"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.
GCTB generally occurs in a"...
FOR INTRAVENOUS USE
Care must be taken to avoid extravasation during injection as the high pH of fluorescein solution can result in severe local tissue damage. The following complications resulting from extravasation of fluorescein have been noted to occur: Sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. Rare cases of death due to anaphylaxis have been reported (See PRECAUTIONS).
Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to FLUORESCITE® (fluorescein) Injection 10%. Use only if the container is undamaged.
If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.
Carcinogenesis, Mutagenesis, Impairment of Fertility
There have been no long-term studies done using fluorescein in animals to evaluate carcinogenic potential.
Teratogenic Effects: Pregnancy Category C
Adequate animal reproduction studies have not been conducted with fluorescein sodium. It is also not known whether fluorescein sodium can cause fetal harm when administered to a pregnant woman. Fluorescein sodium should be given to a pregnant woman only if clearly needed.
Fluorescein sodium has been demonstrated to be excreted in human milk. Caution should be exercised when fluorescein sodium is administered to a nursing woman.
Safety and effectiveness in pediatric patients have been established.
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Fluorescite 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.
Find out what women really need.