What is Arakoda?
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.
Warnings
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 taking this medicine
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.
How to use Arakoda
Read the Medication Guide provided by 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. 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.
Take this medication starting 3 days before you travel to an area with malaria, usually once daily for 3 days. While you are in the malarious area, take this medication usually once each week, starting 7 days after the last daily dose you took. After you leave the malarious area, take the last dose of this medication 7 days after the last dose you took while you were in the malarious area.
For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day when you take it daily, and on the same day of the week when you take it weekly.
It is important that you do not miss any doses. See the Missed Dose section for more information.
Continue to take this medication until the full prescribed amount is finished. Stopping the medication too early may result in loss of protection against getting malaria.
No medication is completely effective in preventing malaria. Get medical help right away if you develop symptoms of malaria (such as fever, chills, headache, other flu-like symptoms). Malaria is best treated when treatment is started early.
How Should I Take Arakoda?
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.
Dosing information
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
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Follow your doctor’s instructions about any restrictions on food, beverages, or activity.
Arakoda side effects
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.
Important Safety Information by 60 Degrees Pharmaceuticals
60° Pharmaceuticals (60P) was founded with the goal of developing medicines for tropical diseases, including those considered neglected by the World Health Organization. In 2018, we took a huge step toward meeting our goals when our first product was approved for use by the US Food and Drug Administration.
ARAKODA® (tafenoquine) is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.
Contraindications
ARAKODA® should not be administered to:
- G6PD deficiency or unknown G6PD status
- Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown
- Patients with a history of psychotic disorders or current psychotic symptoms
- Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®
Warnings and Precautions
- Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.
- G6PD Deficiency in Pregnancy or Lactation: ARAKODA® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA® through breast milk. Check infant’s G6PD status before breastfeeding begins.
- Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.
- Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA® therapy and, evaluation by a mental health professional as soon as possible.
- Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA®. If hypersensitivity reactions occur, institute appropriate therapy.
- Delayed Adverse Reactions: Due to the long half-life of ARAKODA® (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.
Adverse Reactions
The most common adverse reactions (incidence ≥1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams and anxiety.
Drug Interactions
Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters.