- FDA has issued Priority Review marketing approval single-dose tafenoquine (Krintafel) for relapse prevention of Plasmodium vivax malaria in patients aged >16 years receiving appropriate antimalarial therapy.
- Approval was based on 33 studies in >4000 participants.
Why this matters
- Tafenoquine is an 8-aminoquinoline derivative with activity against all lifestyle stages of P vivax.
- Patients traveling extensively or residing in South- and South-East Asia, Latin America, and/or horn of Africa may be appropriate candidates for tafenoquine.
- Tafenoquine targets dormant liver forms of P vivax; required coadministration with available antimalarials (chloroquine, artemisinin-based combination therapies) is known as ‘radical cure.’
- Tafenoquine is administered as a single dose of 300 mg (2 150-mg tablets) taken together, on day 1or 2 of concurrent antimalarial treatment for acute infections.
- All patients should be first tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency before receiving tafenoquine; patients with known G6PD deficiencies are not candidates for tafenoquine.
- Use during pregnancy may cause hemolytic anemia in G6PD-deficient fetuses; females of reproductive age should avoid pregnancy or use effective contraception 3 months after taking tafenoquine.
- Coadministration with organic cation transporter-2 substrates, multidrug and toxin transporters is contraindicated.
- Tafenoquine prescribing information is available here.