Nifurtimox

What Is nifurtimox?

Nifurtimox (LAMPIT) is a nitrofuran antiprotozoal used to treat Chagas disease caused by the parasite Trypanosoma cruzi in children less than 18 years of age weighing at least 5.5 pounds (2.5 kg).

What are the uses of this medicine?

• This medicine is a prescription medicine used to treat Chagas disease caused by the parasite Trypanosoma cruzi in children less than 18 years of age weighing at least 5.5 pounds (2.5 kg).
• It is not known if LAMPIT is safe and effective in children weighing less than 5.5 pounds (2.5 kg).

How does this medicine work?

• Nifurtimox is an antiprotozoal drug.
• The mechanism of action of nifurtimox is not fully understood.
• Studies suggest that nifurtimox is metabolized/activated, by Type I (oxygen insensitive) and Type II (oxygen sensitive) nitoreductases (NTR) leading to production of toxic intermediate metabolites and/or reactive oxygen species that induce DNA damage and cell death of both intracellular and extracellular forms of T. cruzi.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Patients with known hypersensitivity to nifurtimox or any of the excipients in LAMPIT.
• Patients who consume alcohol during treatment

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

• Take LAMPIT exactly as your healthcare provider tells you.
• Your healthcare provider may change your dose if needed.
• Take your prescribed dose of LAMPIT 3 times a day with food.
• LAMPIT tablets are marked with a scored line. LAMPIT tablets can be taken whole or split at the scored line.
• LAMPIT tablets should be split by hand at the scored line. Do not split LAMPIT tablets using a tablet splitting device.
• If you cannot swallow LAMPIT tablets or you are giving LAMPIT to a child who cannot swallow the tablets, be sure to read the Instructions for Use that come with LAMPIT. LAMPIT tablets can be dissolved in water if whole tablets or half tablets cannot be swallowed.
• If you miss a dose of LAMPIT, take it as soon as possible with food.
• If it is within 3 hours of your next scheduled dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses to make up for a missed dose.

Total Daily Recommended Dosages of LAMPIT Based on Body Weight

• 40 kg or greater:8 to 10 mg/kg
• Less than 40 kg:10 to 20 mg/kg

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 30 mg and 120 mg tablets.

This medicine is available in fallowing brand namesː

• LAMPIT

What side effects can this medication cause?

Common possible side effects of this medicine include:

• vomiting
• abdominal pain
• headache
• decreased appetite
• nausea
• pyrexia
• rash

What special precautions should I follow?

• This medicine may cause Genotoxicity and Carcinogenicity
• Pregnancy testing is recommended for females of reproductive potential.
• Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
• Advise males to use condoms with female partners of reproductive potential.
• Patients with a history of brain injury, seizures, psychiatric disease, serious behavioral alterations may experience worsening of their conditions when receiving LAMPIT.
• Administer LAMPIT under close medical supervision in these patients or if neurological disturbances or psychiatric drug reactions occur.
• Hypersensitivity reactions including hypotension, angioedema, dyspnea, pruritus, rash or other severe skin reactions have been reported with the use of nifurtimox, discontinuation of treatment is recommended.
• Check body weight every 14 days as dosage may need to be adjusted.
• LAMPIT, may precipitate acute attacks of porphyria. Administer LAMPIT under close medical supervision in patients with porphyria.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• LAMPIT may cause fetal harm when administered to a pregnant woman.
• Advise pregnant women of the potential risk to a fetus.
• If LAMPIT is administered during pregnancy, or if a patient becomes pregnant while receiving LAMPIT or within six months following the last dose of LAMPIT, healthcare providers should report LAMPIT exposure by calling 1-888-842-2937.

Can this medicine be used in children?

• The safety and effectiveness of LAMPIT have been established for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi in pediatric patients from birth to less than 18 years of age weighing at least 2.5 kg.
• The safety and effectiveness of LAMPIT has not been established in pediatric patients weighing less than 2.5 kg.

What should I know about storage and disposal of this medication?

• Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
• Store LAMPIT tablets in the original bottle with child-resistant closures and do not remove the desiccant.
• Keep bottle with child-resistant closures tightly closed and protect from moisture.

• Dailymed label info on Nifurtimox
• FDA Nifurtimox