Uses

Tafenoquine is used in combination with another medication (chloroquine) to prevent the return of malaria. Malaria is caused by infection with a parasite spread by mosquito bite. After they multiply and grow, the parasites infect your red blood cells and cause symptoms of malaria (such as fever, chills, sweating, headache, other flu-like symptoms). This medication works by stopping the growth of the parasite that causes malaria.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start taking tafenoquine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food as directed by your doctor, usually a one-time dose taken on the first or second day of treatment with other antimalarial medication (chloroquine). The manufacturer directs to swallow this medication whole, and to not break, crush, or chew the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split, crushed, or chewed. Follow your doctor's directions on how to take this medication.

If you vomit within 1 hour after taking your dose, ask your doctor if you should take another dose.

No medication is completely effective in preventing the return of malaria. Malaria treatment works best when it is started early. Tell your doctor if your symptoms do not get better or if they get worse.

Side Effects

Tafenoquine stays in your body a long time, so side effects may be delayed or last longer than expected.

Trouble sleeping, anxiety, or nightmares may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• eye/vision problems

Get medical help right away if you have any very serious side effects, including:

• mental/mood changes (such as hallucinations, unusual thoughts/behavior, confusion)
• unusual tiredness
• rapid breathing
• pale skin
• shortness of breath
• fast heartbeat
• dizziness/lightheadedness
• bluish lips or skin
• headache that lasts or is severe
• yellowing eyes/skin
• dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking tafenoquine, tell your doctor or pharmacist if you are allergic to it; or to chloroquine or primaquine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• mental/mood disorders (such as psychosis, schizophrenia, hallucinations, delusions, disorganized thinking/behavior)
• certain enzyme deficiencies (G6PD deficiency, NADH-dependent methemoglobin reductase deficiency)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. Women of childbearing age should have a pregnancy test before taking this medication. You should not become pregnant while using tafenoquine. Tafenoquine may harm an unborn baby. Ask about reliable forms of birth control for 3 months after the dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. A blood test to check if your baby has G6PD deficiency should be done before you start breast-feeding. If your baby is G6PD deficient or if the G6PD status is unknown, breast-feeding is not recommended for 3 months after the dose. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication can slow down the removal of other medications from your body, which may affect how they work. One example is dofetilide, among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as G6PD deficiency) should be done before you take this medication. Women of childbearing age should also have a pregnancy test before taking this medication. Keep all medical and lab appointments.

Missed Dose

Not applicable.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.