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.

Further information

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

Medical Disclaimer