Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Información selecta para pacientes y cuidadores que se encuentra disponible en Español.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

zoledronic acid for injection 4 MG BAG Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Hypercalcemia of Malignancy

1.2 Multiple Myeloma and Bone Metastases of Solid Tumors

2 DOSAGE AND ADMINISTRATION

2.1 Hypercalcemia of Malignancy

2.2 Multiple Myeloma and Bone Metastases of Solid Tumors

2.3 Preparation of Solution

2.4 Method of Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Drugs with Same Active Ingredient or in the Same Drug Class

5.2 Hydration and Electrolyte Monitoring

5.3 Renal Impairment

5.4 Osteonecrosis of the Jaw

5.5 Musculoskeletal Pain

5.6 Atypical Subtrochanteric and Diaphyseal Femoral Fractures

5.7 Patients with Asthma

5.8 Hepatic Impairment

5.9 Hypocalcemia

5.10 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Aminoglycosides and Calcitonin

7.2 Loop Diuretics

7.3 Nephrotoxic Drugs

7.4 Thalidomide

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Hypercalcemia of Malignancy

14.2 Clinical Trials in Multiple Myeloma and Bone Metastases of Solid Tumors

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event