Floxuridine 100 mg/mL
Floxuridine · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Hikma Pharmaceuticals USA Inc.
Floxuridine is a injection, powder, lyophilized, for solution containing floxuridine at 100 mg/mL, taken intra-arterial. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Floxuridine
- Generic Name
- Floxuridine
- NDC Code (Product)
0143-9270- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRA-ARTERIAL
- Marketing Status
- Application #
- ANDA075387
- Drug Class
- Antimetabolite [EPC]
- Marketing Start
- 02/15/2018
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Floxuridine for Injection, USP is effective in the palliative management of gastrointestinal adenocarcinoma metastatic to the liver, when given by continuous regional intra-arterial infusion in carefully selected patients who are considered incurable by surgery or other means. Patients with known disease extending beyond an area capable of infusion via a single artery should, except in unusual circumstances, be considered for systemic therapy with other chemotherapeutic agents.
Dosage & Administration
DOSAGE AND ADMINISTRATION Each vial must be reconstituted with 5 mL of sterile water for injection to yield a solution containing approximately 100 mg of floxuridine/mL. The calculated daily dose(s) of the drug is then diluted with 5% dextrose or 0.9% sodium chloride injection to a volume appropriate for the infusion apparatus to be used. The administration of floxuridine is best achieved with the use of an appropriate pump to overcome pressure in large arteries and to ensure a uniform rate of infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The recommended therapeutic dosage schedule of floxuridine by continuous arterial infusion is 0.1 to 0.6 mg/kg/day. The higher dosage ranges (0.4 to 0.6 mg) are usually employed for hepatic artery infusion because the liver metabolizes the drug, thus reducing the potential for systemic toxicity. Therapy can be given until adverse reactions appear. (See PRECAUTIONS section.) When these side effects have subsided, therapy may be resumed. The patient should be maintained on therapy as long as response to floxuridine continues. Pr…
Warnings
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). Malformations included cleft palates; skeletal defects; and deformed appendages, paws and tails. The dosages which were teratogenic in animals are 4.2 to 125 times the recommended human therapeutic dose. There are no adequate and well-controlled studies with floxuridine in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Combination Therapy Any form of therapy which adds to the stress of the …
Contraindications
CONTRAINDICATIONS Floxuridine therapy is contraindicated for patients in a poor nutritional state, those with depressed bone marrow function or those with potentially serious infections.
Drug Interactions
Drug Interactions See WARNINGS section.
Adverse Reactions
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; arterial ischemia; arterial thrombosis; embolism; fibromyositis; thrombophlebitis; hepatic necrosis; abscesses; infection …
Frequently Asked Questions
What is Floxuridine used for?
Floxuridine contains Floxuridine. It is a injection, powder, lyophilized, for solution taken intra-arterial. Consult your doctor for specific uses.
Is Floxuridine a controlled substance?
Floxuridine is not classified as a controlled substance by the DEA.
What is the generic name for Floxuridine?
The generic name for Floxuridine is Floxuridine. There are no other listed brand versions of Floxuridine.
What is the NDC code for Floxuridine 100 mg/mL?
The NDC (National Drug Code) for Floxuridine 100 mg/mL is 0143-9270, listed by Hikma Pharmaceuticals USA Inc..
Other Floxuridine Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)