Fexinidazole (Oral route)

Pronunciation:

fex-i-NID-a-zole

Dosage Forms:

Tablet

Classifications:

Therapeutic—

Antiprotozoal

Chemical—

Nitroimidazole

Uses of This Medicine:

Fexinidazole is used to treat first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fexinidazole in children 6 years of age and older weighing at least 20 kilograms (kg). Safety and efficacy have not been established in children younger than 6 years of age or weighing less than 20 kg.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fexinidazole in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Cisapride
Dronedarone
Ketoconazole
Levoketoconazole
Mesoridazine
Pimozide
Piperaquine
Posaconazole
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abemaciclib
Abiraterone Acetate
Acalabrutinib
Acebutolol
Acyclovir
Adagrasib
Adefovir
Alfentanil
Alfuzosin
Alprazolam
Amiodarone
Amisulpride
Amitriptyline
Amlodipine
Amprenavir
Anagrelide
Apalutamide
Apixaban
Apomorphine
Aprepitant
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Atenolol
Atorvastatin
Avanafil
Avapritinib
Avatrombopag
Axitinib
Azithromycin
Baricitinib
Bedaquiline
Belumosudil
Benzhydrocodone
Bevantolol
Bictegravir
Bisoprolol
Boceprevir
Bosentan
Bosutinib
Brigatinib
Bromocriptine
Budesonide
Buprenorphine
Bupropion
Buserelin
Buspirone
Cabozantinib
Cannabidiol
Capmatinib
Carbamazepine
Carvedilol
Celiprolol
Cenobamate
Ceritinib
Chloroquine
Chlorpromazine
Cilostazol
Cimetidine
Ciprofloxacin
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clothiapine
Clozapine
Cobicistat
Cobimetinib
Codeine
Colchicine
Conivaptan
Copanlisib
Crizotinib
Cyclobenzaprine
Cyclophosphamide
Cyclosporine
Dabrafenib
Daclatasvir
Dalfampridine
Darifenacin
Darolutamide
Darunavir
Dasatinib
Degarelix
Delamanid
Delavirdine
Desipramine
Deslorelin
Deutetrabenazine
Dexamethasone
Dexmedetomidine
Diazepam
Dihydroergotamine
Diltiazem
Disopyramide
Disulfiram
Docetaxel
Dofetilide
Dolasetron
Dolutegravir
Domperidone
Donepezil
Doxepin
Droperidol
Duvelisib
Ebastine
Efavirenz
Elagolix
Elbasvir
Eletriptan
Elexacaftor
Encorafenib
Entrectinib
Enzalutamide
Eplerenone
Eravacycline
Ergotamine
Eribulin
Erythromycin
Escitalopram
Eslicarbazepine Acetate
Esmolol
Estradiol
Eszopiclone
Etravirine
Everolimus
Famotidine
Felbamate
Felodipine
Fentanyl
Finerenone
Fingolimod
Flecainide
Flibanserin
Fluoxetine
Fluticasone
Fluvoxamine
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosnetupitant
Fosphenytoin
Fostamatinib
Fostemsavir
Furosemide
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Gilteritinib
Glasdegib
Gonadorelin
Goserelin
Granisetron
Grazoprevir
Guanfacine
Halofantrine
Haloperidol
Histrelin
Hydrocodone
Hydrocortisone
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibrexafungerp
Ibrutinib
Ibutilide
Idelalisib
Ifosfamide
Iloperidone
Imatinib
Imipramine
Indinavir
Inotuzumab Ozogamicin
Irinotecan
Irinotecan Liposome
Istradefylline
Itraconazole
Ivabradine
Ivacaftor
Ivosidenib
Ixazomib
Labetalol
Lapatinib
Larotrectinib
Lefamulin
Lemborexant
Lenvatinib
Lercanidipine
Letermovir
Leuprolide
Levamlodipine
Levofloxacin
Lofexidine
Lomitapide
Lopinavir
Lorlatinib
Lovastatin
Lumacaftor
Lumateperone
Lumefantrine
Lurasidone
Lurbinectedin
Macimorelin
Maraviroc
Mefloquine
Metformin
Methadone
Methotrimeprazine
Metoprolol
Metronidazole
Mibefradil
Midazolam
Mifepristone
Mitotane
Mizolastine
Mobocertinib
Modafinil
Moricizine
Moxifloxacin
Nadolol
Nafarelin
Nafcillin
Naldemedine
Naloxegol
Nateglinide
Nebivolol
Nefazodone
Nelfinavir
Neratinib
Netupitant
Nevirapine
Nifedipine
Nilotinib
Nintedanib
Nisoldipine
Norfloxacin
Octreotide
Ofloxacin
Olanzapine
Omeprazole
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Oxcarbazepine
Oxprenolol
Oxycodone
Paclitaxel
Pacritinib
Palbociclib
Paliperidone
Panobinostat
Papaverine
Paritaprevir
Paroxetine
Pasireotide
Pazopanib
Pemigatinib
Penbutolol
Pentamidine
Perampanel
Perphenazine
Phenobarbital
Phenytoin
Pimavanserin
Pindolol
Pipamperone
Pitolisant
Ponesimod
Prednisone
Primidone
Probucol
Procainamide
Prochlorperazine
Progesterone
Promethazine
Propafenone
Propranolol
Protriptyline
Quetiapine
Quinidine
Quinine
Quizartinib
Ranitidine
Ranolazine
Reboxetine
Relugolix
Repaglinide
Ribociclib
Rifabutin
Rifampin
Rifapentine
Rilpivirine
Rimegepant
Ripretinib
Risperidone
Ritonavir
Rivaroxaban
Rolapitant
Salmeterol
Samidorphan
Saxagliptin
Selpercatinib
Selumetinib
Sertindole
Sertraline
Sevoflurane
Sildenafil
Simeprevir
Simvastatin
Sirolimus
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sonidegib
Sorafenib
Sotalol
St John's Wort
Sulpiride
Sultopride
Sunitinib
Suvorexant
Tacrolimus
Tamoxifen
Tazemetostat
Telaprevir
Telavancin
Telithromycin
Temsirolimus
Tepotinib
Tetrabenazine
Tezacaftor
Thiotepa
Ticagrelor
Tipranavir
Tivozanib
Tizanidine
Tolterodine
Tolvaptan
Toremifene
Trazodone
Triclabendazole
Trimipramine
Triptorelin
Valacyclovir
Vandetanib
Vardenafil
Velpatasvir
Vemurafenib
Venetoclax
Venlafaxine
Verapamil
Vilanterol
Vinblastine
Vincristine
Vincristine Sulfate Liposome
Vinflunine
Vinorelbine
Voclosporin
Vorapaxar
Voriconazole
Vorinostat
Voxelotor
Voxilaprevir
Zaleplon
Zolpidem
Zotepine
Zuclopenthixol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Heart failure, history of or
Heart rhythm problems (eg, QT prolongation, torsades de pointes), history of or
Hypokalemia (low potassium in the blood), uncorrected or
Infection or
Kidney disease, severe or
Mental health problems, history of or
Neutropenia (low white blood cells)—Use with caution. May make these conditions worse.

Liver disease—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine with food at the same time each day.

Swallow the tablet whole. Do not break, crush, or chew it.

Do not drink alcohol during treatment and for at least 48 hours after the last dose.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For the treatment of human African trypanosomiasis (sleeping sickness):
  - Adults and children 6 years of age and older weighing 35 kilograms (kg) or more—At first, 1800 milligrams (mg) (3 tablets) once a day for 4 days, followed by a maintenance dose of 1200 mg (2 tablets) once a day for 6 days.
  - Adults and children 6 years of age and older weighing 20 kg to less than 35 kg—At first, 1200 mg (2 tablets) once a day for 4 days, followed by a maintenance dose of 600 mg (1 tablet) once a day for 6 days.
  - Children younger than 6 years of age or weighing less than 20 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you vomit after taking a dose, take the next dose at the regular time.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not take this medicine if you are also taking disulfiram within the last 2 weeks.

Call your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem, including QT prolongation.

Check with your doctor right away if you have change in personality or behavior, discouragement, feeling sad or empty, hallucinations, irritability, lack of appetite, loss of interest or pleasure, nightmares, thoughts of killing oneself, tiredness, trouble concentrating, or trouble sleeping. These could be symptoms of serious mental health problems.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause some people to become dizzy, drowsy, or tired. Do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common: Black, tarry stools; chest pain; chills; confusion; cough; fever; lower back or side pain; mood or mental changes; muscle cramps in the hands, arms, feet, legs, or face; numbness and tingling around the mouth, fingertips, or feet; painful or difficult urination; pale skin; shakiness in the legs, arms, hands, or feet; sore throat; stomach pain or cramps; swelling of the feet or lower legs; trembling or shaking of the hands or feet; trouble breathing; trouble sleeping; ulcers, sores, or white spots in the mouth; unusual bleeding or bruising; unusual tiredness or weakness

Less common: Anxiety; blurred vision; deep or fast breathing with dizziness; dizziness; dry mouth; fast, irregular, pounding, or racing heartbeat or pulse; headache; irritability; nervousness; numbness of the feet, hands, and around the mouth; pounding in the ears; restlessness; shaking

Rare: Change in personality; changes in behavior; discouragement; feeling sad or empty; lack of appetite; loss of interest or pleasure; seeing, hearing, or feeling things that are not there; thoughts of killing oneself; trouble concentrating

Incidence not known: Fainting; nightmares

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Acid or sour stomach; back or neck pain; belching; feeling hot; heartburn; indigestion; lack or loss of strength; nausea; stomach discomfort, upset, or pain; vomiting

Less common: Burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings; burning feeling in the chest or stomach; change in color vision; constipation; difficulty in speaking; difficulty seeing at night; drooling; full or bloated feeling; increased sensitivity of the eyes to sunlight; increased sweating; itching skin; loss of balance control; muscle spasm; pressure in the stomach; stiffness of the limbs; swelling of the stomach area; twisting movement of the body; uncontrolled movement, especially of the face, neck, and back

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Last Updated: 11/16/2023

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