ARAKODA

Absorption A food effect study was not conducted with the 100 mg ARAKODA tablet. In majority of the clinical trials, tafenoquine was administered under fed conditions. Table 5 provides the pharmacokinetics of tafenoquine following single dose administration of 200 mg ARAKODA (two 100-mg ARAKODA tablets) in 65 healthy adult subjects under fed conditions. In this study, ARAKODA was administered with a high-calorie, high-fat meal (approximately 1000 calories with 19% protein, 31% carbohydrate, and ...

Clinical Trials 1, 2, and 3 Three double-blind, randomized, controlled studies have been performed to evaluate the efficacy of ARAKODA.

Trial 1(NCT #02491606) was a Phase IIb, placebo-controlled study conducted in Kenya, an area of holoendemic P. falciparum malaria. After taking a three-day presumptive course of halofantrine to eliminate any existing parasitemia, subjects were randomized into one of four groups (placebo and three different ARAKODA dosing groups; one group received 200 mg once daily for 3 days, then a maintenance regimen of weekly dose of 200 mg for 10-15 weeks). Sixty-one per...

The following clinically significant adverse reactions observed with ARAKODA are discussed in detail in the Warnings and Precautions section:

• Hemolytic Anemia [see Warnings and Precautions ( 5.2 )]
• Methemoglobinemia [see Warnings and Precautions ( 5.3 )]
• Psychiatric Effects [see Warnings and Precautions ( 5.4 )]
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (incidence ≥1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiti...

ARAKODA is contraindicated in:

• patients with G6PD deficiency or unknown G6PD status due to the risk of hemolytic anemia [see Warnings and Precautions ( 5.2 )] .
• breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if the G6PD status of the infant is unknown [see Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.2 )] .
• patients with a history of ...

• Hemolytic Anemia : G6PD testing must be performed before prescribing ARAKODA due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis. ( 5.1 )
• G6PD Deficiency in Pregnancy or Lactation : ARAKODA may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA through breast milk. Check infant’s G6PD status bef...

7 DRUG INTERACTIONS Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters ( 7.1 ) 7.1 Effect of ARAKODA on Organic Cation Transporter-2 (OCT2) and Multidrug and Toxin Extrusion (MATE) Substrates The effect of coadministration of tafenoquine on the pharmacokinetics of OCT2 and MATE substrates in humans is u...