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 (Arakoda)
  2. Radical cure1 of Plasmodium vivax malaria (Krintafel)

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 individuals with G6PD deficiency or unknown G6PD status is contraindicated.

The long terminal half-life of tafenoquine (approximately 16 days) offers potential advantages of 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 areas. 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) once weekly during travel (starting 1 week after the last pretravel dose)
  • 200 mg (2 tablets) once after travel (starting 1 week after the last travel dose)

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 of P. vivax in patients ≥16 years. If used, Krintafel should only be used in patients who are receiving chloroquine against acute P. vivax infection; it cannot be used with other antimalarials. Krintafel is manufactured by GlaxoSmithKline, Research Triangle Park, NC.

Recommended dosing of Krintafel:

  • 300 mg (2 tablets), single dose, 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 antirelapse therapy, radical cure eliminates dormant P. vivax and P. ovale liver-stage parasites (hypnozoites).

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