Description
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.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fexinidazole in the elderly.
Breastfeeding
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.
Drug Interactions
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
- Fezolinetant
- Ketoconazole
- Levoketoconazole
- Mavacamten
- 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
- Abiraterone Acetate, Micronized
- 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
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
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.
- For the treatment of human African trypanosomiasis (sleeping sickness):
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
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
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.
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