FLUOROURACIL injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

FLUOROURACIL (UNII: U3P01618RT) (FLUOROURACIL - UNII:U3P01618RT)

Dostupno od:

Gland Pharma Limited

INN (International ime):

FLUOROURACIL

Sastav:

FLUOROURACIL 50 mg in 1 mL

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Fluorouracil is indicated for the treatment of patients with: 1.1 Adenocarcinoma of the Colon and Rectum 1.2 Adenocarcinoma of the Breast 1.3 Gastric Adenocarcinoma 1.4 Pancreatic Adenocarcinoma  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 injection to mice at doses at or above 10 mg/kg (approximately 0.06 times a human dose of 12 mg/kg on a mg/m2 basis) for 4 days during the period of organogenesis. Similar results were observed in hamsters administered fluorouracil intramuscularly at doses lower than those administered in commonly used clinical treatment regimens. In rats, administration of fluorouracil by intraperitoneal injection at doses greater than 15 mg/kg (approximately 0.2 times a human dose of 12 mg/kg on a mg/m2  basis) for a single day during organogenesis resulted in delays in growth and malformations including microanophthalmos. In monkeys, administration of fluorouracil during organogenesis at doses approximately equal to a human dose of 12 mg/kg on a mg/m2  basis resulted in abortion; at a 50% lower dose, resorptions and decreased fetal body weights were reported. It is not known whether fluorouracil or its metabolites are present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from fluorouracil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness in pediatric patients have not been established. Reported clinical experience has not identified differences in safety or effectiveness between the elderly and younger patients. Contraception Females Based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with fluorouracil and for up to 3 months following cessation of therapy [see Use in Specific Populations (8.1)]. Males Fluorouracil may damage spermatozoa. Advise males with female partners of reproductive potential to use effective contraception during and for 3 months following cessation of therapy with fluorouracil [see Nonclinical Toxicology (13.1)].   Infertility Females Advise females of reproductive potential that, based on animal data, fertility may be impaired while receiving fluorouracil [see Nonclinical Toxicology (13.1)].   Males Advise males of reproductive potential that, based on animal data, fertility may be impaired while receiving fluorouracil [see Nonclinical Toxicology (13.1)].

Proizvod sažetak:

Fluorouracil injection is supplied in single dose vial available in a box containing ten vials, as listed below: • NDC 68083-269-10: one box with ten vials, containing 500 mg/10 mL (50 mg/mL) fluorouracil • NDC 68083-270-10: one box with ten vials, containing 1 g/20 mL (50 mg/mL) fluorouracil Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Fluorouracil is a cytotoxic drug. Follow applicable special handling and disposable procedures [see References (15)].

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

FLUOROURACIL - FLUOROURACIL INJECTION, SOLUTION
GLAND PHARMA LIMITED
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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
Warnings and Precautions, Serious Adverse Reactions from
Dihydropyrimidine Dehydrogenase (DPD)
Deficiency (5.1) 01/2024
INDICATIONS AND USAGE
Fluorouracil 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) (1)
DOSAGE AND ADMINISTRATION
• Fluorouracil 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 for adenocarcinoma of the colon
and rectum (2.2) and for recommended doses of fluorouracil as a
component of a chemotherapy regimen
for adenocarcinoma of the breast (2.3), gastric adenocarcinoma (2.4),
pancreatic adenocarcinoma (2.5)
(2)
DOSAGE FORMS AND STRENGTHS
Injection: 500 mg in a 10 mL vial in Single dose vial (3)
1 g in a 20 mL vial in Single dose vial (3) (3)
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
• SERIOUS ADVERSE REACTIONS FROM DIHYDROPYRIMIDINE DEHYDROGENASE
(DPD) DEFICIENCY:
Patients with certain homozygous or compound heterozygous variants in
the DPYD gene are at increased
risk for acute early-onset toxicity and serious, including fatal,
adverse reactions due to fluorouracil (e.g.,
mucositis, diarrhea, neutropenia, and neurotoxicity). Fluorouracil is
not recommended for use in patients
known to have certain homozygous or compound heterozygous DPYD
variants that result in compl