ZOLEDRONIC ACID- zoledronic acid injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)

Available from:

Actavis Pharma, Inc.

INN (International Name):

ZOLEDRONIC ACID

Composition:

ZOLEDRONIC ACID ANHYDROUS 4 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zoledronic Acid Injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3.0 mmol/L] using the formula: cCa in mg/dL=Ca in mg/dL + 0.8 (4.0 g/dL - patient albumin [g/dL]). Zoledronic Acid Injection is indicated for the treatment of 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. Limitations of Use The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. Hypersensitivity to Zoledronic Acid or Any Components of Zoledronic Acid Injection Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see Ad

Product summary:

Each 5 mL vial contains 4.264 mg zoledronic acid monohydrate, corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and 24 mg of sodium citrate, USP. Carton of 1 vial ............................................................................................NDC 45963-440-55 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE
ACTAVIS PHARMA, INC.
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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
INDICATIONS AND USAGE
Zoledronic Acid Injection 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
Injection 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 single-dose 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 to 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/5 mL single-dose vial of concentrate (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 A