Tafenoquine is an anti-malaria medicine that interferes with the growth of parasites in the human body. Parasites that cause malaria can enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Tafenoquine is used to prevent malaria caused by the Plasmodium vivax parasite.

Tafenoquine is for use in adults and children at least 16 years old who are also using another medicine called chloroquine.

Tafenoquine may also be used for purposes not listed in this medication guide.

You should not use tafenoquine if you have a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency. Your doctor will perform a test to make sure you do not have this condition.

Tafenoquine comes as tablets to take by mouth with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tafenoquine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you are taking tafenoquine (Krintafel) to prevent malaria from coming back, it is usually taken as a single dose (2 tablets) on the first or second day of your treatment with chloroquine or hydroxychloroquine.

If you are taking tafenoquine (Arakoda) for the prevention of malaria, one dose (2 tablets) is usually taken once a day for 3 days, starting 3 days before traveling to an area where there is malaria. While you are in the area, one dose (2 tablets) is usually taken once a week on the same day of the week. After you return from the area, one dose (2 tablets) is usually taken 7 days after the last dose that was taken before your return. You should not take tafenoquine (Arakoda) for the prevention of malaria for more than 6 months.

Swallow the tablets whole; do not split, chew, or crush them.

If you vomit within an hour after taking tafenoquine (Krintafel), call your doctor. You may need to take another dose of this medication.

Take tafenoquine until you finish the prescription, even if you feel better. If you stop taking tafenoquine too soon or skip doses, your infection may not be completely treated or you may not be protected from future infections.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient if you are taking Tafenoquine (Krintafel). If you are taking tafenoquine (Arakoda), your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Before you take tafenoquine, your doctor will perform a test to make sure you do not have G6PD deficiency.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

The usual dose of tafenoquine is 2 tablets taken at one time. Start taking tafenoquine on the first or second day you start taking chloroquine.

Take with food.

Swallow the tablets whole and do not crush, chew, or break them.

If you vomit within 1 hour after taking tafenoquine, you may need to take a second dose. Call your doctor for instructions.

Call your doctor as soon as possible if you have been exposed to malaria, or if you have fever, vomiting, or diarrhea during or after a stay in an area where malaria is common.

Use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

No medication is 100% effective in treating or preventing all types of malaria. For best results, keep using the medication as directed.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

You should not use tafenoquine if:

• you have a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency; or

• you are allergic to tafenoquine or similar medicines (such as primaquine).

Do not breastfeed while using tafenoquine if your baby has G6PD deficiency (or has not been tested for it). If the baby does have G6PD deficiency, you should also not breastfeed for at least 3 months after your last dose of tafenoquine.

Tafenoquine may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while taking tafenoquine, and for at least 3 months after your last dose.

Tell your doctor right away if you become pregnant.

Tell your doctor if you have ever had:

• a mental illness; or

• liver or kidney disease.

Tafenoquine is not approved for use by anyone younger than 16 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.

Tafenoquine may cause serious side effects. Call your doctor at once if you have:

• pale or yellowed skin, dark colored urine;

• darkening of your mouth, lips, or fingernails;

• fast heartbeats, shortness of breath;

• a headache, or light-headed feeling (like you might pass out);

• confusion, tiredness; or

• new or worsening mental health problems--anxiety, strange dreams, trouble sleeping.

Common side effects of tafenoquine may include:

• nausea, vomiting;

• abnormal hemoglobin tests;

• dizziness; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect tafenoquine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to tafenoquine.

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.