Nifurtimox

Nifurtimox is used to treat Chagas disease (an infection caused by a parasite) in children from birth to 18 years old who weigh at least 5.5 pounds (2.5 kg). Nifurtimox is in a class of medications called antiprotozoals. It works by killing the organism that can cause Chagas disease.

Nifurtimox comes as a tablet to take by mouth. It is usually taken with food three times a day for 60 days. Take nifurtimox at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nifurtimox exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

The nifurtimox tablets are scored so that they can easily be split into halves. If your doctor has told you to take only part of a tablet, hold the tablet between your thumb and index fingers close to the scored line and apply pressure to separate the dose on the scored line. Do not break the tablets with a tablet splitting device.

If you are unable to swallow the tablets, you may dissolve them in water. Add one-half teaspoon (2.5 ml) of water into a spoon. Place the prescribed number of tablets (or portions of tablets) onto the spoon with water. Wait 30 seconds to allow the tablets to disintegrate in the spoon. Take the mixture immediately with food.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking nifurtimox,

• tell your doctor and pharmacist if you are allergic to nifurtimox, any other medications, or any of the ingredients in nifurtimox tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you drink alcoholic beverages or take products containing alcohol. Your doctor will probably tell you not to take drink alcoholic beverages or take products containing alcohol while taking this medication.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever had a brain injury, a seizure, or a mental health disorder or serious changes in behavior. Also tell your doctor if you have or have ever had porphyria (an inherited blood disease that may cause skin or nervous system problems) or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, can possibly become pregnant, or father a child. Females who can become pregnant must take a pregnancy test before starting this medication. You should use birth control to prevent pregnancy during your treatment and for 6 months after your final dose. Males with female partners who can possibly become pregnant should use condoms during treatment and for 3 months after your final dose. If you become pregnant while taking nifurtimox, call your doctor. Nifurtimox can cause fetal harm.
• tell your doctor if you are breastfeeding. If you take nifurtimox while you are breastfeeding, your baby may receive some nifurtimox in breast milk. Watch your baby closely for vomiting, rash, a loss of appetite, fever, or irritability. Call the doctor if your baby has any of these symptoms.
• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking nifurtimox.
• you should know that nifurtimox may cause muscle weakness or tremors. Do not drive a car, bicycle, or operate machinery until you know how this medication affects you.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it with food. However, if it is within 3 hours of the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Nifurtimox may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vomiting
• stomach pain
• loss of appetite
• weight loss
• nausea
• diarrhea
• headache
• dizziness
• fever
• pale skin or shortness of breath

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash, hives, itching, swelling of the throat and face, or shortness of breath

Nifurtimox may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (small packet that contains a substance that absorbs moisture to keep the medication dry).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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