Xgeva
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
Limitation of Use:
Xgeva is not indicated for the prevention of skeletal-related events in patients with multiple myeloma [see Clinical Trials (14.1)].
Xgeva is indicated for the 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.
Xgeva is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy [see Clinical Trials (14.3)].
History
There is currently no drug history available for this drug.
Other Information
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 (Chinese hamster ovary) cells.
Xgeva is a sterile, preservative-free, clear, colorless to pale yellow solution.
Each single-use vial of Xgeva contains 120 mg denosumab, acetate (18 mM), sorbitol (4.6%), Water for Injection (USP), and sodium hydroxide to a pH of 5.2.
Sources
Xgeva Manufacturers
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Amgen Inc
![Xgeva (Denosumab) Injection [Amgen Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Xgeva | Amgen Inc
2.1 Important Administration InstructionsXgeva is intended for subcutaneous route only and should not be administered intravenously, intramuscularly, or intradermally.
2.2 Bone Metastasis from Solid TumorsThe recommended dose of Xgeva is 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen.
Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia [see Warnings and Precautions (5.3)].
2.3 Giant Cell Tumor of BoneThe recommended dose of Xgeva is 120 mg administered 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.
Administer calcium and vitamin D as necessary to treat or prevent hypocalcemia [see Warnings and Precautions (5.3)].
2.4 Hypercalcemia of MalignancyThe recommended dose of Xgeva is 120 mg administered 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.
2.5 Preparation and AdministrationVisually inspect Xgeva for particulate matter and discoloration prior to administration. Xgeva is a clear, colorless to pale yellow solution that may contain trace amounts of translucent to white proteinaceous particles. Do not use if the solution is discolored or cloudy or if the solution contains many particles or foreign particulate matter.
Prior to administration, Xgeva may be removed from the refrigerator and brought to room temperature (up to 25°C/77°F) by standing in the original container. This generally takes 15 to 30 minutes. Do not warm Xgeva in any other way [see How Supplied/Storage and Handling (16)].
Use a 27-gauge needle to withdraw and inject the entire contents of the vial. Do not re-enter the vial. Discard vial after single-use or entry.
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