Levamisole Hydrochloride

• Type of Drug: Immune-system modulator.
• Prescribed for: Duke’s stage C colon cancer, together with Fluorouracil. Levamisole is also prescribed for malignant melanoma after surgery in people in whom the disease has not spread.

Levamisole Hydrochloride General Information

Levamisole, used to cure worm infections in animals, was found to restore depressed immune function in people. It can stimulate the formulation of antibodies to various agents, enhance T-cell response by stimulating and activating these important immune-system cells, and stimulate the functions of various white-blood-cell types (including their infectionfighting capability). The exact way that it works in concert with Fluorouracil is not known. In one clinical study of Levamisole, the survival rate of Duke’s C colon cancer patients was improved by 27 percent for Levamisole plus Fluorouracil and 28 percent for Levamisole alone. The reduced recurrence rate for the disease was 36 percent for the drug combination; and 28 percent for Levamisole alone. Another study showed 33 percent improved survival and 41 percent reduction in disease recurrence for the 2 medicines. The drug is broken down in the liver and passes out of the body through the kidneys.

Levamisole Hydrochloride Cautions and Warnings

Do not take Levamisole if you are allergic to this drug or have had an allergic reaction to it. People taking Levamisole may develop agranulocytosis, a potentially fatal reduction in white-blood-cell levels. Common symptoms of agranulocytosis are fever, chills, and flu-like symptoms; agranulocytosis can develop suddenly and without warning. Regular blood monitoring is necessary while you are on Levamisole: Your doctor may suddenly stop treatment if blood tests indicate the development of this problem, which may reverse when you stop the medicine.

Possible Side Effects

Virtually all people taking Fluorouracil and Levamisole experience some side effects. Often, side effects are due to either one or both of the drugs, and the actual source of some side effects may not be distinguishable. In Levamisole studies, the most common reasons for people stopping drug treatment were (in order) rash, joint and muscle aches, fever, white-blood-cell depression, urinary infection, and cough.

• Most common: nausea, vomiting, diarrhea, mouth sores, appetite loss, abdominal pains, constipation, a metallic taste, joint and muscle aches, dizziness, headache, tingling in the hands or feet, white-blood-cell reductions, rash, hair loss, fatigue, sleepiness, fever, chills, and infections.
• Less common: reduced platelet levels, itching, stomach upset, stomach gas, changes in sense of smell, depression, nervousness, sleeplessness, anxiety, blurred vision, and red eyes.
• Rare: peeling rashes, swelling around the eyes, vaginal bleeding, severe allergic reactions (breathing difficulty, skin rash, or itching), confusion, convulsions, hallucinations, loss of concentration, and kidney failure.

Drug Interactions

• People taking Levamisole who drink alcoholic beverages may experience severe reactions. Avoid this combination.
• People taking Phenytoin who also take combined therapy with Fluorouracil and Levamisole may have higher than usual levels of Phenytoin in their blood, increasing the chances for drug side effects.

Food Interactions

None known.

Usual Dose

Colon Cancer
50 mg every 8 hours for 3 days starting 7 to 30 days after surgery; then 50 mg every 8 hours for 3 days every 2 weeks.

Malignant Melanoma
2 ½ mg once daily for 2 consecutive days each week.

Levamisole Hydrochloride Overdosage

A Levamisole dosage was fatal in a child who took the equivalent of 6.8 mg per pound of body weight. An adult died after taking 14.5 mg per pound (usually adults take about 0.5 to 1 mg per pound). The most likely symptoms of overdose are exaggerated side effects, including those that affect the blood system, stomach, and intestines. Overdose victims should be taken to a hospital emergency room at once. ALWAYS bring the medicine bottle with you.

Special Information

Call your doctor if you develop any side effects, especially fever, chills, or flulike symptoms. Taking more than the recommended dose of Levamisole increases side-effect risk without improving the drug’s effectiveness. Carefully follow your doctor’s directions.
If you forget a dose of Levamisole, do not take the forgotten medication and do not take a double dose. Call your doctor for more information.

Levamisole Hydrochloride Special Populations

Pregnancy/Breast-feeding
While there is no direct information on pregnancy in humans, animal studies indicate that Levamisole may damage a growing fetus. If you are pregnant, do not take this drug unless you have fully discussed all available options and the possible risks and benefits of Levamisole with your doctor. Use effective contraceptive measures to be sure you don’t become pregnant while taking Levamisole and Fluorouracil.
Levamisole may pass into breast milk. Nursing mothers who must take Levamisole should bottle-feed their babies.

Seniors
Seniors may take this medicine without special restriction. Report any side effects to your doctor.