Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; 600 mg) |
| Drug Class | Nitroimidazole antimicrobials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.
Summary
- Fexinidazole (fexinidazole) is a medication used for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT), caused by Trypanosoma brucei gambiense, in patients 6 years of age and older weighing at least 20 kg.
- According to the systematic reviews/meta-analyses reviewed, fexinidazole has been shown to be effective and safe for treating g-HAT infection. It offers convenience over nifurtimox-eflornithine combination therapy due to its oral administration method compared to IV infusion required for NECT.
- The studies indicate that gastrointestinal complaints are common side effects with NECT therapy while convulsions can also occur but are relatively rare; however, these were not reported as significant issues with fexinidazole use.
- There were two Systematic Reviews/Meta-Analyses documents reviewed which provided information on the efficacy and safety of fexinidazole in comparison with other treatments such as eflornithine monotherapy or nifurtimox-eflornithine combination therapy.
- One study suggested that mortality may be higher at 24 months when using fexinidazole compared to NECT although none of these deaths were related directly to treatment; this same study indicated an increase in relapse during follow-up among those treated with fexinidazole versus no relapses noted within the group receiving NECT.
- Despite potential concerns about increased mortality rates or risk of disease recurrence, it was concluded that oral treatment option like Fexindiazole could offer considerable advantages including ease-of-administration, avoidance hospitalization requirements associated intravenous infusions thereby potentially improving patient adherence overall therapeutic regimen especially resource-limited settings where HAT prevalent.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Fexinidazole (fexinidazole) Prescribing Information. | 2021 | Sanofi-Aventis U.S. LLC, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and toxicity of fexinidazole and nifurtimox plus eflornithine in the treatment of African Trypanosomiasis: a systematic review. | 2021 | Cureus |
| Chemotherapy for second-stage human African trypanosomiasis: drugs in use. | 2021 | Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| New WHO guidelines for treatment of gambiense human African trypanosomiasis including fexinidazole: substantial changes for clinical practice. | 2020 | The Lancet Infectious Diseases |
| WHO interim guidelines for the treatment of gambiense human African trypanosomiasis. | 2019 | WHO |