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ZOLEDRONIC ACID INJECTION - PREMIXED SOLUTION FOR INTRAVENOUS INFUSION (FOR SINGLE DOSE) (zoledronic acid for injection - PREMIXED SOLUTION FOR INTRAVENOUS INFUSION (FOR SINGLE DOSE)) 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 use
Initial U.S. Approval: 2001

RECENT MAJOR CHANGES

Warnings and Precautions, Embryo-Fetal Toxicity (5.10)11/2018

INDICATIONS AND USAGE

Zoledronic acid is a bisphosphonate indicated for the treatment of:

  • Hypercalcemia of malignancy. (1.1)
  • Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2)

Limitations of use: The safety and efficacy of zoledronic acid has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.

DOSAGE AND ADMINISTRATION

Hypercalcemia of malignancy (2.1)

  • 4 mg as a single­dose intravenous infusion over no less than 15 minutes.
  • 4 mg as retreatment after a minimum of 7 days.

Multiple myeloma and bone metastasis from solid tumors (2.2)

  • 4 mg as a single-dose intravenous infusion over no less than 15 minutes every 3 – 4 weeks for patients with creatinine clearance of greater than 60 mL/min.
  • Reduce the dose for patients with renal impairment.
  • Coadminister oral calcium supplements of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily.

Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation-containing solutions. (2.3)

DOSAGE FORMS AND STRENGTHS

4 mg/100 mL (0.04 mg/mL) single-dose premixed bag. (3)

CONTRAINDICATIONS

  • Hypersensitivity to any component of Zoledronic Acid Injection (4)

WARNINGS AND PRECAUTIONS

  • Patients being treated with Zoledronic Acid Injection should not be treated with Reclast®. (5.1)
  • Adequately rehydrate patients with hypercalcemia of malignancy prior to administration of Zoledronic Acid Injection and monitor electrolytes during treatment. (5.2)
  • Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4 mg. Treatment in patients with severe renal impairment is not recommended. Monitor serum creatinine before each dose. (5.3)
  • Osteonecrosis of the jaw has been reported. Preventive dental exams should be performed before starting Zoledronic Acid Injection. Avoid invasive dental procedures. (5.4)
  • Severe incapacitating bone, joint, and/or muscle pain may occur. Discontinue Zoledronic Acid Injection if severe symptoms occur. (5.5)
  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy. These fractures may occur after minimal or no trauma. Evaluate patients with thigh or groin pain to rule out a femoral fracture. Consider drug discontinuation in patients suspected to have an atypical femur fracture. (5.6)
  • Hypocalcemia: Correct before initiating Zoledronic Acid Injection. Adequately supplement patients with calcium and vitamin D. Monitor serum calcium closely with concomitant administration of other drugs known to cause hypocalcemia to avoid severe or life-threatening hypocalcemia. (5.9)
  • Zoledronic Acid Injection can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (5.10, 8.1, 8.3)

ADVERSE REACTIONS

The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea. (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 have an additive effect to lower serum calcium for prolonged periods. (7.1)
  • Loop diuretics: Concomitant use with zoledronic acid may increase risk of hypocalcemia. (7.2)
  • Nephrotoxic drugs: Use with caution. (7.3)

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise not to breastfeed. (8.2)
  • Females and Males of Reproductive Potential: Verify pregnancy status prior to initiation of Zoledronic Acid Injection. May impair fertility. (8.3)
  • 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.

Revised: 11/2018

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