Tafenoquine Pregnancy and Breastfeeding Warnings

Brand names: Arakoda, Krintafel

Medically reviewed by Drugs.com. Last updated on Nov 9, 2023.

Tafenoquine Pregnancy Warnings

Use is not recommended.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug may cause hemolytic anemia in a glucose-6-phosphate dehydrogenase (G6PD)-deficient fetus.
-If the patient becomes pregnant during therapy, this drug should be discontinued as soon as possible, and the patient should be switched to an alternative prophylactic agent for malaria during pregnancy.
-Maternal and/or embryo/fetal risk due to the mother's underlying condition should be considered.
-Females of reproductive potential: Pregnancy status should be verified before starting treatment with this drug; such patients should be advised to avoid pregnancy or use effective contraception for 3 months after the last dose of this drug.

Animal studies have revealed evidence of an increased incidence of abortions (with and without maternal toxicity) but have failed to reveal evidence of fetotoxicity or teratogenicity; no evidence of malformations seen in rabbits or rats. Dose-related abortions observed when oral doses of 7 mg/kg (about 0.4 times the clinical exposure based on body surface area [BSA] comparisons) and more were given to pregnant rabbits during organogenesis; maternal toxicity (mortality, reduced body weight gain) also observed with doses higher than 7 mg/kg. In rats, maternal toxicity (enlarged spleen, reduced body weight, reduced food intake) observed at doses of 3, 10, or 30 mg/kg/day but no fetotoxicity at 30 mg/kg/day (equal to or about 1.5 times the clinical exposure based on BSA comparisons). There are no controlled data in human pregnancy.

According to some authorities: Because the G6PD status of the fetus is unknown, use of this drug is contraindicated during pregnancy.

Malaria during pregnancy increases risk for adverse pregnancy outcomes (including maternal anemia, prematurity, spontaneous abortion, stillbirth).

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Tafenoquine Breastfeeding Warnings

Use is contraindicated in breastfeeding women when infant is glucose-6-phosphate dehydrogenase (G6PD) deficient or if G6PD status of infant is unknown.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No data available regarding use of this drug during nursing.
-A breastfed infant with G6PD deficiency is at risk for hemolytic anemia from exposure to this drug; infant G6PD status should be checked before breastfeeding is started.
-If a woman has an infant with G6PD deficiency or unknown G6PD status, she should be advised not to breastfeed during therapy and for 3 months after the last dose of this drug.
-In breastfed infants with normal G6PD: Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug. The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer