Floxuridine (Page 2 of 2)

Pregnancy

Teratogenic Effects: Pregnancy category D.

See WARNINGS. Floxuridine 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 3.2 to 125 times the recommended human therapeutic dose.

There are no adequate and well-controlled studies with floxuridine in pregnant women. While there is no evidence of teratogenicity in humans due to floxuridine, it should be kept in mind that other drugs which inhibit DNA synthesis (eg, methotrexate and aminopterin) have been reported to be teratogenic in humans. Floxuridine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Floxuridine has not been studied in animals for its effects on peri- and postnatal development. However, compounds which inhibit DNA, RNA and protein synthesis might be expected to have adverse effects on peri- and postnatal development.

Nursing Mothers

It is not known whether floxuridine is excreted in human milk. Because floxuridine inhibits DNA and RNA synthesis, mothers should not nurse while receiving this drug.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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, thrombocytopenia 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 at catheter site; bleeding at catheter site; catheter blocked, displaced or leaking.

The following adverse reactions have not been reported with floxuridine but have been noted following the administration of 5-fluorouracil. While the possibility of these occurring following floxuridine therapy is remote because of its regional administration, one should be alert for these reactions following the administration of floxuridine because of the pharmacological similarity of these two drugs: pancytopenia, agranulocytosis, myocardial ischemia, angina, anaphylaxis, generalized allergic reactions, acute cerebellar syndrome, nystagmus, headache, dry skin, fissuring, photosensitivity, pruritic maculopapular rash, increased pigmentation of the skin, vein pigmentation, lacrimal duct stenosis, visual changes, lacrimation, photophobia, disorientation, confusion, euphoria, epistaxis and nail changes, including loss of nails.

OVERDOSAGE:

The possibility of overdosage with floxuridine is unlikely in view of the mode of administration. Nevertheless, the anticipated manifestations would be nausea, vomiting, diarrhea, gastrointestinal ulceration and bleeding, bone marrow depression (including thrombocytopenia, leukopenia and agranulocytosis). No specific antidotal therapy exists. Patients who have been exposed to an overdosage of floxuridine should be monitored hematologically for at least 4 weeks. Should abnormalities appear, appropriate therapy should be utilized. The acute intravenous toxicity of floxuridine is as follows:

Species LD 50 (mg/kg ± S.E.)
Mouse 880 ± 51
Rat 670 ± 73
Rabbit 94 ± 19.6
Dog 157 ± 46

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). When these side effects have subsided, therapy may be resumed. The patients should be maintained on therapy as long as response to floxuridine continues.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

HOW SUPPLIED:

Product No. NDC No.
104507 63323-145-07 Floxuridine for Injection, USP, 500 mg floxuridine powder in a 5 mL vial, packaged individually. This is to be reconstituted with 5 mL sterile water for injection.

The container closure is not made with natural rubber latex.

The sterile powder should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Reconstituted vials should be stored under refrigeration 2° to 8°C (36° to 46°F) for not more than 2 weeks.

REFERENCES:

  1. Recommendations for the safe handling of parenteral antineoplastic drugs. Washington, DC, US Government Printing Office NIH publication 83-2621.
  2. AMA Council Report. Guidelines for handling parenteral antineoplastics. JAMA. Mar 15, 1985, 253:1590-1592.
  3. National Study Commission on Cytotoxic Exposure: Recommendations for handling cytotoxic agents. Available from Louis P. Jeffrey, ScD, Director of Pharmacy Services, Rhode Island Hospital, 593 Eddy Street, Providence, Rhode Island 02902.
  4. Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Aust. Apr 30, 1983, 1:426-428.
  5. Jones, RB, Frank R, Mass T: Safe handling of chemotherapeutic agents: a report from the Mount Sinai Medical Center. CA. Sept-Oct, 1983, 33:258-263.
  6. ASHP technical assistance bulletin on handling cytotoxic drugs in hospitals. AM J Hosp Pharm. Jan, 1985, 42:131-137.
  7. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm. 1986; 43:1193-1204.

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45914D

Revised: August 2016

PACKAGE LABEL — PRINCIPAL DISPLAY — Floxuridine 500 mg Vial Label
Floxuridine for Injection, USP
500 mg per vial
For intra-arterial use only.
Powder for reconstitution of parenteral solutions.
Rx only

vial
(click image for full-size original)



PACKAGE LABEL — PRINCIPAL DISPLAY — Floxuridine 500 mg Vial Carton Panel
Floxuridine for Injection, USP
500 mg per vial
For intra-arterial use only.
Powder for reconstitution of parenteral solutions. Rx only

carton
(click image for full-size original)
FLOXURIDINE floxuridine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-145
Route of Administration INTRA-ARTERIAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLOXURIDINE (FLOXURIDINE) FLOXURIDINE 500 mg in 5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-145-07 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (63323-145-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075837 03/15/2001
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 manufacture (63323-145)

Revised: 12/2019 Fresenius Kabi USA, LLC

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