Tafenoquine

KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection. Limitations of Use • KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. • Concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria. KRINTAFEL is an antimalarial indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection. Limitations of Use • KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. • The concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria.

Tafenoquine is an 8-aminoquinoline antimalarial drug.

• All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing KRINTAFEL. • Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with KRINTAFEL. • The recommended dose of KRINTAFEL in patients aged 16 years and older is a single dose of 300 mg administered as two 150-mg KRINTAFEL tablets taken together. • Coadminister KRINTAFEL on the first or second day of chloroquine therapy for the acute P. vivax malaria. • Administer KRINTAFEL with food.

KRINTAFEL is contraindicated in: • Patients with G6PD deficiency or unknown G6PD status due to the risk of hemolytic anemia. • Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if the G6PD status of the infant is unknown. • Patients with known hypersensitivity to tafenoquine, other 8-aminoquinolines, or any component of KRINTAFEL. • G6PD deficiency or unknown G6PD status. • Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown. • Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of KRINTAFEL.

• Hemolytic Anemia: G6PD testing must be performed before prescribing KRINTAFEL due to the risk of hemolytic anemia. Monitor patients for clinical signs or symptoms of hemolysis. • G6PD Deficiency in Pregnancy or Lactation: KRINTAFEL may cause hemolytic anemia when administered to a pregnant woman with a G6PD-deficient fetus. KRINTAFEL is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to KRINTAFEL through breast milk. Check infant’s G6PD status before breastfeeding begins. • Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. • Psychiatric Effects: Serious psychiatric adverse reactions have been observed in patients with a previous history of psychiatric conditions at doses higher than the approved dose.

The following clinically significant adverse reactions have been observed with KRINTAFEL and are discussed in detail in the Warnings and Precautions section: • Hemolytic anemia • Methemoglobinemia • Psychiatric effects • Hypersensitivity reactions Common adverse reactions (≥5%) were dizziness, nausea, vomiting, headache, and decreased hemoglobin.

Avoid coadministration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters.

Storage Store at 20°C to 25°C (68°F to 77°F). Temperature excursions are permitted to 15°C to 30°C (59°F to 86°F). Store in the original package to protect from moisture.