Nursing Mothers It is not known whether this drug is excreted in human milk. Warnings Hypersensitivity Reactions Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies such as fanolesomab. Emergency resuscitation personnel and equipment for the treatment of hypersensitivity reactions should be immediately available during administration of this agent. All remaining images should be collected for the same duration of time required for the anterior supine image. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been conducted to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
Murine monoclonal antibodies are frequently immunogenic. Two patients enrolled in studies of post surgical infection or abscess had serious adverse events associated with fatality hypotension and worsening of sepsis. Planar imaging should be performed using a large field of view camera fitted with a low-energy, parallel-hole, high-resolution collimator. Pregnancy Pregnancy Category C.
Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management. Immunogenicity data are highly dependent on the sensitivity and specificity of the assay.
The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Whenever possible, infant formula should be substituted for breast milk until the radioactivity has cleared from the body of the nursing woman.
Spilled urine should be cleaned up completely. The abnormal localization of radiotracer remains constant or increases in intensity in follow up imaging. No overall differences in safety or effectiveness were observed between these patients and patients in other age brackets, however, this number of patients is too few to exclude differences.
Overdosage There is no experience with overdosage in clinical trials. Whenever possible, a toilet should be used, rather than a urinal and the toilet should be flushed several times after each use.
The camera should be positioned so that the lower edge of the liver is at the upper end of the field of view at the midline of the patient. Recommended imaging times and procedures are the same as for adults.
If blood, urine or feces soil clothing, the clothing should be washed separately. Dose adjustment has not been established in patients with renal insufficiency, in geriatric patients or in pediatric patients under five years of age. Information for patients Murine monoclonal antibodies such as fanolesomab are foreign proteins and their administration can induce hypersensitivity reactions. To minimize the radiation-absorbed dose to the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after injection. Following administration, flush the injection line with an appropriate volume of saline to assure administration of the total dose.