FDA approves tafenoquine to prevent malaria relapse

FDA approves tafenoquine to prevent malaria relapse

  • 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.

(RS)-Tafenoquin Structural Formula V1.svg

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.

Key points

  • Tafenoquine targets dormant liver forms of 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.

https://www.univadis.co.uk/

 

July 24, 2018 / Pharma News