"The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
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Use only if the container is undamaged.
Carcinogenesis: Studies in animals to evaluate the carcinogenic potential have not been conducted.
Pregnancy: Category C. There are no adequate and well-controlled studies in pregnant women. MIOSTAT® (carbachol intraocular solution, USP) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing mothers: It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman.
Pediatric Use: Safety and efficacy in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.
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