Nephrotoxic drugs: Use with caution (7.3)

 
USE IN SPECIFIC POPULATIONS
Nursing Mothers: It is not known whether Zometa is excreted in human milk (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: 06/2011
 

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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

1 INDICATIONS AND USAGE
1.1 Hypercalcemia of Malignancy
1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
1.3 Important Limitation of Use
2DOSAGE AND ADMINISTRATION
2.1 Hypercalcemia of Malignancy
2.2 Multiple Myeloma and Metastatic Bone Lesions of Solid Tumors
2.3 Preparation of Solution
2.4 Method of Administration
3 DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
4.1 Hypersensitivity to ZoledronicAcid or Any Components of Zometa
5 WARNINGS AND PRECAUTIONS
5.1 Drugs with Same Active Ingredient or in the Same Drug Class5.2 Hydration and Electrolyte Monitoring
5.3 Renal Impairment
5.4 Osteonecrosis of the Jaw
5.5 Musculoskeletal Pain
5.6 Patients with Asthma
5.7 Hepatic Impairment
5.8 Use in Pregnancy
6ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
7DRUG INTERACTIONS
7.1 Aminoglycosides
7.2 Loop Diuretics
7.3 Nephrotoxic Drugs
7.4 Thalidomide
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10OVERDOSAGE
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14CLINICAL STUDIES
14.1 Hypercalcemia of Malignancy
14.2 Clinical Trials in Multiple Myeloma and Bone Metastases of Solid Tumors
16HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
 

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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Hypercalcemia of Malignancy
Zometa is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12mg/dL [3.0mmol/L] using the formula: cCa in mg/dL=Ca in mg/dL+0.8 (4.0 g/dL - patient albumin (g/dL)).

1.2 Multiple Myeloma and Bone Metastases of Solid Tumors
Zometa 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.

1.3 Important Limitation of Use
The safety and efficacy of Zometa in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions has not been established.

2DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whene