Pronunciation:

ta-FEN-oh-kwin

Brand Names:

• Arakoda
• Krintafel

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antimalarial

Chemical—

Aminoquinoline

Uses of This Medicine:

Tafenoquine is used to prevent malaria. It is also used to prevent malaria from coming back after treatment (relapse) in patients who are receiving chloroquine treatment for acute malaria.

Tafenoquine belongs to a group of medicines, called antiprotozoals. It works by treating malaria, a red blood cell infection transmitted by the bite of a mosquito. It also prevents the development of the blood forms of the parasite, which are responsible for the relapse.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Arakoda™ in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Krintafel™ in children 16 years of age and older. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tafenoquine in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Dofetilide
• Metformin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown or
• Mental problems, history of—Should not be used in patients with these conditions.

• Nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficiency—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide or patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not break, crush, or chew it.

Take this medicine with food.

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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For preventing malaria:
    • Adults:
      • Before your trip (loading dose)—Two 100 milligrams (mg) tablets taken together once daily for 3 days.
      • While you are in the malaria area (maintenance dose)—Two 100 milligrams (mg) tablets taken together once a week, 7 days after the last loading dose.
      • After your trip—Two 100 milligrams (mg) tablets taken together, 7 days after the last maintenance dose.
    • Children—Use and dose must be determined by your doctor.
  • For preventing malaria relapse:
    • Adults and children 16 years of age and older—300 milligrams (mg) taken as a single dose (two 150-mg tablets taken together). This medicine must be taken on the first or second day of your malaria treatment (eg, chloroquine).
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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 to keep from getting pregnant during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Before taking this medicine, you and your child should be tested for G6PD deficiency or favism (blood disorder). Tafenoquine may cause hemolytic anemia in patients with these conditions. Talk to your doctor if you have concerns about this.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause a serious allergic reaction, including angioedema, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in or will be traveling to an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

• If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.
• Remain in air-conditioned or well-screened rooms to reduce contact with mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply insect repellant, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• If possible, sleep in a screened or air-conditioned room or under mosquito netting, preferably coated or soaked with pyrethrum, to avoid being bitten by malaria-carrying mosquitoes.
• Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

Do not use Krintafel™ with medicines to treat malaria other than chloroquine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bluish-colored lips, fingernails, or palms

dark urine

difficulty breathing

dizziness or lightheadedness

fever

headache

pale skin

rapid heartbeat

sore throat

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Abnormal dreams

anxiety

discouragement

feeling sad or empty

hives or welts, itching, skin rash

irritability

lack of appetite

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss of interest or pleasure

redness of the skin

sleepiness or unusual drowsiness

trouble concentrating

trouble sleeping

Rare

Agitation

back, leg, or stomach pains

black, tarry stools

bleeding gums

blood in the urine or stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chills

clay-colored stools

diarrhea

fainting

fast heartbeat

general body swelling

hoarseness

increased sensitivity to pain

increased sensitivity to touch

irritation

joint pain, stiffness, or swelling

nausea

nosebleed

pinpoint red spots on the skin

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

tremor

trouble with swallowing

trouble breathing

unpleasant breath odor

vomiting

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Blurred vision or any other change in vision

eye redness, irritation, or pain

Less common

Motion sickness

Rare

Change in color vision

decreased vision

difficulty seeing at night

increased sense of hearing

increased sensitivity of the eyes to sunlight

loss of memory

night blindness

poor coordination

problems with memory

seeing floating dark spots or material before the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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