Is RO76477 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use RO76477? Is RO76477 safe for nursing mother and child? Does RO76477 extracts into breast milk? Does RO76477 has any long term or short term side effects on infants? Can RO76477 influence milk supply or can RO76477 decrease milk supply in lactating mothers?

Risperidone and its metabolite (RO76477) are excreted into breast milk in non-significant amount. Untoward effect has not been observed on breastfed infants of treated mothers. Serum levels were very low or undetectable in these infants. May be a cause of galactorrhea. Thera are two types of RO76477: oral and intramuscular (Depo). Depo type (RO76477 Palmitate) requires intramuscular administration with a Time to Max of 13 days and a Half-time of 25 to 50 days. That would be a reason to use during breastfeeding a non-depot (oral) medication like Risperidone or any suggested alternative, as a safer choice.

Although no data are available for the use of RO76477 during breastfeeding, it is the active metabolite of risperidone. Risperidone data indicate that the concentrations of RO76477 (9-hydroxyrisperidone) in breastmilk are low, and amounts ingested by the infant are small. Because there is no published experience with RO76477 during breastfeeding and little long-term follow-up data, other agents may be preferred, especially while nursing a newborn or preterm infant. Because RO76477 is available only as a sustained-release product, timing of nursing with respect to doses would not be useful.

No published information on RO76477 was found as of the revision date. However, limited data from the use of its parent drug, risperidone, during nursing indicate no short- or long-term adverse effects on the infant.[3][4][5]

RO76477 has caused elevated prolactin serum levels, gynecomastia, and galactorrhea in patients taking the drug.[6][7][8][9][10][11] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.