Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Adverse reactions to the arterial infusion of floxuridine are generally related to the procedural complications of regional arterial infusion.
The more common adverse reactions to the drug are nausea, vomiting, diarrhea, enteritis, stomatitis and localized erythema.
The more common laboratory abnormalities are anemia, leukopenia, thrombo-cytopenia and elevations of alkaline phosphatase, serum transaminase, serum bilirubin and lactic dehydrogenase.
Other adverse reactions are: Gastrointestinal: duodenal ulcer, duodenitis, gastritis, bleeding, gastroenteritis, glossitis, pharyngitis, anorexia, cramps, abdominal pain;
possible intra- and extrahepatic biliary sclerosis, as well as acalculous cholecystitis.
Dermatologic: alopecia, dermatitis, nonspecific skin toxicity, rash.
Cardiovascular: myocardial ischemia.
Miscellaneous Clinical Reactions: fever, lethargy, malaise, weakness.
Laboratory Abnormalities: BSP, prothrombin, total proteins, sedimentation rate and thrombopenia.
Procedural Complications of Regional Arterial Infusion: arterial aneurysm;
WARNINGS BECAUSE OF THE POSSIBILITY OF SEVERE TOXIC REACTIONS, ALL PATIENTS SHOULD BE HOSPITALIZED FOR THE FIRST COURSE OF THERAPY.
Floxuridine should be used with extreme caution in poor risk patients with impaired hepatic or renal function or a history of high-dose pelvic irradiation or previous use of alkylating agents.
The drug is not intended as an adjuvant to surgery.
Floxuridine may cause fetal harm when administered to a pregnant woman.
It has been shown to be teratogenic in the chick embryo, mouse (at doses of 2.5 to 100 mg/kg) and rat (at doses of 75 to 150 mg/kg).
Like all medications, Floxuridine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: