Tafenoquine (ta-FEN-oh-kwin)

Prevents malaria. Also prevents malaria from coming back after treatment (relapse).

Brand Name(s):

Arakoda, Krintafel

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole. Do not break, crush, or chew it.
• It is best to take this medicine with food or milk.
• Malaria prevention while traveling: You may need to start using Arakoda™ 3 days before you start your trip. You may also need to keep using this medicine for up to 6 months after you get home. Ask your doctor about your schedule.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
  • Arakoda™:
    • If you miss 1 or 2 daily doses of this medicine before your trip:
      • 1 daily dose: Take the missed dose (2 tablets) then go back to your regular dosing schedule until you have taken a total of 3 daily doses. Start taking your weekly doses 1 week after your last daily dose.
      • 2 daily doses: Take the missed dose (2 tablets), once a day for 2 days in a row for a total of 3 daily doses. Start taking your weekly doses 1 week after your last daily dose.
    • If you miss any weekly doses while you are in the malaria area:
      • 1 weekly dose: Take 2 tablets, 1 time on any day up to the time of your next scheduled weekly dose.
      • 2 weekly doses: Take 2 tablets, 1 time on any day before your next scheduled weekly dose.
      • 3 or more weekly doses: Take 2 tablets, once a day for 2 days up to the time of your next scheduled weekly dose.
    • If you miss taking your last dose of this medicine, 7 days after the last dose that you took while in the malaria area, take the missed dose as soon as you can.
  • Krintafel™: If you vomit within 1 hour after taking a dose of this medicine, you may take a second dose. Do not take more than 2 doses of this medicine.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use Krintafel™ with medicines to treat malaria other than chloroquine.
• Some medicines can affect how tafenoquine works. Tell your doctor if you are using dofetilide or metformin.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for 3 months after the last dose.
• If your baby has G6PD deficiency or an unknown G6PD status, do not breastfeed during treatment with this medicine and for 3 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or a history of mental problems.
• This medicine may cause the following problems:
  • Blood problems (including hemolysis, methemoglobin), which may be life-threatening
  • Changes in mood or behavior
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bluish-colored lips, fingernails, or palms, dark urine
• Trouble breathing, uneven heartbeat, yellow skin or eyes
• Unusual bleeding, bruising, or weakness
• Unusual mood or behavior

If you notice these less serious side effects, talk with your doctor:

• Dizziness
• Nausea, vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088