Tafenoquine

Tafenoquine is a medicine used to prevent malaria by stopping the growth of parasites in the body. These parasites can enter through a mosquito bite. Malaria is often found in places like Africa, South America, and Southern Asia.

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

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

Tafenoquine may also be used for other reasons not mentioned in this medication guide.

Before you take tafenoquine, your doctor will do a test to check if you have G6PD deficiency.

Follow all instructions 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 once. Start taking tafenoquine on the first or second day you begin 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 develop fever, vomiting, or diarrhea during or after being in an area where malaria is common.

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

No medication is 100% effective in treating or preventing all types of malaria. For best results, continue 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. Your doctor will perform a test to ensure you do not have this condition.

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.

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

Tafenoquine may cause serious side effects. Call your doctor right away 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 feel light-headed (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 the FDA at 1-800-FDA-1088.

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

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

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

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 begin or stop using.

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