Fluorouracil Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Mechanism of Action
Fluorouracil Indications
Indications
Adenocarcinoma of the breast.
Fluorouracil Dosage and Administration
Adult
Give by IV bolus or IV infusion. Individualize. As a component of a cyclophosphamide-based multidrug regimen: 500mg/m2 or 600mg/m2 on Days 1 and 8 every 28 days for 6 cycles.
Children
Not established.
Fluorouracil Contraindications
Not Applicable
Fluorouracil Boxed Warnings
Not Applicable
Fluorouracil Warnings/Precautions
Warnings/Precautions
Increased risk of serious, including fatal, adverse reactions in patients with certain homozygous or compound heterozygous DPYD variants: not recommended. Withhold or permanently discontinue if evidence of acute early-onset or unusually severe reactions occur. Consider testing for genetic DYPD variants prior to initiation. Hyperammonemic encephalopathy may occur within 72hrs after initiating therapy; withhold and initiate ammonia-lowering therapy if occurs. Withhold if cardiotoxicity, neurologic toxicity, Grade 3/4 diarrhea, Grade 2/3 palmar-plantar erythrodysesthesia (hand-foot syndrome), Grade 4 myelosuppression, or Grade 3/4 mucositis occurs. Monitor CBCs prior to each treatment cycle, weekly if administered on a weekly or similar schedule, and as needed. Embryo-fetal toxicity. Advise females of reproductive potential and males w. female partners to use effective contraception during and for 3 months after the last dose. Pregnancy (Cat. D): may cause fetal harm. Nursing mothers: not recommended.
Fluorouracil Pharmacokinetics
Elimination
Renal. Half-life: 8 to 20 minutes.
Fluorouracil Interactions
Interactions
Potentiated by leucovorin. Monitor closely for INR or prothrombin time with concomitant coumarin-derivative anticoagulants (eg, warfarin).
Fluorouracil Adverse Reactions
Adverse Reactions
Fluorouracil Clinical Trials
See Literature
Fluorouracil Note
Notes
Fluorouracil Patient Counseling
See Literature
Fluorouracil Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Mechanism of Action
Fluorouracil Indications
Indications
Adenocarcinoma of the colon, rectum, and stomach.
Fluorouracil Dosage and Administration
Adult
Give by IV bolus or IV infusion. Individualize. Colon or rectum adenocarcinoma: infusional regimen: (in combination with leucovorin alone or with leucovorin and oxaliplatin or irinotecan): 400mg/m2 via IV bolus on Day 1, then 2400mg/m2 to 3000mg/m2 via continuous infusion over 46 hours every 2 weeks. Bolus dosing regimen: 500mg/m2 via IV bolus on Days 1, 8, 15, 22, 29, and 36 in 8-week cycles. Gastric adenocarcinoma: as a component of a platinum-containing multidrug chemotherapy regimen: 200mg/m2 to 1000mg/m2 via continuous infusion over 24hrs.
Children
Not established.
Fluorouracil Contraindications
Not Applicable
Fluorouracil Boxed Warnings
Not Applicable
Fluorouracil Warnings/Precautions
Warnings/Precautions
Increased risk of serious, including fatal, adverse reactions in patients with certain homozygous or compound heterozygous DPYD variants: not recommended. Withhold or permanently discontinue if evidence of acute early-onset or unusually severe reactions occur. Consider testing for genetic DYPD variants prior to initiation. Hyperammonemic encephalopathy may occur within 72hrs after initiating therapy; withhold and initiate ammonia-lowering therapy if occurs. Withhold if cardiotoxicity, neurologic toxicity, Grade 3/4 diarrhea, Grade 2/3 palmar-plantar erythrodysesthesia (hand-foot syndrome), Grade 4 myelosuppression, or Grade 3/4 mucositis occurs. Monitor CBCs prior to each treatment cycle, weekly if administered on a weekly or similar schedule, and as needed. Embryo-fetal toxicity. Advise females of reproductive potential and males w. female partners to use effective contraception during and for 3 months after the last dose. Pregnancy (Cat. D): may cause fetal harm. Nursing mothers: not recommended.
Fluorouracil Pharmacokinetics
Elimination
Renal. Half-life: 8 to 20 minutes.
Fluorouracil Interactions
Interactions
Potentiated by leucovorin. Monitor closely for INR or prothrombin time with concomitant coumarin-derivative anticoagulants (eg, warfarin).
Fluorouracil Adverse Reactions
Adverse Reactions
Fluorouracil Clinical Trials
See Literature
Fluorouracil Note
Notes
Fluorouracil Patient Counseling
See Literature
Fluorouracil Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Mechanism of Action
Fluorouracil Indications
Indications
Adenocarcinoma of the pancreas.
Fluorouracil Dosage and Administration
Adult
Give by IV bolus or IV infusion. Individualize. In combination with leucovorin or as a component of a multidrug chemotherapy regimen: 400mg/m2 via IV bolus on Day 1, followed by 2400mg/m2 via continuous infusion over 46hrs every 2 weeks.
Children
Not established.
Fluorouracil Contraindications
Not Applicable
Fluorouracil Boxed Warnings
Not Applicable
Fluorouracil Warnings/Precautions
Warnings/Precautions
Increased risk of serious, including fatal, adverse reactions in patients with certain homozygous or compound heterozygous DPYD variants: not recommended. Withhold or permanently discontinue if evidence of acute early-onset or unusually severe reactions occur. Consider testing for genetic DYPD variants prior to initiation. Hyperammonemic encephalopathy may occur within 72hrs after initiating therapy; withhold and initiate ammonia-lowering therapy if occurs. Withhold if cardiotoxicity, neurologic toxicity, Grade 3/4 diarrhea, Grade 2/3 palmar-plantar erythrodysesthesia (hand-foot syndrome), Grade 4 myelosuppression, or Grade 3/4 mucositis occurs. Monitor CBCs prior to each treatment cycle, weekly if administered on a weekly or similar schedule, and as needed. Embryo-fetal toxicity. Advise females of reproductive potential and males w. female partners to use effective contraception during and for 3 months after the last dose. Pregnancy (Cat. D): may cause fetal harm. Nursing mothers: not recommended.
Fluorouracil Pharmacokinetics
Elimination
Renal. Half-life: 8 to 20 minutes.
Fluorouracil Interactions
Interactions
Potentiated by leucovorin. Monitor closely for INR or prothrombin time with concomitant coumarin-derivative anticoagulants (eg, warfarin).
Fluorouracil Adverse Reactions
Adverse Reactions
Fluorouracil Clinical Trials
See Literature
Fluorouracil Note
Notes
Fluorouracil Patient Counseling
See Literature