Tafenoquine Tablets

What is this medication?

TAFENOQUINE (ta FEN oh kwin) prevents malaria. It works by killing the parasite that causes malaria. It will not treat colds, the flu, or infections caused by bacteria or viruses.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Arakoda, KRINTAFEL

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• G6PD deficiency
• Hepatic disease
• Kidney disease
• Mental health conditions
• An unusual or allergic reaction to tafenoquine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it with food. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 16 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose.

What may interact with this medication?

Do not take this medication with any of the following:

• Dofetilide

This medication may also interact with the following:

• Metformin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work while you are taking this medication.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 3 months after stopping therapy. Contraception is recommended while taking this medication and for 3 months after stopping therapy. Talk to your care team about reliable forms of contraception.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Headache, unusual weakness or fatigue, shortness of breath, nausea, vomiting, rapid heartbeat, blue skin or lips, which may be signs of methemoglobinemia
• Hemolytic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, dark urine, yellowing skin or eyes
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Headache
• Nausea
• Trouble sleeping
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medications to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.