Tafenoquine may increase dofetilide concentrations via OCT2/MATE transporter inhibition, raising toxicity risk. Monitor for toxicities and consider dosage reduction.
Source: NLP:tafenoquine succinate
Brand names: Krintafel
Route: Oral
Contraindications
4 CONTRAINDICATIONS KRINTAFEL is contraindicated in: • Patients with G6PD deficiency or unknown G6PD status due to the risk of hemolytic anemia [see Warnings and Precautions ( 5.1 )] . • 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 Use in Specific Populations ( 8.2 )]. • Patients with known hypersensitivity to tafenoquine, other 8-aminoquinolines, or any component of KRINTAFEL [see Warnings and Precautions ( 5.5 )] . • G6PD deficiency or unknown G6PD status. ( 4 ) • Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown. ( 4 , 8.2 ) • Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of KRINTAFEL. ( 4 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary The use of KRINTAFEL during pregnancy may cause hemolytic anemia in a fetus who is G6PD deficient. Treatment with KRINTAFEL during pregnancy is not recommended [see Warnings and Precautions ( 5.2 )] . Available data with use of KRINTAFEL in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, there were increased abortions, with and without maternal toxicity, when KRINTAFEL was given orally to pregnant rabbits at and above doses equivalent to about 0.4 times the clinical exposure based on body surface area comparisons. No fetotoxicity was observed at doses equivalent to the clinical exposure (based on body surface area comparisons) in a similar study in rats. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth. Data Animal Data: Tafenoquine resulted in dose-related abortions when given orally to pregnant rabbits during organogenesis (Gestation Days 6 to 18) at doses of 7 mg/kg (about 0.4 times the clinical exposure based on body surface area comparisons) and above. Doses higher than 7 mg/kg were also associated with maternal toxicity (mortality and reduced body weight gain). In a similar study in rats, doses of 3, 10, or 30 mg/kg/day resulted in maternal toxicity (enlarged spleen, reduced body weight, and reduced food intake) but no fetotoxicity at the high dose (equivalent to the cli
2 interactions on record
Tafenoquine may increase dofetilide concentrations via OCT2/MATE transporter inhibition, raising toxicity risk. Monitor for toxicities and consider dosage reduction.
Source: NLP:tafenoquine succinate
Tafenoquine may increase metformin concentrations via OCT2/MATE transporter inhibition, raising toxicity risk. Monitor for toxicities and consider dosage reduction.
Source: NLP:tafenoquine succinate