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Ergamisol

Brand Name:	Ergamisol	Trade Name:	levamisole
FDA Approved For:	ERGAMISOL (levamisole hydrochloride) is only indicated as adjuvant treatment in combination with fluorouracil after surgical resection in patients with Dukes' stage C colon cancer.	Pediatric Use:	Use Safety and effectiveness of ERGAMISOL in children have not been established.
Carcinogen:	Adequate animal carcinogenicity studies have not been conducted with levamisole. Studies of levamisole administered in drinking water at 5, 20, and 80 mg/kg/day to mice for up to 18 months or administered to rats in the diet at 5, 20, and 80 mg/kg/day for 24 months showed no evidence of neoplastic effects. These studies were not conducted at the maximum tolerated dose, therefore the animals may not have been exposed to a reasonable drug challenge.	Mutagen:	No mutagenic effects were demonstrated in dominant lethal studies in male and female mice, in an Ames test, and in a study to detect chromosomal aberrations in cultured peripheral human lymphocytes.
Manufacturer and/or Distributor:	Janssen Research Foundation

Adverse Reactions:

Almost all patients receiving ERGAMISOL (levamisole hydrochloride) and fluorouracil reported adverse experiences. Tabulated below is the incidence of adverse experiences that occurred in at least 1% of patients enrolled in two clinical trials who were adjuvantly treated with either ERGAMISOL or ERGAMISOL plus fluorouracil following colon surgery. In the larger clinical trial, 66 of 463 patients (14%) discontinued the combination of ERGAMISOL plus fluorouracil because of adverse reactions. Forty-three of these patients (9%) developed isolated or a combination of gastrointestinal toxicities (e.g. nausea, vomiting, diarrhea, stomatitis and anorexia). Ten patients developed rash and/or pruritus. Five patients discontinued therapy because of flu-like symptoms or fever with chills; ten patients developed central nervous system symptoms such as dizziness, ataxia, depression, confusion, memory loss, weakness, inability to concentrate, and headache; two patients developed reversible neutropenia and sepsis; one patient because of thrombocytopenia; one patient because of hyperbilirubinemia. One patient in the ERGAMISOL plus fluorouracil group developed agranulocytosis and sepsis and died. In the ERGAMISOL alone arm of the trial, 15 of 310 patients (4.8%) discontinued therapy because of adverse experiences. Six of these (2%) discontinued because of rash, six because of arthralgia/myalgia, and one each for fever and neutropenia, urinary infection, and cough. (See Table) In worldwide experience with ERGAMISOL, less frequent adverse experiences included exfoliative dermatitis, fixed drug eruptions, periorbital edema, vaginal bleeding, anaphylaxis, confusion, convulsions, hallucinations, impaired concentration, renal failure, pancreatitis, elevated serum creatinine, and increased alkaline phosphatase. Reports of hyperlipidemia have been observed in patients receiving combination therapy of ERGAMISOL and fluorouracil; elevations in triglyceride levels have been greater than increases in cholesterol levels. In worldwide postmarketing experience with the combination therapy, there have been rare cases of elevated hepatic enzymes and hepatosteatosis in patients. The following additional adverse experiences have been reported for fluorouracil alone: esophagopharyngitis, pancytopenia, myocardial ischemia, angina, gastrointestinal ulceration and bleeding, anaphylaxis and generalized allergic reactions, acute cerebellar syndrome, nystagmus, dry skin, fissuring, photosensitivity, lacrimal duct stenosis, photophobia, euphoria, thrombophlebitis, and nail changes. )

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