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:

JHP Pharmaceuticals, LLC.

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. The safety and efficacy of Zoledronic Acid Injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established. Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see Adverse Reactions (6.2) ]. Pregnancy Category D [see Warnings and Precautions (5.9)] There are no adequate a

Product summary:

4 mg/5 mL single-use vial of concentrate Zoledronic Acid Injection, 4 mg/5 mL Carton of 1 vial (USP Type 1 Plus® glass)………………………..….NDC 42023-167-01 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE
JHP PHARMACEUTICALS, LLC.
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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
CONCENTRATE FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions, addition of atypical subtrochanteric and
diaphyseal femoral fractures (5.6) 03/2012
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)
Important limitation of use: The safety and efficacy of Zoledronic
Acid Injection has not been established for use in
hyperparathyroidism or nontumor-related hypercalcemia
(1.3)
DOSAGE AND ADMINISTRATION
Hypercalcemia of malignancy (2.1)
4 mg as a single-use 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-use 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 IU 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-use 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