FLUOROURACIL injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

fluorouracil (UNII: U3P01618RT) (fluorouracil - UNII:U3P01618RT)

Available from:

Sagent Pharmaceuticals

INN (International Name):

fluorouracil

Composition:

fluorouracil 50 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluorouracil Injection is indicated for the treatment of patients with: None. Pregnancy Category D Risk Summary There are no adequate and well-controlled studies with fluorouracil in pregnant women. Based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. Administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. Malformations included cleft palate and skeletal defects. In monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see Clinical Pharmacology (12.1)] . Animal Data Malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when fluorouracil was administered by intraperitoneal

Product summary:

Fluorouracil Injection, USP is supplied in a Pharmacy Bulk Package as follows: Fluorouracil Injection, USP, a nucleoside metabolic inhibitor, is a colorless to faint yellow, aqueous, injectable solution available in a pharmacy bulk package, a sterile preparation that contains doses for multiple patients for intravenous administration. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Retain in carton until time of use. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Fluorouracil is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15)] .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOROURACIL INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOROURACIL
INJECTION.
FLUOROURACIL INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL:
1962
RECENT MAJOR CHANGES
Dosage and Administration (2)
07/2016
INDICATIONS AND USAGE
Fluorouracil Injection is a nucleoside metabolic inhibitor indicated
for the treatment of patients with
Adenocarcinoma of the Colon and Rectum (1.1)
Adenocarcinoma of the Breast (1.2)
Gastric Adenocarcinoma (1.3)
Pancreatic Adenocarcinoma (1.4)
DOSAGE AND ADMINISTRATION
Fluorouracil injection is recommended for administration either as an
intravenous bolus or as an intravenous infusion.
(2.1)
See Full Prescribing Information for dose individualization (2.1) and
dose modifications due to adverse reactions (2.6)
See Full Prescribing Information for recommended doses of fluorouracil
injection for adenocarcinoma of the colon and
rectum (2.2) and for recommended doses of fluorouracil injection as a
component of a chemotherapy regimen for
adenocarcinoma of the breast (2.3), gastric adenocarcinoma (2.4),
pancreatic adenocarcinoma (2.5)
Pharmacy Bulk Package: Prepare doses for more than one patient in a
Pharmacy Admixture Service under appropriate
conditions for cytotoxic drugs. Do not inject entire contents of vial
directly into patients. Use within 4 hours of puncture
(2.7, 2.8)
DOSAGE FORMS AND STRENGTHS
Fluorouracil Injection 2.5 grams in a 50 mL bottle and 5 grams in a
100 mL bottle in pharmacy bulk packages (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
INCREASED RISK OF SERIOUS OR FATAL ADVERSE REACTIONS IN PATIENTS WITH
LOW OR ABSENT DIPYRIMIDINE
DEHYDROGENASE ACTIVITY: Withhold or permanently discontinue
fluorouracil in patients with evidence of acute early-
onset or unusually severe toxicity, which may indicate near complete
or total absence of dipyrimidine dehydro