What is the most important information I should know about tafenoquine?
You should not use this medicine 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.
What is tafenoquine?
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.
What should I discuss with my healthcare provider before taking tafenoquine?
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.
How should I take tafenoquine?
Before you take this medicine, 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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking tafenoquine?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of tafenoquine?
Get emergency medical help if you have signs of an allergic reaction: hives; dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.
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 may include:
- nausea, vomiting;
- abnormal hemoglobin tests;
- dizziness; or
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.
What other drugs will affect tafenoquine?
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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