General Information

Lampit (nifurtimox) is a a nitrofuran antiprotozoal.

Lampit is specifically indicated for use in pediatric patients (birth to less than 18 years of age and weighing at least 2.5 kg) for the treatment of Chagas disease (American Trypanosomiasis) caused by Trypanosoma cruzi.

Lampit is supplied as a tablet for oral administration. Lampit (30 mg and 120 mg) tablets are for oral use and must be taken with food. Lampit (30 mg and 120 mg) tablets are functionally scored tablets which can be split into one-half (15 mg and 60 mg respectively) at the scored lines by hand. Do not break Lampit tablets mechanically with a tablet splitting device. Lampit 30 mg and 120 mg tablets can be made into a slurry as an alternative method of administration for patients who cannot swallow the tablets. Discontinue consumption of alcohol during treatment with Lampit .Complete the full course of treatment to prevent recurrence of the infection. If a dose is missed, take the missed dose as soon as possible together with food. However, if it is within 3 hours of the next scheduled dose, skip the missed dose and continue treatment as prescribed. Do not take a double dose to make up for a missed dose. 

Total daily recommended dosages of Lampit are based on the body weight of the patient. The recommended duration is 60 days. Please see drug label for weight-based dosing recommendations.

Mechanism of Action

Lampit (nifurtimox) is a a nitrofuran antiprotozoal. 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. Antimicrobial Activity Nifurtimox is active against all three stages, trypomastigotes, amastigotes, and epimastigotes, of T. cruzi. However, the sensitivity of T. cruzi strains to nifurtimox, from different geographic regions, may vary.

Side Effects

Adverse effects associated with the use of Lampit may include, but are not limited to, the following:

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

Clinical Trial Results

Lampit was approved under accelerated approval based on the number of treated patients who became immunoglobulin G (IgG) antibody negative or who showed an at least 20% decrease in optical density on two different IgG antibody tests against antigens of T. cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The FDA approval was based on results from the Chagas disease in children treated with nifurtimox study. The prospective, randomized (to dosing regimen), double-blind study assessed the efficacy, safety, and pharmacokinetics of nifurtimox in 330 children with Chagas disease. The study was conducted at 25 investigational sites in Argentina, Bolivia, and Colombia between 2016 and 2018. In the study, 330 pediatric patients with serologic evidence of T. cruzi infection (without Chagas disease-related cardiovascular and/or gastrointestinal symptoms) were randomly assigned in a 2:1 fashion to receive either a 60-day (n=219) or a 30-day (n=111) Lampit treatment regimen, and were followed up for one year after end of treatment. The results showed superiority in favor of the nifurtimox 60-day arm compared to the nifurtimox 30-day arm (not an approved dosing regimen).