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Clinical Update
Tafenoquine Approved for Malaria Prophylaxis and Treatment

The US Food and Drug Administration (FDA) has approved the drug tafenoquine for 2 indications:

  1. Prophylaxis of malaria
  2. Radical cure1 of Plasmodium vivax malaria

Tafenoquine is an 8-aminoquinoline antimalarial drug related to primaquine. As with primaquine, tafenoquine can cause severe hemolytic anemia in people with G6PD deficiency. Those with partial deficiency that may be missed by qualitative testing may also be at risk for hemolysis. Therefore, physicians must perform quantitative G6PD testing before prescribing tafenoquine. Tafenoquine use in people with G6PD deficiency or unknown G6PD status is contraindicated.

The long terminal half-life of tafenoquine (approximately 16 days) offers potential advantages in less frequent dosing for prophylaxis and a single-dose course for treatment.

Prophylaxis of Malaria

FDA approved the use of Arakoda (100 mg tafenoquine per tablet) for prophylaxis of malaria in patients ≥18 years of age. It can be used as prophylaxis against all Plasmodium spp. and in any malarious area. Arakoda is manufactured by 60 Degrees Pharmaceuticals, Washington, DC.

Recommended dosing of Arakoda:

  • 200 mg (2 tablets) daily for 3 days before travel
  • 200 mg (2 tablets) weekly during travel (starting 1 week after the last pretravel dose)
  • 200 mg (2 tablets) once 1 week after travel

Arakoda should not be used in:

  • People with G6PD deficiency or unknown G6PD status.
  • Pregnant women.
  • Women breastfeeding an infant with G6PD deficiency or unknown G6PD status.
  • People with a history of psychotic disorder or current psychotic symptoms (hallucinations, delusions, or grossly disorganized behavior).
  • People with known hypersensitivity to tafenoquine, other 8-aminoquinolines, or any component of Arakoda.

In clinical trials, the most common adverse events were headache, back pain, dizziness, nausea, and diarrhea. See the full prescribing information for additional details.

Radical Cure of P. vivax Malaria

FDA approved the use of Krintafel (150 mg tafenoquine per tablet) for radical cure in patients ≥16 years of age already receiving antimalarial therapy against acute P. vivax infection. Krintafel is manufactured by GlaxoSmithKline, Research Triangle Park, NC.

Krintafel is not indicated as a treatment for acute P. vivax infection, but it may be used off-label as presumptive antirelapse therapy (terminal prophylaxis) for travelers to areas with P. vivax or P. ovale malaria who take medication other than tafenoquine or primaquine as primary prophylaxis.

Recommended dosing of Krintafel:

  • 300 mg (2 tablets), ideally overlapping with therapy for acute P. vivax infection.

Krintafel should not be used in:

  • People with G6PD deficiency or unknown G6PD status.
  • Pregnant women.
  • Women breastfeeding an infant with G6PD deficiency or unknown G6PD status.
  • People with known hypersensitivity to tafenoquine, other 8-aminoquinolines, or any component of Krintafel.

In clinical trials, the most common adverse events in patients receiving Krintafel plus chloroquine were dizziness, nausea, vomiting, decreased hemoglobin, and headache. Those with a history of psychiatric illness may be at higher risk for psychiatric adverse events.

See the full prescribing information for additional details.

Additional Information

1Also referred to as radical treatment, radical cure eliminates dormant P. vivax and P. ovale liver-stage parasites (hypnozoites).

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