Pronunciation:

nye-FYOOR-ti-mix

Brand Names:

• Lampit

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiprotozoal

Uses of This Medicine:

Nifurtimox is used to treat Chagas disease (American Trypanosomiasis) in children.

Chagas disease is a potentially life-threatening disease caused by the protozoan parasite, Trypanosoma cruzi, also known as "kissing bug". It can be transmitted by eating food contaminated with the parasite's feces or urine, blood transfusion from infected donors, organ transplant using organs from infected donors, or during pregnancy or childbirth.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nifurtimox in children weighing at least 2.5 kilograms (kg). Safety and efficacy have not been established in children weighing less than 2.5 kg.

Older adults—

No information is available on the relationship of age to the effects of nifurtimox in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Behavior changes, history of or
• Brain injury, history of or
• Mental problems, history of or
• Porphyria or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease (eg, end stage kidney disease patients receiving dialysis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease—Use with caution. Nifurtimox has not been studied in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully before you start taking nifurtimox and each time you get a refill. Ask your doctor if you have any questions.

Take this medicine with food.

This tablet is scored. You may take it whole or broken at the scored lines. You may cut it in half by hand or as directed by your doctor. Do not break the tablet with a tablet splitting device. To split the tablet:

• Place the tablet on a flat surface with the scored line facing up.
• Apply enough pressure down on the center of the tablet with your index finger to break it in half along the scored line.

For patients who cannot swallow the whole or half tablets, you may dissolve it in water to make a mixture (slurry). To prepare the slurry:

• Place at least one-half teaspoonful (2.5 mL) of water into a spoon.
• Place the prescribed dose into the water and let it dissolve for at least 30 seconds.
• Take the slurry right away with food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For the treatment of Chagas disease:
    • Children—Dose is based on body weight and is usually 8 to 20 milligram (mg) per kilogram (kg) of body weight given 3 times a day for 60 days.
      • Weighing 91 kg or more—300 mg (2 ½120 mg tablets) given 3 times a day for 60 days.
      • Weighing 71 kg to less than 91 kg—240 mg (two 120 mg tablets) given 3 times a day 60 days.
      • Weighing 51 kg to less than 71 kg—180 mg (1 ½ 120 mg tablets given 3 times a day 60 days.
      • Weighing 41 kg to less than 51 kg—120 mg (one 120 mg tablet) given 3 times a day 60 days.
      • Weighing 35 kg to less than 41 kg—180 mg (1 ½ 120 mg tablets) given 3 times a day 60 days.
      • Weighing 27 kg to less than 35 kg—120 mg (four 30 mg tablets or one 120 mg tablet) given 3 times a day 60 days.
      • Weighing 22 kg to less than 27 kg—90 mg (three 30 mg tablets given 3 times a day 60 days.
      • Weighing 18 kg to less than 22 kg—75 mg (2 ½ 30 mg tablets) given 3 times a day 60 days.
      • Weighing 13 kg to less than 18 kg—60 mg (two 30 mg tablets or ½ 120 mg tablet) given 3 times a day 60 days.
      • Weighing 9 kg to less than 13 kg—45 mg (1 ½ 30 mg tablets) given 3 times a day 60 days.
      • Weighing 4.6 kg to less than 9 kg—30 mg (one 30 mg tablet) given 3 times a day 60 days.
      • Weighing 2.5 kg to less than 4.5 kg—15 mg (½ 30 mg tablet) given 3 times a day 60 days.
      • Weighing less than 2.5 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is more than 3 hours from your next scheduled dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is within 3 hours of your next scheduled dose, skip the missed dose and take your next dose at the regular time.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in its original bottle. Keep the bottle tightly closed.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, you must have a negative pregnancy test before you will be allowed to receive this medicine. Female patients should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use an effective form of birth control (eg, condom) during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause vomiting, rash, decreased appetite, fever, and irritability in infants exposed to breast milk. Talk with your doctor if you have any concerns about this.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Serious allergic reactions can occur with this medicine. Check with your doctor right away if you have blurred vision, confusion, dizziness, fast or slow heartbeat, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, itching skin, skin rash, sweating, swelling of the arms, face, legs, lips, tongue, or throat, trouble breathing, unusual tiredness or weakness with this medicine.

Do not drink alcohol during treatment with this medicine.

This medicine may cause nausea and vomiting which can lead to decreased appetite and weight. Check you body weight every 14 days. Your doctor may change your dose if needed.

Nifurtimox may increase your risk for acute attacks of porphyria. Call your doctor right away if you have darkening of the urine, fluid-filled skin blisters, itching of the skin, light-colored stools, skin sensitivity to the sun, skin thinness, or yellow eyes or skin.

This medicine may cause muscle weakness or tremors. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Decreased appetite

diarrhea

dizziness

fever

headache

nausea

stomach pain

vomiting

weight loss

Less common

Black, tarry stools

chest pain

chills

cough

painful or difficult urination

pale skin

sores, ulcers, or white spots on the lips or in the mouth

sore throat

swollen glands

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty in moving

fainting

fear, nervousness

feeling of constant movement of self or surroundings

irritability

joint pain

lack or loss of strength

lower back or side pain

muscle aching or cramping

muscle pains or stiffness

seizure

sensation of spinning

shakiness in the legs, arms, hands, feet

swollen joints

trembling or shaking of the hands or feet

Incidence not known

Agitation

anxiety

bleeding gums

blood in urine or stools

delusions

difficulty swallowing

dry mouth

fast or slow heartbeat

hallucinations

itching, skin rash

lack of feeling or emotion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

loss of memory

numbness, tingling, pain, or weakness in the hands or feet

pinpoint red spots on skin

problems with memory

puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

restlessness

shaking

tightness in the chest

trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.