Nifurtimox

Nifurtimox – Description

Nifurtimox is an oral antiprotozoal agent used for the treatment of American trypanosomiasis (Chagas disease) caused by Trypanosoma cruzi, a disease that is rare in the US.
Cases may occur in laboratory workers, immigrants, and US citizens returning from travel to Latin America. Nifurtimox is only FDA-approved in pediatric patients from birth to 17 years; however, it is used off-label in all populations.⁶²²⁸³
The efficacy of nifurtimox was demonstrated in pediatric patients 0 to 4 years of age in a prospective, randomized, double-blind trial based on seroconversion to negative confirmed on 3 assays (lysate ELISA, recombinant ELISA, and IHA) at 4 years post-treatment compared to untreated patients.
The efficacy of nifurtimox in pediatric patients 5 to 17 years of age was extrapolated from efficacy established in the younger pediatric population as it is expected that nifurtimox would have the same effect on T. cruzi in all pediatric age groups.
Supportive evidence of efficacy was provided by data on seroconversion to negative by the F29 ELISA. Of note, based on published studies, younger pediatric patients seroconvert faster.
Older pediatric patients may have a longer duration of infection than younger patients, and thus the time to seroconversion is expected to be longer in these patients.
It is expected that seroconversion rates would increase in older pediatric age groups over time.⁶⁵⁸⁰³ Nifurtimox is also used off-label for the treatment of African trypanosomiasis (sleeping sickness) due to Trypanosoma brucei gambiense with CNS involvement in combination with eflornithine.⁶²³⁷²

Indications

African trypanosomiasis (sleeping sickness)†
American trypanosomiasis (Chagas disease)
Trypanosoma brucei gambiense
Trypanosoma cruzi

Dosage

General dosing information:

Check body weight every 14 days during treatment to ensure the correct dosage of nifurtimox is administered. Decreased appetite and weight loss were reported in patients treated with nifurtimox in clinical trials.⁶⁵⁸⁰³

This drug may also have activity against the following microorganisms: Trypanosoma brucei gambiense, Trypanosoma cruzi

NOTE: Some organisms may not have been adequately studied during clinical trials; therefore, exclusion from this list does not necessarily negate the drug’s activity against the organism.

For the treatment of American trypanosomiasis (Chagas disease)

Oral dosage

Adults†:

8 to 10 mg/kg/day (Max: 900 mg/day) PO divided 3 times daily for 60 days.³⁴³⁶² ⁶²²⁸³ ⁶⁵⁸⁰³

Adolescents weighing 91 kg or more:

8 to 10 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 300 mg PO 3 times daily is recommended.³⁴³⁶² ⁶²²⁸³ ⁶⁵⁸⁰³

Adolescents weighing 71 to 90 kg:

8 to 10 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 240 mg PO 3 times daily is recommended.³⁴³⁶² ⁶²²⁸³ ⁶⁵⁸⁰³

Children and Adolescents weighing 51 to 70 kg:

8 to 10 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 180 mg PO 3 times daily is recommended.³⁴³⁶² ⁶²²⁸³ ⁶⁵⁸⁰³

Children and Adolescents weighing 41 to 50 kg:

8 to 10 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 120 mg PO 3 times daily is recommended.³⁴³⁶² ⁶²²⁸³ ⁶⁵⁸⁰³

Children and Adolescents weighing 35 to 40 kg:

10 to 20 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 180 mg PO 3 times daily is recommended.³⁴³⁶² ⁶²²⁸³ ⁶⁵⁸⁰³

Children and Adolescents weighing 27 to 34 kg:

10 to 20 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 120 mg PO 3 times daily is recommended.³⁴³⁶² ⁶²²⁸³ ⁶⁵⁸⁰³

Children weighing 22 to 26 kg:

10 to 20 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 90 mg PO 3 times daily is recommended.⁶²²⁸³ ⁶⁵⁸⁰³

Children weighing 18 to 21 kg:

10 to 20 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 75 mg PO 3 times daily is recommended.⁶²²⁸³ ⁶⁵⁸⁰³

Children weighing 13 to 17 kg:

10 to 20 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 60 mg PO 3 times daily is recommended.⁶²²⁸³ ⁶⁵⁸⁰³

Infants and Children weighing 9 to 12 kg:

10 to 20 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 45 mg PO 3 times daily is recommended.⁶²²⁸³ ⁶⁵⁸⁰³

Term Neonates and Infants weighing 4.6 to 8 kg:

10 to 20 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 30 mg PO 3 times daily is recommended.⁶²²⁸³ ⁶⁵⁸⁰³

Term Neonates and Infants weighing 2.5 to 4.5 kg:

10 to 20 mg/kg/day PO divided 3 times daily for 60 days; for ease of administration, a dose of 15 mg PO 3 times daily is recommended.⁶²²⁸³ ⁶⁵⁸⁰³

For the treatment of second-stage (meningoencephalitic) African trypanosomiasis (sleeping sickness)† due to T. brucei gambiense

Oral dosage

Adults:

5 mg/kg/dose PO every 8 hours for 10 days in combination with eflornithine (NECT).⁶²³⁷² ⁶⁶⁸¹³

Infants, Children, and Adolescents:

5 mg/kg/dose PO every 8 hours for 10 days in combination with eflornithine (NECT).⁶²³⁷² ⁶⁶⁸¹³

Maximum Dosage Limits:

•Adults

Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO have been used off-label.

•Geriatric

Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO have been used off-label.

•Adolescents

weight 41 kg or more: 10 mg/kg/day PO (Max: 900 mg/day) is FDA-approved maximum; however, doses up to 15 mg/kg/day PO have been used off-label.

weight less than 41 kg: 20 mg/kg/day PO.

•Children

weight 41 kg or more: 10 mg/kg/day PO (Max: 900 mg/day) is FDA-approved maximum; however, doses up to 15 mg/kg/day PO have been used off-label.

weight less than 41 kg: 20 mg/kg/day PO.

•Infants

20 mg/kg/day PO.

•Neonates

weight 2.5 kg or more: 20 mg/kg/day PO.

weight less than 2.5 kg: Safety and efficacy have not been established.

Contraindications

Ethanol ingestion

Precautions

activities requiring coordination and concentration
brain injury
breast-feeding
driving or operating machinery
people who can cause pregnancy in others
people who may become pregnant
porphyria
pregnancy
psychiatric disorder
reproductive risk
seizures

Interactions

Ethanol

Adverse Reactions of Nifurtimox

abdominal pain
agitation
amnesia
anemia
angioedema
anorexia
anxiety
arthralgia
asthenia
diarrhea
dizziness
drowsiness
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
dyspnea
edema
eosinophilia
fatigue
fever
genotoxicity
headache
hypotension
irritability
laryngeal edema
leukopenia
maculopapular rash
myalgia
myasthenia
nausea
neutropenia
paresthesias
pruritus
rash
seizures
syncope
thrombocytopenia
tremor
urticaria
vertigo
vomiting
weight loss

Monitoring Parameters

Pregnancy testing
Weight

Classifications

General Anti-infectives Systemic
- Antiparasitic Agents, Insecticides, and Repellants
  - Antiprotozoals
    - Agents for Leishmaniasis and/or Trypanosomiasis

Global Drug Names

Argentina
- Furtimox – (Gador)
Chile
- Lampit – (Bayer)
Germany
- Lampit – (Bayer)

References

34362.Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV. Accessed March 17, 2025. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection.

62283.Centers for Disease Control and Prevention (CDC). Parasites-American Trypanosomiasis (also known as Chagas disease); Antiparasitic treatment. Accessed May 25, 2021. Available on the World Wide Web at https://www.cdc.gov/parasites/chagas/health_professionals/tx.html.

62372.Centers for Disease Control and Prevention (CDC). Clinical Care of Human African Trypanosomiasis. Updated December 2024. Accessed May 16, 2025. Available on the World Wide Web at https://www.cdc.gov/sleeping-sickness/hcp/clinical-care/index.html.

65604.Ablysinol (dehydrated alcohol injection) package insert. Largo, FL: Belcher Pharmaceuticals, LLC; 2018 Jun.

65702.Dehydrated alcohol injection package insert. Lake Forest, IL: Akorn, Inc. 2017 Nov.

65803.Lampit (nifurtimox) tablets package insert. Whippany, NJ: Bayer Healthcare Pharmaceuticals, Inc.; 2023 Jun.

66813.World Health Organization. WHO interim guidelines for the treatment of gambiense human African trypanosomiasis. Geneva: World Health Organization; 2019. Retrieved July 19, 2021. Available on the World Wide Web at: https://www.who.int/health-topics/human-african-trypanosomiasis#tab=tab_3.

Chagas Disease