No

Immune Modulator

Adjuvant treatment with fluorouracil in Dukes stage C colon cancer

C

Previous hypersensitivity to the drug

Agranulocytosis can occur asymptomatically and flu-like symptoms can occur without hematologic adverse effects; frequent hematologic monitoring is necessary

>10%: Gastrointestinal: Nausea, diarrhea

1% to 10%:

Cardiovascular: Edema

Central nervous system: Fatigue, fever, dizziness, headache, somnolence, depression, nervousness, insomnia

Dermatologic: Dermatitis, alopecia

Gastrointestinal: Stomatitis, vomiting, anorexia, abdominal pain, constipation, taste perversion

Hematologic: Leukopenia

Neuromuscular & skeletal: Rigors, arthralgia, myalgia, paresthesia

Miscellaneous: Infection

<1%: Chest pain, anxiety, pruritus, urticaria, flatulence, dyspepsia, thrombocytopenia, anemia, granulocytopenia, abnormal tearing, blurred vision, conjunctivitis, epistaxis, altered sense of smell, Stevens-Johnson syndrome

Treatment following decontamination is symptomatic and supportive

Increased toxicity/serum levels of phenytoin

Disulfiram-like reaction with alcohol

Clinically, combined therapy with levamisole and 5-fluorouracil has been effective in treating colon cancer patients, whereas demonstrable activity has been demonstrated. Due to the broad range of pharmacologic activities of levamisole, it has been suggested that the drug may act as a biochemical modulator (of fluorouracil, for example, in colon cancer), an effect entirely independent of immune modulation. Further studies are needed to evaluate the mechanisms of action of the drug in cancer patients.

Absorption: Well absorbed

Metabolism: In the liver, >70%

Half-life, elimination: 2-6 hours

Time to peak serum concentration: 1-2 hours

Elimination: In urine and feces; elimination is virtually complete within 48 hours after an oral dose

Adults: Oral: Initial: 50 mg every 8 hours for 3 days, then 50 mg every 8 hours for 3 days every 2 weeks (fluorouracil is always given concomitantly)

CBC with platelet count prior to therapy and weekly prior to treatment; LFTs every 3 months

May cause sedation, dizziness, depression, nervousness, or insomnia

May produce leukopenia; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Take as directed, at regular intervals around-the-clock. Avoid alcohol (may cause disulfiram-like effect). Avoid all aspirin-containing medications. You may experience GI upset (small frequent meals may help); diarrhea (request medication); sensitivity to sun (use sunblock, wear protective clothing, and avoid direct sun); or dizziness, drowsiness, or impaired judgment (use caution when driving, climbing stairs, or engaging in tasks requiring alertness until response to drug is known). You will be more susceptible to infection; avoid crowds or infected persons. Report chills or fever, confusion, persistent or violent vomiting, persistent diarrhea, or respiratory difficulty. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Do not breast-feed.

Monitor CBC with platelets prior to therapy and weekly prior to treatment; LFTs every 3 months

Tablet, as base: 50 mg

Graziani G and De Martin GL, "Pharmacokinetic Studies on Levamisol: On the Pharmacokinetics and Relative Bioavailability of Levamisole in Man," Drugs Exp Clin Res, 1977, 2(1):235-40.

Greenspan EM and Erlich R, "Levamisol and the New Era of Chemoimmunotherapy," Cancer Invest, 1991, 9(1):111-24.

Renoux G, "The General Immunopharmacology of Levamisol," Drugs, 1980, 20:89-99.

Schnieden H, "Levamisol - A General Pharmacological Perspective," Int J Immunopharmacol, 1981, 3(1):9-13.

Spreafico F, "Use of Levamisole in Cancer Patients," Drugs, 1980, 20(2):105-16.