic acid for injection - FOR INTRAVENOUS INFUSION) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ZOLEDRONIC ACID INJECTION safely and effectively. See full prescribing information for ZOLEDRONIC ACID INJECTION.
ZOLEDRONIC ACID INJECTION, for intravenous infusion
Initial U.S. Approval: 2001

INDICATIONS AND USAGE

Zoledronic acid is a bisphosphonate indicated for:

Treatment of Paget's disease of bone in men and women (1.5)

DOSAGE AND ADMINISTRATION

Infusion given intravenously over no less than 15 minutes:

Treatment of Paget's disease of bone: a single 5 mg infusion. Patients should receive 1,500 mg elemental calcium and 800 international units vitamin D daily (2.6)

DOSAGE FORMS AND STRENGTHS

5 mg in a 100 mL ready-to-infuse solution (3)

CONTRAINDICATIONS

Hypocalcemia (4)
Patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment (4, 5.3)
Hypersensitivity to any component of Zoledronic Acid Injection (4, 6.2)

WARNINGS AND PRECAUTIONS

Products Containing Same Active Ingredient: Patients receiving Zometa should not receive Zoledronic Acid Injection (5.1)
Hypocalcemia may worsen during treatment. Patients must be adequately supplemented with calcium and vitamin D (5.2)
Renal Impairment: A single dose should not exceed 5 mg and the duration of infusion should be no less than 15 minutes. Renal toxicity may be greater in patients with underlying renal impairment or with other risk factors, including advanced age or dehydration. Monitor creatinine clearance before each dose (2.7, 5.3)
Osteonecrosis of the Jaw (ONJ) has been reported. All patients should have a routine oral exam by the prescriber prior to treatment (5.4)
Atypical Femur Fractures have been reported. Patients with thigh or groin pain should be evaluated to rule out a femoral fracture (5.5)
Severe Bone, Joint, and Muscle Pain may occur. Withhold future doses of zoledronic acid if severe symptoms occur (5.7)

ADVERSE REACTIONS

The most common adverse reactions (greater than 10%) were pyrexia, myalgia, headache, arthralgia, pain in extremity (6.1). Other important adverse reactions were flu-like illness, nausea, vomiting, diarrhea (6.2), and eye inflammation (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Aminoglycosides: May lower serum calcium for prolonged periods (7.1)
Loop diuretics: May increase risk of hypocalcemia (7.2)
Nephrotoxic drugs: Use with caution (7.3)
Drugs primarily excreted by the kidney: Exposure may be increased with renal impairment. Monitor serum creatinine in patients at risk (7.4)

USE IN SPECIFIC POPULATIONS

Pregnancy: Discontinue when pregnancy is recognized (8.1)
Pediatric Use: Not indicated for use in pediatric patients (8.4)
Geriatric Use: Special care to monitor renal function (8.5)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 7/2020

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