Change in Krintafel (tafenoquine) Label

If used for the radical cure of P. vivax malaria, Krintafel (tafenoquine) should be co-administered with chloroquine only. This is a change from the original Krintafel labeling that allowed for use of Krintafel in combination with other antimalarials (artemether-lumefantrine, atovaquone-proguanil, quinine plus doxycycline). CDC continues to recommend off-label use of Krintafel for radical cure of P. ovale, and like the new recommendations for P. vivax, Krintafel should be co-administered with chloroquine only. In a recent unpublished clinical trial, limited efficacy has been observed in patients with P. vivax malaria receiving Krintafel in combination with a certain artemisinin-based combination drug. A Dear Health Care Provider letter with additional information has been released by GSK, the manufacturer of Krintafel. For questions or additional information, contact the GSK Medical Information Department at 1-877-356-8368. Proposed changes to the label are under review by the U.S. Food and Drug Administration (FDA).

Page last reviewed: February 24, 2020