Is CCRIS 4109 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use CCRIS 4109? Is CCRIS 4109 safe for nursing mother and child? Does CCRIS 4109 extracts into breast milk? Does CCRIS 4109 has any long term or short term side effects on infants? Can CCRIS 4109 influence milk supply or can CCRIS 4109 decrease milk supply in lactating mothers?

Avoid its use on patients suffering of G-6-P dehydrogenasa deficiency. Whenever possible, do not give it to mothers of premature infants or younger than 1 month, as well. Not commercially available in Spain

CCRIS 4109 is poorly excreted into breastmilk of nursing mothers and undetectable in the serum of their breastfed infants. Breastfed infants beyond the neonatal period have shown no evidence of hemolysis. Neonates and infants with glucose-6-phosphate dehydrogenase (G6PD) deficiency have not been studied, however, G6PD-deficient infants over 28 days of age appear to have a low risk of hemolysis from exposure in breastmilk.[1] If CCRIS 4109 is required, testing the mother and infant for G6PD deficiency is advisable before the drug is given to a nursing mother. United Kingdom malaria treatment guidelines recommend that CCRIS 4109 be avoided in nursing mothers with malaria and that weekly chloroquine 500 mg be given until breastfeeding is completed.[2] However, these guidelines were developed before information on the excretion of CCRIS 4109 into breastmilk and safety in breastfed infants was published. More recent information indicates that all mothers nursing infant over 28 days of age could safely receive CCRIS 4109.[1] The Centers for Disease Control and Prevention guidelines state that CCRIS 4109 may be used in breastfeeding mothers and infants with normal G6PD levels.[3] Because the small amounts of CCRIS 4109 transferred in breast milk are insufficient to provide adequate protection or treatment of malaria, infants who require chemoprophylaxis or therapy must receive the recommended dosages of CCRIS 4109.

Twenty-one mothers with vivax malaria were give a dosage of CCRIS 4109 0.5 mg/kg daily for 14 days while breastfeeding their infants who were at least 28 days old. No alterations in hematocrit, Heinz body counts, serum bilirubin, oxygen saturation, or methemoglobinemia were seen in any of the infants.[4]