Fexinidazole (fex-i-NID-a-zole)

Treats human African trypanosomiasis (sleeping sickness).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine at the same time each day.
• It is best to take this medicine with food or milk.
• Swallow the tablet whole. Do not break, crush, or chew it.
• Missed dose: If you miss a dose or vomit after taking a dose, skip the missed dose and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take this medicine if you are also taking disulfiram within the last 2 weeks.
• Some medicines can affect how fexinidazole works. Tell your doctor if you are using any of the following:
  • Adefovir, astemizole, carbamazepine, diazepam, efavirenz, lansoprazole, lovastatin, mephenytoin, metformin, midazolam, nisoldipine, phenytoin, rifampin, saquinavir, simvastatin, tacrine, terfenadine, theophylline, tizanidine, St John's wort
  • Diuretic (water pill, including furosemide)
  • Medicine to treat depression (including bupropion, duloxetine, TCAs)
  • Medicine to treat an infection (including cefaclor, clarithromycin, erythromycin, fluconazole, itraconazole, voriconazole)
  • Medicine to treat heart rhythm problems (including dofetilide)
  • Phenothiazine medicine
• Do not drink alcohol while you are using this medicine. Do not drink alcohol for at least 48 hours after the last dose.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, any type of infection, or a history of heart rhythm problems (including QT prolongation, torsades de pointes), heart failure, or mental health problems.
• This medicine may cause the following problems:
  • Heart rhythm problems
  • Unusual thoughts or behavior (including anxiety, depression, hallucinations, suicidal thoughts)
  • Liver problems
• This medicine may make you dizzy, drowsy, or feel tired. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, depression, changes in mood or behavior, seeing, hearing, or feeling things that are not there, thoughts of hurting oneself
• Confusion, muscle cramps or spasms, numbness and tingling around the mouth, fingertips, or feet, seizures, tremor
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat, weakness or heaviness of the legs
• Fever, chills, cough, sore throat, body aches
• Trouble sleeping

If you notice these less serious side effects, talk with your doctor:

• Back pain
• Headache
• Stomach upset
• Tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088