Fexinidazole (oral)

Fexinidazole (oral)

Fexinidazole (oral)

Uses for Fexinidazole

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

Before using fexinidazole

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Appropriate studies conducted to date have not shown any pediatric-specific problems that would limit the benefit of fexinidazole in children aged 6 years and older and weighing at least 20 kilograms (kg). Safety and effectiveness have not been established in children younger than 6 years or weighing less than 20 kg.

geriatrics

Studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of fexinidazole in the elderly.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Bepridil
• Cisaprid
• Dronedaron
• Ketoconazol
• Levoketoconazol
• Mesoridazin
• Pimozid
• Piperaquin
• Posaconazol
• Saquinavir
• Sparfloxacin
• Terfenadin
• Thioridazin
• Ziprasidon

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

• Abemaciclib
• Abirateronacetat
• Acalabrutinib
• Acebutolol
• Aciclovir
• Adagrasib
• Adefovir
• Alfentanil
• Alfuzosin
• Alprazolam
• Amiodaron
• Amisulprid
• Amitriptylin
• Amlodipin
• Amprenavir
• Anagrelid
• Apalutamid
• Apixaban
• Apomorphin
• Aprepitant
• Aripiprazol
• Aripiprazol Lauroxil
• Armodafinil
• Arsentrioxid
• Asenapin
• Astemizol
• Atazanavir
• Atenolol
• Atorvastatin
• Avanafil
• Avapritinib
• Avatrombopag
• Axitinib
• Azithromycin
• Baricitinib
• Bedaquilin
• Belumosudil
• Benzhydrocodon
• Bevantolol
• Bictegravir
• Bisoprolol
• Boceprevir
• Bosentan
• Bosutinib
• Brigatinib
• Bromocriptin
• Budesonid
• Buprenorphin
• Bupropion
• Buserelin
• Buspiron
• Cabozantinib
• Cannabidiol
• Capmatinib
• Carbamazepin
• Carvedilol
• Celiprolol
• Cenobamat
• Ceritinib
• Chloroquin
• Chlorpromazin
• Cilostazol
• Cimetidin
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimin
• Clomipramin
• Clotiapin
• Clozapin
• Cobicistat
• Cobimetinib
• Kodein
• Colchicin
• Conivaptan
• Copanlisib
• Crizotinib
• Cyclobenzaprin
• Cyclophosphamid
• Cyclosporin
• Dabrafenib
• Daclatasvir
• Dalfampridin
• Darifenacin
• Darolutamid
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delavirdin
• Desipramin
• Deslorelin
• Deutetrabenazin
• Dexamethason
• Dexmedetomidin
• Diazepam
• Dihydroergotamin
• Diltiazem
• Disopyramid
• Disulfiram
• Docetaxel
• Dofetilid
• Dolasetron
• Dolutegravir
• Domperidon
• Donepezil
• Doxepin
• Droperidol
• Duvelisib
• Ebastine
• Efavirenz
• Elagolix
• Elbasvir
• Eletriptan
• Elexacaftor
• Encorafenib
• Entrectinib
• Enzalutamid
• Eplerenon
• Eravacyclin
• Ergotamin
• Eribulin
• Erythromycin
• Escitalopram
• Eslicarbazepinacetat
• Esmolol
• Östradiol
• Eszopiclon
• Etrasimod
• Etravirin
• Everolimus
• Famotidin
• Felbamat
• Felodipin
• Fentanyl
• Finerenon
• Fingolimod
• Flecainid
• Flibanserin
• Fluoxetin
• Fluticason
• Fluvoxamin
• Formoterol
• Fosamprenavir
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostamatinib
• Fostemsavir
• Furosemid
• Galantamin
• Gatifloxacin
• Gemifloxacin
• Gepiron
• Gilteritinib
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Grazoprevir
• Guanfacin
• Halofantrin
• Haloperidol
• Histrelin
• Hydrocodon
• Hydrocortison
• Hydrochinidin
• Hydroxychloroquin
• Hydroxyzin
• Ibrexafungerp
• Ibrutinib
• Ibutilid
• Idelalisib
• Ifosfamid
• Iloperidon
• Imatinib
• Imipramin
• Indinavir
• Inotuzumab Ozogamicin
• Irinotecan
• Irinotecan-Liposom
• Istradefyllin
• Itraconazol
• Ivabradin
• Ivacaftor
• Ivosidenib
• Ixazomib
• Labetalol
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Lercanidipin
• Letermovir
• Leuprolid
• Levamlodipin
• Levofloxacin
• Lofexidin
• Lomitapid
• Lopinavir
• Lorlatinib
• Lovastatin
• Lumacaftor
• Lumateperon
• Lumefantrin
• Lurasidon
• Lurbinectedin
• Macimorelin
• Maraviroc
• Mefloquin
• Metformin
• Methadon
• Methotrimeprazin
• Metoprolol
• Metronidazol
• Mibefradil
• Midazolam
• Mifepriston
• Mitotan
• Mizolastin
• Mobocertinib
• Modafinil
• Moricizin
• Moxifloxacin
• Nadolol
• Nafarelin
• Nafcillin
• Naldemedine
• Naloxegol
• Nateglinid
• Nebivolol
• Nefazodon
• Nelfinavir
• Neratinib
• Netupitant
• Nevirapin
• Nifedipin
• Nilotinib
• Nintedanib
• Nisoldipin
• Norfloxacin
• Octreotid
• Ofloxacin
• Olanzapin
• Omeprazol
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxcarbazepin
• Oxprenolol
• Oxycodon
• Paclitaxel
• Pacritinib
• Palbociclib
• Paliperidon
• Panobinostat
• Papaverin
• Paritaprevir
• Paroxetin
• Pasireotid
• Pazopanib
• Pemigatinib
• Penbutolol
• Pentamidin
• Perampanel
• Perphenazin
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pindolol
• Pipamperon
• Pitolisant
• Ponesimod
• Prednison
• Primidon
• Probukol
• Procainamid
• Prochlorperazin
• Progesteron
• Promethazin
• Propafenon
• Propranolol
• Protriptylin
• Quetiapin
• Chinidin
• Chinin
• Quizartinib
• Ranitidin
• Ranolazin
• Reboxetin
• Relugolix
• Repaglinid
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentin
• Rilpivirin
• Rimegepant
• Ripretinib
• Risperidon
• Ritonavir
• Rivaroxaban
• Rolapitant
• Salmeterol
• Samidorphan
• Saxagliptin
• Selpercatinib
• Selumetinib
• Sertindol
• Sertralin
• Sevofluran
• Sildenafil
• Simeprevir
• Simvastatin
• Sirolimus
• Natriumphosphat
• Natriumphosphat, zweibasisch
• Natriumphosphat, einbasisch
• Solifenacin
• Sonidegib
• Sorafenib
• Sotalol
• Johanniskraut
• Sulpirid
• Sultoprid
• Sunitinib
• Suvorexant
• Tacrolimus
• Tamoxifen
• Tazemetostat
• Telaprevir
• Telavancin
• Telithromycin
• Temsirolimus
• Tepotinib
• Tetrabenazin
• Tezacaftor
• Thiotepa
• Ticagrelor
• Tipranavir
• Tivozanib
• Tizanidin
• Tolterodin
• Tolvaptan
• Toremifen
• Trazodon
• Triclabendazol
• Trimipramin
• Triptorelin
• Valaciclovir
• Vandetanib
• Vardenafil
• Velpatasvir
• Vemurafenib
• Venetoclax
• Venlafaxin
• Verapamil
• Vilanterol
• Vinblastin
• Vincristin
• Vincristinsulfat-Liposom
• Vinflunin
• Vinorelbin
• Voclosporin
• Vorapaxar
• Voriconazol
• Vorinostat
• Voxelotor
• Voxilaprevir
• Zaleplon
• Zolpidem
• Zotepin
• Zuclopenthixol

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine for any of the following conditions is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Ethanol
• Grapefruitsaft

Other medical problems

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

• Herzinsuffizienz, Geschichte von oder
• Herzrhythmusstörungen (z. B. QT-Verlängerung, Torsades de Pointes), Vorgeschichte von oder
• Hypokaliämie (niedriger Kaliumgehalt im Blut), unkorrigiert oder
• Infektion bzw
• Nierenerkrankung, schwere oder
• Psychische Gesundheitsprobleme, Vorgeschichte von oder
• Neutropenie (niedrige weiße Blutkörperchen) – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Lebererkrankung – Sollte bei Patienten mit dieser Erkrankung nicht angewendet werden.

Correct use of fexinidazole

Only take this medicine as directed by your doctor. Do not take more of it, do not take it more often, or take it for longer than your doctor prescribed.

Take this medicine with food at the same time every 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.

dosage

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

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für orale Darreichungsform (Tabletten):
  • Zur Behandlung der afrikanischen Trypanosomiasis (Schlafkrankheit) beim Menschen:
    • Erwachsene und Kinder ab 6 Jahren mit einem Gewicht von 35 Kilogramm (kg) oder mehr – zunächst 1800 Milligramm (mg) (3 Tabletten) einmal täglich über 4 Tage, gefolgt von einer Erhaltungsdosis von 1200 mg (2 Tabletten) einmal pro Tag für 6 Tage.
    • Erwachsene und Kinder ab 6 Jahren mit einem Gewicht von 20 kg bis weniger als 35 kg – zunächst 1200 mg (2 Tabletten) einmal täglich für 4 Tage, gefolgt von einer Erhaltungsdosis von 600 mg (1 Tablette) einmal täglich für 6 Tage.
    • Kinder unter 6 Jahren oder mit einem Gewicht unter 20 kg – Anwendung und Dosierung müssen von Ihrem Arzt festgelegt werden.

Missed dose

If you miss a dose of this medication, skip the missed dose and return to your regular dosing schedule. Do not double the dose.

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. Protect from freezing.

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Precautions when using fexinidazole

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

Do not take this medicine if you have also taken disulfiram in the last 2 weeks.

Call your doctor immediately if your heart rhythm changes. You may feel dizzy, faint, or have a fast, pounding, or irregular heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem, including QT prolongation.

Contact your doctor immediately if you experience a change in your personality or behavior, discouragement, sadness or emptiness, hallucinations, irritability, loss of appetite, loss of interest or joy, nightmares, suicidal thoughts, fatigue, difficulty concentrating, or problems sleeping. These could be symptoms of serious mental health problems.

This medicine reduces the number of some types of blood cells in your body. This can make it easier for infections to occur. To alleviate these problems, avoid being around sick or infected people. Wash your hands often.

Contact your doctor immediately if you or your child have pain or tenderness in the upper abdomen, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of serious liver disease.

This medicine may cause dizziness, sleepiness, or tiredness in some people. Do not drive, use machines, or do anything else that could be dangerous if you feel dizzy or are not alert.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and non-prescription (over-the-counter [OTC]) medicines and herbal (e.g. St. John's wort) or vitamin supplements.

Side effects of fexinidazole

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

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

More common

• Schwarzer, teeriger Stuhl
• Brustschmerzen
• Schüttelfrost
• Verwirrung
• Husten
• Fieber
• Schmerzen im unteren Rücken oder an der Seite
• Stimmungsschwankungen oder mentale Veränderungen
• Muskelkrämpfe in den Händen, Armen, Füßen, Beinen oder im Gesicht
• Taubheitsgefühl und Kribbeln im Mundbereich, an den Fingerspitzen oder an den Füßen
• schmerzhaftes oder schwieriges Wasserlassen
• blasse Haut
• Zittern in den Beinen, Armen, Händen oder Füßen
• Halsentzündung
• Magenschmerzen oder Krämpfe
• Schwellung der Füße oder Unterschenkel
• Zittern oder Zittern der Hände oder Füße
• Atembeschwerden
• Schlafstörungen
• Geschwüre, Wunden oder weiße Flecken im Mund
• ungewöhnliche Blutungen oder Blutergüsse
• ungewöhnliche Müdigkeit oder Schwäche

Less common

• Angst
• verschwommene Sicht
• tiefes oder schnelles Atmen mit Schwindel
• Schwindel
• trockener Mund
• schneller, unregelmäßiger, hämmernder oder rasender Herzschlag oder Puls
• Kopfschmerzen
• Reizbarkeit
• Nervosität
• Taubheitsgefühl in den Füßen, Händen und um den Mund herum
• in den Ohren hämmern
• Unruhe
• zittern

Rarely

• Veränderung der Persönlichkeit
• Verhaltensänderungen
• Entmutigung
• sich traurig oder leer fühlen
• Appetitlosigkeit
• Verlust von Interesse oder Vergnügen
• Dinge sehen, hören oder fühlen, die nicht da sind
• Gedanken daran, sich umzubringen
• Konzentrationsschwierigkeiten

Incident not known

• Ohnmacht
• Albträume

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Saurer oder saurer Magen
• Rücken- oder Nackenschmerzen
• Aufstoßen
• heißes Gefühl
• Sodbrennen
• Verdauungsstörungen
• Mangel oder Verlust der Kraft
• Brechreiz
• Magenbeschwerden, Magenverstimmung oder Schmerzen
• Erbrechen

Less common

• Brennen, Krabbeln, Jucken, Taubheitsgefühl, Kribbeln, „Ameisenlaufen“ oder Kribbeln
• brennendes Gefühl in der Brust oder im Magen
• Veränderung des Farbsehens
• Verstopfung
• Schwierigkeiten beim Sprechen
• Schwierigkeiten beim Sehen in der Nacht
• sabbern
• Völlegefühl oder Völlegefühl
• erhöhte Empfindlichkeit der Augen gegenüber Sonnenlicht
• vermehrtes Schwitzen
• juckende Haut
• Verlust der Gleichgewichtskontrolle
• Muskelkrampf
• Druck im Magen
• Steifheit der Gliedmaßen
• Schwellung des Magenbereichs
• Drehbewegung des Körpers
• unkontrollierte Bewegung, insbesondere von Gesicht, Hals und Rücken

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

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

Available dosage forms:

• Tablette

Therapeutic class: Antiprotozoal agents

Chemical Class: Nitroimidazole

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