DOSAGE AND ADMINISTRATION
General Instructions
Fluorouracil Injection, USP should be administered only intravenously, using care to avoid extravasation. No dilution is required.
All dosages are based on the patient’s actual weight. However, the estimated lean body mass (dry weight) is used if the patient is obese or if there has been a spurious weight gain due to edema, ascites or other forms of abnormal fluid retention.
It is recommended that prior to treatment each patient be carefully evaluated in order to estimate as accurately as possible the optimum initial dosage of Fluorouracil Injection, USP.
Dosage: Twelve mg/kg are given intravenously once daily for 4 successive days. The daily dose should not exceed 800 mg. If no toxicity is observed, 6 mg/kg are given on the 6th, 8th, 10th and 12th days unless toxicity occurs. No therapy is given on the 5th, 7th, 9th or 11th days. Therapy is to be discontinued at the end of the 12 th day, even if no toxicity has become apparent. (See WARNINGS and PRECAUTIONS sections.)
Poor risk patients or those who are not in an adequate nutritional state (see CONTRAINDICATIONS and WARNINGS sections) should receive 6 mg/kg/day for 3 days. If no toxicity is observed, 3 mg/kg may be given on the 5th, 7th and 9th days unless toxicity occurs. No therapy is given on the 4th, 6th or 8th days. The daily dose should not exceed 400 mg.
A sequence of injections on either schedule constitutes a “course of therapy.”
Maintenance Therapy
In instances where toxicity has not been a problem, it is recommended that therapy be continued using either of the following schedules:
- Repeat dosage of first course every 30 days after the last day of the previous course of treatment.
- When toxic signs resulting from the initial course of therapy have subsided, administer a maintenance dosage of 10 to 15 mg/kg/week as a single dose. Do not exceed 1 gm per week.
The patient’s reaction to the previous course of therapy should be taken into account in determining the amount of the drug to be used, and the dosage should be adjusted accordingly. Some patients have received from 9 to 45 courses of treatment during periods which ranged from 12 to 60 months.
Handling and Disposal
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.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Although the fluorouracil solution may discolor slightly during storage, the potency and safety are not adversely affected. If a precipitate occurs due to exposure to low temperatures, resolubilize by heating to 140°F and shaking vigorously; allow to cool to body temperature before using.
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