Arakoda 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.

Arakoda is used to prevent malaria caused by the Plasmodium vivax parasite.

Arakoda is for use in adults and children at least 16 years old who are also using another medicine called chloroquine.

Arakoda is for use in people 18 years of age and older. It is not known if Arakoda is safe and effective in children.

You should not use Arakoda 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.

Do not take Arakoda if you have a history of psychotic disorders, or you currently have psychotic symptoms including hallucinations (seeing or hearing things that are not really there), delusions (false or strange thoughts or beliefs), or disorganized thinking or behavior.

Before you take Arakoda, 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 Arakoda is 2 tablets taken at one time. Start taking Arakoda 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 Arakoda, 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 Arakoda tablets 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.

Usual Adult Dose of Arakoda for Malaria:

300 mg orally once as a single dose.

Usual Adult Dose for Malaria Prophylaxis:

Loading dose: 200 mg orally once a day for 3 days
Maintenance dose: 200 mg orally once a week
Terminal prophylaxis dose: 200 mg orally once as a single dose

Duration of therapy: Up to 6 months of continuous dosing

Comments:
-The loading dose should be administered for each of the 3 days prior to travel to malarious area.
-The maintenance dose should be started 7 days after the last loading dose and should be continued while in the malarious area.
-The terminal prophylaxis regimen should be administered 7 days after the last maintenance dose in the week after exit from malarious area.
-The full course of therapy should be completed (including the loading dose, maintenance dose, and terminal dose).
-To replace missed dose(s):
---If 1 loading dose is missed: 1 dose of 200 mg so that a total of 3 daily loading doses have been administered; the maintenance dose should be started 1 week after the last loading dose
---If 2 loading doses are missed: 2 doses of 200 mg on 2 consecutive days so that a total of 3 daily loading doses have been administered; the maintenance dose should be started 1 week after the last loading dose
---If 1 maintenance (weekly) dose is missed: 1 dose of 200 mg on any day up to the time of the next scheduled weekly dose
---If 2 maintenance (weekly) doses are missed: 1 dose of 200 mg on any day up to the time of the next scheduled weekly dose
---If at least 3 maintenance (weekly) doses are missed: 2 doses of 200 mg, administered as 200 mg once a day for 2 days up to the time of the next scheduled weekly dose
---If the terminal prophylaxis dose is missed: 1 dose of 200 mg as soon as remembered.

Usual Pediatric Dose of Arakoda for Malaria:

16 years or older: 300 mg orally once as a single dose

Comments:
-This drug is not indicated for the treatment of acute P vivax malaria.
-This drug should be coadministered on the first or second day of appropriate antimalarial therapy for acute P vivax malaria (e.g., chloroquine).
-A repeat dose is recommended if vomiting occurs within 1 hour after dosing; re-dosing should not be attempted more than once.

Use: For the radical cure (prevention of relapse) of P vivax malaria in patients receiving appropriate antimalarial therapy for acute P vivax infection

To make sure Arakoda is safe for you, tell your doctor if:

• you have a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency; or

• you are allergic to Arakoda 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 Arakoda.

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 Arakoda, 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.

Arakoda is not approved for use by anyone younger than 16 years old.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Arakoda: 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 Arakoda side effects may include:

• nausea, vomiting;

• abnormal hemoglobin tests;

• dizziness; or

• headache.

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.

Other drugs may interact with 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.