ERGAMISOL^® (levamisole hydrochloride) is only indicated as adjuvant treatment in combination with fluorouracil after surgical resection in patients with Dukes' stage C colon cancer.

The adjuvant use of ERGAMISOL^® (levamisole hydrochloride) and fluorouracil is limited to the following dosage schedule:

Treatment

ERGAMISOL^®, administered orally, should be initiated no earlier than 7 and no later than 30 days post surgery at a dose of 50 mg q8h X 3 days repeated every 14 days for 1 year. Fluorouracil therapy should be initiated no earlier than 21 days and no later than 35 days after surgery providing the patient is out of the hospital, ambulatory, maintaining normal oral nutrition, has well-healed wounds, and is fully recovered from any postoperative complications. If ERGAMISOL^® has been initiated from 7 to 20 days after surgery, initiation of fluorouracil therapy should be coincident with the second course of ERGAMISOL^®, i.e., at 21 to 34 days. If ERGAMISOL^® is initiated from 21 to 30 days after surgery, fluorouracil should be initiated simultaneously with the first course of ERGAMISOL^®. Since the AUC of ERGAMISOL^® is markedly increased in cirrhotic patients, such patients should be observed closely for adverse effects. Dose reduction or discontinuation of ERGAMISOL^® may be warranted if adverse experiences are noted.

Fluorouracil should be administered by rapid IV push at a dosage of 450 mg/m²/day for 5 consecutive days. Dosage calculation is based on actual weight (estimated dry weight if there is evidence of fluid retention). This course should be discontinued before the full 5 doses are administered if the patient develops any stomatitis or diarrhea (5 or more loose stools). Twenty-eight days after initiation of this course, weekly fluorouracil should be instituted at a dosage of 450 mg/m²/week and continued for a total treatment time of 1 year. If stomatitis or diarrhea develop during weekly therapy, the next dose of fluorouracil should be deferred until these side effects have subsided. If these side effects are moderate to severe, the fluorouracil dose should be reduced 20% when it is resumed.

Dosage modifications should be instituted as follows: If WBC is 2500-3500/mm³ defer the fluorouracil dose until WBC is >3500/mm³. If WBC is <2500/mm³, defer the fluorouracil dose until WBC is >3500/mm³; then resume the fluorouracil dose reduced by 20%. If WBC remains <2500/mm³ for over 10 days despite deferring fluorouracil, discontinue administration of ERGAMISOL^®. Both drugs should be deferred unless platelets are adequate (≥100,000/mm³).

ERGAMISOL^® should not be used at doses exceeding the recommended dose or frequency. Clinical studies suggest a relationship between ERGAMISOL^® adverse experiences and increasing dose, and since some of these, e.g. agranulocytosis, may be life-threatening, the recommended dosage regimen should not be exceeded (see WARNINGS).

Before beginning this combination adjuvant treatment, the physician should become familiar with the labeling for fluorouracil.

ERGAMISOL^® (levamisole hydrochloride) is available in white, coated tablets containing the equivalent of 50 mg of levamisole base, debossed "JANSSEN" and "L" "50."

They are supplied in blister packages of 36 tablets (NDC 50458-270-36).

Store at controlled room temperature (59°-77°F/15°-25°C). Protect from moisture.

REFERENCES

1. Laurie A, Moertel CG, Fleming TR, et al. Surgical adjuvant therapy of large-bowel carcinoma: An evaluation of levamisole and the combination of levamisole and fluorouracil. J Clin Oncol. 1989; 7: 1447-1456.

2. Moertel CG, Fleming TR, Macdonald JS, et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. New Engl J Med. 1990; 322: 352-358.

3. Data on file, Janssen Pharmaceutica Inc.

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