ZOLEDRONIC ACID- zoledronic acid injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Heritage Pharmaceuticals Inc.

INN (International Name):

ZOLEDRONIC ACID

Composition:

ZOLEDRONIC ACID ANHYDROUS 5 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zoledronic acid injection is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see Clinical Studies (14.5) ]. Zoledronic acid injection is contraindicated in patients with the following conditions: - Hypocalcemia [see Warnings and Precautions (5.2) ] - Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions (5.3) ]. - Known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. Hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Post-Marketing Experience (6.2) ]. Pregnancy Category D [see Warnings and Precautio

Product summary:

Each bottle contains a clear, colorless solution of Zoledronic Acid Injection 5 mg/100 mL and is packed individually in a carton. NDC 23155-525-31. Handling After opening the solution, it is stable for 24 hours at 2°C to 8°C (36°F to 46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
HERITAGE PHARMACEUTICALS 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
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 01/2015
INDICATIONS AND USAGE
Zoledronic acid injection 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 1500 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).
_Pregnancy:_ Zoledronic acid injection can cause fetal harm. Women of
c