Tafenoquine

Tafenoquine (Krintafel) is used to prevent the return of malaria (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death) in people 16 years of age and older who are infected and are currently receiving chloroquine or hydroxychloroquine to treat malaria. Tafenoquine (Arakoda) is used alone to prevent malaria in travelers who visit areas where malaria is common. Tafenoquine is in a class of medications called antimalarials. It works by killing the organisms that cause malaria.

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 (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

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

Before taking tafenoquine,

• tell your doctor and pharmacist if you are allergic to tafenoquine, primaquine, any other medications, or any of the ingredients in tafenoquine tablets.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking tafenoquine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have glucose-6-phosphate dehydrogenase (G-6-PD) deficiency (an inherited blood disease). Your doctor will probably tell you not to take tafenoquine. Also tell your doctor if you have or have ever had mental health problems. Your doctor may tell you not to take tafenoquine.
• tell your doctor if you have or have ever had hemolytic anemia (a condition with an abnormally low number of red blood cells), methemoglobinemia (a condition with defective red blood cells that are unable to carry oxygen to the tissues in the body), nicotinamide adenine dinucleotide (NADH) deficiency (a genetic condition), or kidney or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. If you are a woman of childbearing age, you will have to take a pregnancy test before starting treatment. You should use birth control to prevent pregnancy during your treatment with tafenoquine and for 3 months after your final dose. Talk to your doctor about methods of birth control that will work for you. If you become pregnant while taking tafenoquine, call your doctor immediately. Tafenoquine may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed.

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

Call your doctor or pharmacist to ask what to do if you miss a dose of tafenoquine (Arakoda).

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

• nausea
• vomiting
• diarrhea
• difficulty falling asleep or staying asleep
• anxiety
• changes in mood
• unusual dreams
• headache
• vision problems, including blurred vision or sensitivity to light

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

• rash
• hives
• swelling of the eyes, face, lips, tongue, mouth, or throat
• difficulty breathing or swallowing
• shortness of breath
• hoarseness or throat tightness
• dark colored urine
• grey-bluish color of lips and/or skin
• dizziness
• confusion
• hallucinations (seeing things or hearing voices that do not exist)
• delusions (having strange thoughts or beliefs that have no basis in reality) such as thoughts that people are trying to harm you even if they are not
• lightheadedness
• yellowing of the skin or eyes

Tafenoquine 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).

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 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.

• Arakoda^®
• Krintafel^®