Nifurtimox

Paul G. Auwaerter, M.D., Edina Avdic, Pharm.D.

INDICATIONS

FDA

  • Indicated in pediatric patients (birth to under 18 years of age and weighing at least 2.5 kg) for treating Chagas disease (American Trypanosomiasis), caused by .
    Trypanosoma cruzi
    • Per FDA label, “this indication is 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).”

NON-FDA APPROVED USES

  • Treatment of adults with Chagas disease (T. cruzi), especially up to age 50 years, who have chronic infection and lack advanced cardiomyopathy.
  • Adults > 50 years of age with chronic T. cruzi infection, based on shared decision-making, weighing risks and benefits for the patient.

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Last updated: December 1, 2024