The Food and Drug Administration (FDA) has approved Krintafel (tafenoquine; GlaxoSmithKline) for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients ≥16 years old who are receiving appropriate antimalarial therapy for acute P. vivax infection, making it the first single-dose therapy for this indication.
The approval was based on data from 3 randomized, double-blind studies, DETECTIVE Part 1 and Part 2 and GATHER. In the DETECTIVE study, single-dose tafenoquine 300mg coadministered with chloroquine was found to be more effective than chloroquine alone for preventing P. vivax malaria relapse. The GATHER study, which investigated the effect of a single-dose of tafenoquine 300mg on hemoglobin levels compared with primaquine, showed that the incidence of decline in hemoglobin (the primary endpoint) was very low and similar between the 2 treatment groups.
Tafenoquine, an 8-aminoquinoline antimalarial, is active against the liver stages including the hypnozoite (dormant stage) of P. vivax. It is active against pre-erythrocytic (liver) and erythrocytic (asexual) forms as well as gametocytes of P. vivax. The activity of tafenoquine against the pre-erythrocytic liver stages of the parasite prevents the development of the erythrocytic forms of the parasite, which are responsible for relapses in P. vivax malaria.
Krintafel is not indicated for the treatment of acute P. vivax malaria. Before prescribing, patients must be tested for glucose-6 phosphate dehydrogenase (G6PD) deficiency due to the risk of hemolytic anemia. In addition, pregnancy testing is recommended for females of reproductive potential before initiating treatment.
Krintafel is supplied as a 150mg tablet.
For more information visit GlaxoSmithKline.com.