Arakoda Approval History
Reviewed on Aug 14, 2018 by J.Stewart B.Pharm
Arakoda (tafenoquine) is an 8-aminoquinoline antimalarial drug indicated for the prophylaxis of malaria in patients aged 18 years and older.
Dosage and Administration
- Loading regimen: (for each of the 3
days before travel to a malarious area)
- 200 mg (2 of the 100 mg tablets) once daily for 3 days
- Maintenance regimen: (while in the malarious area)
- 200 mg (2 of the 100 mg tablets) once weekly – start 7 days after the last loading regimen dose
- Terminal prophylaxis regimen: (in the week following exit from the malarious area)
- 200 mg (2 of the 100 mg tablets) one-time 7 days after the last maintenance dose
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.
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
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.
Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters.
Use in Specific Populations
Pregnancy: Arakoda is not recommended for use in pregnant women. Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the final dose. A pregnancy test should be taken to confirm pregnancy status prior to initiating treatment.
Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the final dose.
Development History and FDA Approval Process for Arakoda
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