Fexinidazole Dosage

Usual Adult Dose for Trypanosomiasis

Weight 20 to less than 35 kg:

• Loading dose: 1200 mg orally once a day for 4 days
• Maintenance dose: 600 mg orally once a day for 6 days

Weight at least 35 kg:

• Loading dose: 1800 mg orally once a day for 4 days
• Maintenance dose: 1200 mg orally once a day for 6 days

Use: For the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense

Usual Pediatric Dose for Trypanosomiasis

6 years and older:
Weight 20 to less than 35 kg:

• Loading dose: 1200 mg orally once a day for 4 days
• Maintenance dose: 600 mg orally once a day for 6 days

Weight at least 35 kg:

• Loading dose: 1800 mg orally once a day for 4 days
• Maintenance dose: 1200 mg orally once a day for 6 days

Use: For the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) HAT due to T brucei gambiense

Renal Dose Adjustments

Mild to moderate renal dysfunction (estimated GFR [eGFR] 30 to 89 mL/min/1.73 m2): No adjustment recommended.
Severe renal dysfunction: (eGFR less than 30 mL/min/1.73 m2): Not recommended.

Comments:

• Pharmacokinetics of this drug in patients with severe renal dysfunction are unknown.

Liver Dose Adjustments

Liver dysfunction: Contraindicated

Comments:

• Pharmacokinetics of this drug in patients with liver dysfunction are unknown.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component and/or any nitroimidazole-class drugs (e.g., metronidazole, tinidazole)
• Liver dysfunction

Safety and efficacy have not been established in pediatric patients weighing less than 20 kg and/or patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Health care providers should closely follow patients during treatment.
• Administer with food each day at about the same time of day (e.g., during/immediately after the main meal of the day), to ensure the drug is adequately absorbed.
• Do not break or crush the tablets.
• If vomiting occurs (a first event) after administration of this drug, do not re-dose; administer the next dose the following day using the recommended treatment schedule.
• If a scheduled dose is missed (not administered on the assigned day), resume normal dosing the following day until the full course (10 days) of therapy has been completed.

Storage requirements:

• Store below 30C (86F).
• Store in original package to protect from light and moisture.

General:

• Limitations of Use: Due to the decreased efficacy observed in patients with severe second-stage HAT (cerebrospinal fluid white blood cell count [CSF-WBC] greater than 100 cells/mcL) due to T brucei gambiense, this drug should only be used in such patients if no other treatment options are available.
• The clinical effects of missing multiple doses of this drug are not known.

Monitoring:

• Hematologic: Leukocyte count (periodically)
• Hepatic: Liver-related laboratory tests (at the start and during therapy)

Patient advice:

• Take with food each day at about the same time of the day.
• Do not consume alcoholic beverages during treatment and for at least 48 hours after the last dose.
• Do not administer an additional dose if vomiting occurs after administration of this drug but continue with the next scheduled dose the following day; if vomiting occurs a second time after administration of any other dose of this drug, contact health care provider immediately.
• If a scheduled dose is missed (not taken on the assigned day), resume normal dosing the following day until the full course (10 days) of therapy is finished; contact health care provider immediately if a second scheduled dose is missed.
• Contact health care provider at once if neuropsychiatric side effects (e.g., insomnia, headache, tremor, mood changes, psychiatric disorders [such as agitation, anxiety, abnormal behavior, depression, nightmares, hallucination, personality change], suicidal ideation) occur.
• Dizziness, fatigue, asthenia, and somnolence reported; do not drive or use machines if you feel tired or dizzy.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer