Uses of Tafenoquine:

• It is used to prevent malaria from coming back.

What do I need to tell my doctor BEFORE I take Tafenoquine?

• If you are allergic to tafenoquine (prevention of malaria relapse); any part of tafenoquine (prevention of malaria relapse); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have glucose-6-phosphate dehydrogenase (G6PD) deficiency or you have not been tested for it.
• If you have ever had any mental health or behavior problems.
• If you are taking any of these drugs: Dofetilide or metformin.
• If you are pregnant or may be pregnant. Do not take tafenoquine (prevention of malaria relapse) if you are pregnant.
• If you are breast-feeding and your child has G6PD deficiency or your child has not been tested for it. Do not breast-feed for 3 months after taking tafenoquine (prevention of malaria relapse) if your child has G6PD deficiency or has not been tested for it.

This is not a list of all drugs or health problems that interact with tafenoquine (prevention of malaria relapse).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tafenoquine (prevention of malaria relapse) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tafenoquine?

• Tell all of your health care providers that you take tafenoquine (prevention of malaria relapse). This includes your doctors, nurses, pharmacists, and dentists.
• People with an enzyme deficiency called G6PD deficiency may have more chance of getting hemolysis. Do not take tafenoquine (prevention of malaria relapse) if you have G6PD deficiency. You may need to be screened for G6PD deficiency before taking tafenoquine (prevention of malaria relapse). Talk with your doctor.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start tafenoquine (prevention of malaria relapse) to show that you are NOT pregnant.
• Women must use birth control while taking tafenoquine (prevention of malaria relapse) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Tafenoquine) best taken?

Use tafenoquine (prevention of malaria relapse) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take tafenoquine (prevention of malaria relapse) with food.
• Swallow whole. Do not chew, break, or crush.
• If you throw up within 1 hour of taking tafenoquine (prevention of malaria relapse), call your doctor to find out what to do.

What do I do if I miss a dose?

• Most of the time, 1 dose of tafenoquine (prevention of malaria relapse) is needed. If you miss the dose, take it as soon as you think about it with food. If you need to take more than 1 dose of tafenoquine (prevention of malaria relapse), follow what your doctor has told you to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of hemolytic anemia like dark lips or urine, dizziness or passing out, feeling confused, feeling very tired or weak, pale skin, shortness of breath, or yellow skin or eyes.
• Signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath. This effect is rare but may be deadly if it happens.
• Mental, mood, or behavior changes that are new or worse.
• Strange or odd dreams.
• Trouble sleeping.
• Hallucinations (seeing or hearing things that are not there).
• Feeling confused.
• Very bad dizziness or passing out.

What are some other side effects of Tafenoquine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tafenoquine?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about tafenoquine (prevention of malaria relapse), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• What is the difference between Arakoda and Krintafel?
• How do you take Arakoda for the prevention of malaria?
• How do you take Krintafel?