Approved for treatment of pediatric patients with Chagas disease (American Trypanosomiasis) (caused by Trypanosoma cruzi ).
Accelerated approval. Continued approval for this indication in pediatric patients may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Patients with a history of brain injury, seizures, psychiatric disease, or serious behavioral alterations may experience worsening of their conditions when receiving nifurtimox. Administer nifurtimox under close medical supervision in these patients and in patients who develop neurological disturbances or psychiatric drug reactions.
Nifurtimox has previously been used to treat Chagas disease, mainly in adults, prior to its 2020 FDA approval.
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