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Xgeva ( denosumab ) i njection , for subcutaneous
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use X GEVA ® safely and effectively. See full prescribing information for X GEVA .
Xgeva ( denosumab ) i njection , for subcutaneous u se
Initial U.S. Approval: 2010
RECENT MAJOR CHANGES
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• Indications and Usage, Hypercalcemia of Malignancy (1.3) |
12/2014 |
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• Dosage and Administration, Important Administration |
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Instructions (2.1) |
12/2014 |
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• Dosage and Administration, Hypercalcemia of |
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Malignancy (2.4) |
12/2014 |
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• Warnings and Precautions, Hypocalcemia (5.3) |
06/2015 |
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• Warnings and Precautions, Osteonecrosis of the |
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Jaw (ONJ) (5.4) |
06/2015 |
INDICATIONS AND USAGE
Xgeva is a RANK ligand (RANKL) inhibitor indicated for:
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Prevention of skeletal-related events in patients with bone metastases from solid tumors (1.1)
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Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity (1.2, 14.2)
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Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy (1.3)
Limitation of use: Xgeva is not indicated for the prevention of skeletal-related events in patients with multiple myeloma
DOSAGE AND ADMINISTRATION
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Xgeva is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally (2.1)
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Bone Metastasis from Solid Tumors: Administer 120 mg every 4 weeks as a subcutaneous injection in the upper arm, upper thigh, or abdomen (2.2)
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Giant Cell Tumor of Bone: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen (2.3)
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Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia (2.2, 2.3)
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Hypercalcemia of Malignancy: Administer 120 mg every 4 weeks with additional 120 mg doses on Days 8 and 15 of the first month of therapy. Administer subcutaneously in the upper arm, upper thigh, or abdomen (2.4)
DOSAGE FORMS AND STRENGTHS
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Injection: 120 mg/1.7 mL (70 mg/mL) solution in a single-use vial (3)
CONTRAINDICATIONS
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Hypocalcemia (4.1)
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Known clinically significant hypersensitivity to Xgeva (4.2)
WARNINGS AND PRECAUTIONS
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Same Active Ingredient: Patients receiving Xgeva should not take Prolia® (5.1)
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Hypersensitivity reactions including anaphylaxis may occur. Discontinue permanently if a clinically significant reaction occurs (5.2)
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Hypocalcemia: Xgeva can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct hypocalcemia prior to initiating Xgeva. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D (5.3)
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Osteonecrosis of the jaw (ONJ) has been reported in patients receiving Xgeva. Perform an oral examination prior to starting Xgeva. Monitor for symptoms. Avoid invasive dental procedures during treatment with Xgeva (5.4)
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Atypical femoral fracture: eva luate patients with thigh or groin pain to rule out a femoral fracture (5.5)
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Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use highly effective contraception (5.6, 8.1, 8.7)
ADVERSE REACTIONS
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Bone Metastasis from Solid Tumors: Most common adverse reactions (per-patient incidence greater than or equal to 25%) were fatigue/asthenia, hypophosphatemia, and nausea (6.1)
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Giant Cell Tumor of Bone: Most common adverse reactions (per-patient incidence greater than or equal to 10%) were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity (6.1)
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Hypercalcemia of Malignancy: Adverse reactions in greater than 20% of patients were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
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Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother (8.3)
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Pediatric patients: Recommended only for treatment of skeletally mature adolescents with giant cell tumor of bone (8.4)
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Renal impairment: Patients with creatinine clearance less than 30 mL/min or receiving dialysis are at risk for hypocalcemia. Adequately supplement with calcium and vitamin D (8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 6/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
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