"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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Nephrogenic Systemic Fibrosis
Instruct patients to inform their healthcare provider if they:
- have a history of kidney disease, or
- have recently received a GBCA.
GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. To counsel patients at risk for NSF:
- Describe the clinical manifestations of NSF.
- Describe procedures to screen for the detection of renal impairment.
Instruct the patients to contact their physician if they develop signs or symptoms of NSF following DOTAREM administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.
Common Adverse Reactions
Inform patients that they may experience:
- Reactions along the venous injection site, such as mild and transient burning or pain or feeling of warmth or coldness at the injection site.
- Side effects of headache, nausea, abnormal taste and feeling hot.
Instruct patients receiving DOTAREM to inform their physician if they:
- Are pregnant or breastfeeding.
- Have a history of allergic reaction to contrast media, bronchial asthma or allergy.
- Are taking any medications.
Last reviewed on RxList: 4/5/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Dotarem Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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