Arakoda (tafenoquine) Antimalarial Medication to Prevent Malaria

What is Arakoda, and how does it work?

• Arakoda is a prescription medicine used to help prevent malaria in people 18 years of age and older.
• Malaria is a serious disease of the blood that is spread by infected mosquitos.
• It is not known if
  Arakoda is safe and effective in children.

What are the side effects of Arakoda?

Arakoda may cause serious side effects, including:

• Allergic (hypersensitivity) reactions. Allergic reactions can happen after you take
  Arakoda. Signs and symptoms of an allergic reaction may not happen right away (delayed reaction). Get medical help right away if you have any signs or symptoms of an allergic reaction including:
  • swelling of the face, lips, tongue or throat
  • itching
  • trouble breathing or wheezing
  • vomiting
  • fainting and feeling lightheaded
  • rash
  • hives

The most common side effects of
Arakoda include:

• diarrhea,
• headache,
• back pain,
• nausea,
• vomiting,
• dizziness,
• increased liver enzyme levels in your blood,
• motion sickness,
• insomnia,
• depression,
• abnormal dreams and
• anxiety.

Other side effects of Arakoda include eye problems. Some people who take
Arakoda can have a problem with the cornea of the eye called vortex keratopathy. This problem can be seen during an eye exam. Vortex keratopathy does not cause vision problems and will usually go away after you stop taking
Arakoda.

These are not all the possible side effects of Arakoda.

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

What is the dosage for Arakoda?

Tests To Be Performed Prior To Arakoda Dose Initiation

• All patients
  must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to
  prescribing Arakoda.
• Pregnancy testing is recommended for females of
  reproductive potential prior to initiating treatment with Arakoda.

Recommended Dosage And Administration Instructions

The recommended dosage of
Arakoda is described in Table 1 below. Arakoda can be administered for up to 6 months of continuous dosing.

Table 1: Recommended Dosage of
Arakoda in Patients (18 Years of Age and Older)

Regimen NameTimingDosageLoading regimenFor each of the 3 days before travel to a malarious area200 mg (2 of the 100 mg tablets) once daily for 3 daysMaintenance regimenWhile in the malarious area200 mg (2 of the 100 mg tablets) once weekly – start 7 days after the last loading regimen doseTerminal prophylaxis regimenIn the week following exit from the malarious area200 mg (2 of the 100 mg tablets) taken one time, 7 days after the last maintenance dose

• Administer
  Arakoda with food.
• Swallow the tablet whole. Do not break, crush or chew the tablets.
• Complete the full course of
  Arakoda including the loading dose and the terminal dose.

Table 2: How to Replace Missed Doses of Arakoda

Dose(s) MissedHow to Replace Missed Dose(s):1 Loading dose1 dose of 200 mg (2 of the 100 mg tablets) so that a total of 3 daily loading doses have been taken. Begin maintenance dose 1 week after the last loading dose.2 Loading doses2 doses of 200 mg (2 of the 100 mg tablets) on 2 consecutive days so that a total of 3 daily loading doses have been taken. Begin maintenance dose 1 week after the last loading dose.1 Maintenance (weekly) dose1 dose of 200 mg (2 of the 100 mg tablets) on any day up to the time of the next scheduled weekly dose.2 Maintenance (weekly) doses1 dose of 200 mg (2 of the 100 mg tablets) on any day up to the time of the next scheduled weekly dose.3 or more Maintenance (weekly) doses2 doses of 200 mg (2 of the 100 mg tablets), taken as 200 mg (2 of the 100 mg tablets) once daily for 2 days up to the time of the next weekly dose.Terminal prophylaxis dose1 dose of 200 mg (2 of the 100 mg tablets) as soon as remembered.

QUESTION

Bowel regularity means a bowel movement every day.
See Answer

What drugs interact with Arakoda?

Effect Of Arakoda On Organic Cation Transporter-2 (OCT2) And Multidrug And Toxin Extrusion (MATE) Substrates

• The effect of coadministration of tafenoquine on the pharmacokinetics of OCT2
  and MATE substrates in humans is unknown.
• However, in vitro observations suggest
  the potential for increased concentrations of these substrates which may increase the risk of toxicity of these drugs.
• Avoid coadministration of Arakoda with OCT2 and MATE substrates (e.g., dofetilide, metformin).
• If coadministration cannot be avoided, monitor for drug-related toxicities and consider dosage reduction if needed based on approved product labeling of the coadministered drug.

Is Arakoda safe to use while pregnant or breastfeeding?

• There is a potential risk of Arakoda to a fetus. Women should inform their healthcare provider of a known or suspected pregnancy.
• Females should use effective contraception during treatment with Arakoda and for 3 months after the final dose.
• Women with a G6PD-deficient infant, or if they do not know the G6PD status of their infant, not to breastfeed during treatment with
  Arakoda and for 3 months after the final dose