Fexinidazole (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- FEXINIDAZOLE
Indications and Usage
Fexinidazole Tablets are indicated for the treatment of both the 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.
Contraindications
Fexinidazole Tablets are contraindicated in: Patients with known hypersensitivity to Fexinidazole Tablets and/or any nitroimidazole-class drugs (e.g., metronidazole, tinidazole). Patients with severe hepatic impairment [see Warnings and Precautions (5.5), Adverse Reactions (6.1), and Use in Specific Populations (8.7)]. Patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to fexinidazole, in patients with Cockayne syndrome [see Adverse Reactions (6.2)].
Adverse Reactions
The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Decreased Efficacy in Severe Human African Trypanosomiasis Caused by Trypanosoma brucei gambiense [see Warnings and Precautions (5.1)] QT Interval Prolongation [see Warnings and Precautions (5.2)] Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.3)] Neutropenia [see Warnings and Precautions (5.4)] Potential for Hepatotoxicity [see Warnings and Precautions (5.5)]
Mechanism of Action
Fexinidazole is an antiprotozoal drug [see Microbiology (12.4)].
Overdosage
Randomized, controlled clinical studies were conducted in normal adult male subjects who were administered single or multiple oral doses of fexinidazole of up to 3,600 mg daily for 14 days (not an approved dose). The subjects experienced adverse reactions of increased transaminases, vomiting and panic attack [see Adverse Reactions (6.1)]. Reported symptoms of overdosage in a pediatric HAT patient following ingestion of a higher than recommended dosing regimen in Trial 3 included vomiting over the first 5 days of treatment and increased potassium and decreased calcium levels from Day 11 to Week 9. There is no specific antidote for Fexinidazole Tablets. Treatment should be supportive with appropriate monitoring.