Label: XGEVA- denosumab injection

  • NDC Code(s): 55513-730-01, 55513-730-21
  • Packager: Amgen, Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated April 11, 2025

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use XGEVA® safely and effectively. See full prescribing information for XGEVA. Xgeva (denosumab) injection, for subcutaneous ...
  • Table of Contents
    Table of Contents
  • 1       INDICATIONS AND USAGE
    1.1       Multiple Myeloma and Bone Metastasis from Solid Tumors - Xgeva is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone ...
  • 2       DOSAGE AND ADMINISTRATION
    2.1       Important Administration Instructions - Xgeva is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally. 2.2 ...
  • 3       DOSAGE FORMS AND STRENGTHS
    Injection: 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.
  • 4       CONTRAINDICATIONS
    4.1       Hypocalcemia - Pre-existing hypocalcemia must be corrected prior to initiating therapy with Xgeva [see Warnings and Precautions (5.3)]. 4.2       Hypersensitivity - Xgeva is ...
  • 5       WARNINGS AND PRECAUTIONS
    5.1       Drug Products with Same Active Ingredient - Xgeva includes the same active ingredient (denosumab) found in Prolia. Patients receiving Xgeva should not take Prolia. 5.2 ...
  • 6       ADVERSE REACTIONS
    The following adverse reactions are discussed below and elsewhere in the labeling:         • Hypersensitivity [see Warnings and Precautions (5.2)]         • Hypocalcemia [see Warnings and ...
  • 8       USE IN SPECIFIC POPULATIONS
    8.1       Pregnancy - Risk Summary - Based on findings in animals and its mechanism of action, Xgeva can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ...
  • 10       OVERDOSAGE
    There is no experience with overdosage of Xgeva.
  • 11       DESCRIPTION
    Xgeva (denosumab) is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian ...
  • 12       CLINICAL PHARMACOLOGY
    12.1       Mechanism of Action - Xgeva binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone ...
  • 13       NONCLINICAL TOXICOLOGY
    13.1       Carcinogenesis, Mutagenesis, Impairment of Fertility - The carcinogenic potential of denosumab has not been evaluated in long-term animal studies.  The genotoxic potential of ...
  • 14       CLINICAL TRIALS
    14.1       Bone Metastasis from Solid Tumors - The safety and efficacy of Xgeva for the prevention of skeletal-related events in patients with bone metastases from solid tumors was ...
  • 16       HOW SUPPLIED/STORAGE AND HANDLING
    Xgeva is supplied in a single-dose vial. 120 mg/1.7 mL 1 vial per cartonNDC 55513-730-01 - NDC 55513-730-21 - Store Xgeva in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original ...
  • 17       PATIENT COUNSELING INFORMATION
    Drug Products with Same Active Ingredient - Advise patients that denosumab is also marketed as Prolia, and if taking Xgeva, they should not receive Prolia [see Warnings and Precautions ...
  • PRINCIPAL DISPLAY PANEL - 1.7 mL Vial Carton - 55513-730-01
    AMGEN - 120 - mg/1.7mL - XGEVA® (denosumab) 120 mg/1.7 mL - (70 mg/mL) Injection - For Subcutaneous Use Only - Single-Dose Vial. Discard Unused Portion.
  • PRINCIPAL DISPLAY PANEL - 1.7 mL Vial Carton - 55513-730-21
    AMGEN® 120 - mg/1.7mL - XGEVA® (denosumab) 120 mg/1.7 mL - (70 mg/mL) Injection - For Subcutaneous Use Only - Single-Dose Vial. Discard Unused Portion.
  • INGREDIENTS AND APPEARANCE
    Product Information