Fucil Dosage/Direction for Use

General Directions: 5-FU may be given by IV injection or IV infusion with the latter usually being preferred because of lesser toxicity. Care should be taken to avoid extravasation of the drug. The drug may be administered through a 25-gauge needle.
5-FU (Fucil) does not contain any antimicrobial agent. When used for infusion, 5-FU should be used immediately after dilution. The product is for single use in one patient only. Any residue should be discarded according to the guidelines for the disposal and handling of cytotoxic drugs (see Special Handling Precautions under Cautions for Usage).
The dose of 5-FU is based on the patient's actual weight unless the patient is obese or has fluid retention. In these latter instances, dose is based on ideal weight. Dosage can also be calculated according to body surface area. Dose must be based on the clinical and hematologic response and tolerance of the patient in order to obtain optimum therapeutic results with minimum adverse effects.
Clinicians should consult published protocols for the dosage and the method and sequence of administration of 5-FU and other chemotherapeutic agents.
Usual Adult Dose: As IV Injection: Initial course: 5-FU 12 mg/kg body weight once a day for 4 consecutive days.
If no toxic manifestations are observed, 6 mg/kg body weight is given on days 6, 8, 10, and 12 unless a toxic reaction occurs before then (no therapy is given on days 5, 7, 9, and 11).
The daily dose should not exceed 800 mg in this regimen.
Discontinue on day 12 even if no toxicity has become apparent.
An alternative regimen is 15 mg/kg body weight as a single IV injection once a week throughout the course.
As IV Infusion: 5-FU 15 mg/kg body weight (but not more than 1 g per infusion) diluted in 500 mL of 0.9% sodium chloride or 5% dextrose given once a day at a rate of 40 drops per minute over a period of 4 hours.
The infusion may be repeated on successive days until the first GI side effects (stomatitis and diarrhea) or hematological side effects (e.g., leukopenia or thrombocytopenia) appear or a total of 12 to 15 g has been given.
Alternatively, the daily dose may be infused over 30 to 60 minutes or may be given as a continuous IV infusion over 24 hours.
As Intra-arterial Infusion: 5-FU 5 to 7.5 mg/kg body weight per day may be administered as a 24-hour intra-arterial continuous drip infusion.
Maintenance Therapy: For patients in whom toxicity has not been a problem, the initial therapy should be repeated at intervals of 30 days after the last dose of the previous course.
Alternatively, when toxicity from the initial course of therapy has subsided, a single weekly maintenance of 10 to 15 mg/kg may be administered; weekly maintenance dose should not exceed 1 g.
The dosage schedule to be used in repeated courses depends on the patient's reaction to the previous course and should be adjusted accordingly.
Combination Therapy with Leucovorin: Commonly employed regimen: 5-FU by IV injection at a dose of 370 to 400 mg/m² (9 to 10 mg/kg body weight) for 5 days after administration of leucovorin 200 to 500 mg/m² (5 to 12 mg/kg body weight) for 5 days. Repeat course every 4 weeks.
The patient should be monitored for toxic signs. Drug therapy should be appropriately adjusted or discontinued if toxic signs such as GI bleeding manifest.
Recommendations for Poor Risk Patients: As IV Injection: Initial IV course of 5-FU 240 mg/m² (6 mg/kg body weight) once a day for 3 days.
If no toxic manifestations are observed, 5-FU 3 mg/kg body weight is given on days 5, 7 and 9 unless a toxic reaction occurs before then.
The daily dose should not exceed 400 mg.
Repeat course every 30 days.
As IV Infusion: 5-FU 240 mg/m² (6 mg/kg body weight) diluted in 500 mL of 0.9% sodium chloride or 5% dextrose given once a day over a period of 4 hours, until signs of toxicity are observed, usually within 8 to 15 days.
Renal and Hepatic Impairment: 5-FU should be used with caution in patients with renal or hepatic impairment. Dose adjustment appropriate to the degree of impairment and to the reaction of the patient to the previous 5-FU course should be taken into account.
Treatment with 5-FU should be discontinued promptly whenever any of the following signs of toxicity appears: Stomatitis or esophagopharyngitis, at the first visible sign.
Leukocyte count falls below 3500/mm³ or decreases rapidly.
Platelet count falls below 100,000/mm³.
Granulocyte count falls below 1500/mm³.
Intractable vomiting.
Diarrhea, frequent bowel movements or watery stools.
GI ulceration or bleeding.
Hemorrhage at any site.
Central or peripheral nervous system toxicity, including ataxia and tremor.
Cardiac toxicity.
Dosage Reduction in Combination Therapy: When 5-FU is combined with other antineoplastics of similar toxicity profile or with radiotherapy, the recommended dosage should be adjusted accordingly.