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Bone Metastasis From Solid Tumors
Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
Limitation of Use
Giant Cell Tumor Of Bone
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.
DOSAGE AND ADMINISTRATION
Bone Metastasis from Solid Tumors
The recommended dose of Xgeva is 120 mg administered as a subcutaneous injection every 4 weeks in the upper arm, upper thigh, or abdomen.
Giant Cell Tumor of Bone
The 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].
Preparation And Administration
Visually 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].
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.
Dosage Forms And Strengths
120 mg/1.7 mL (70 mg/mL) single-use vial.
Storage And Handling
Xgeva is supplied in a single-use vial.
|120 mg/1.7 mL||1 vial per carton||NDC 55513-730-01|
Store Xgeva in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton. Do not freeze. Once removed from the refrigerator, Xgeva must not be exposed to temperatures above 25°C/77°F or direct light and must be used within 14 days. Discard Xgeva if not used within the 14 days. Do not use Xgeva after the expiry date printed on the label.
Protect Xgeva from direct light and heat.
Avoid vigorous shaking of Xgeva.
Manufactured by: Amgen Manufacturing Limited, a subsidiary of Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799. Revised: June 2014
Last reviewed on RxList: 6/16/2014
This monograph has been modified to include the generic and brand name in many instances.
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