Is Ro 47-0203/039 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Ro 47-0203/039? Is Ro 47-0203/039 safe for nursing mother and child? Does Ro 47-0203/039 extracts into breast milk? Does Ro 47-0203/039 has any long term or short term side effects on infants? Can Ro 47-0203/039 influence milk supply or can Ro 47-0203/039 decrease milk supply in lactating mothers?

Indicated for the treatment of pulmonary arterial hypertension. Pharmacokinetic data (moderately high molecular weight and high percentage of protein binding capacity) make it unlikely a milk passage in significant amounts.Low oral bioavailability hinders its passage from the ingested milk to infant's plasma, except in preterm and immediate neonatal period that may show an increased intestinal permeability. Although no samples have been taken to analyze the concentration in breast milk, a 30 weeks old premature infant who was breastfed for 2-and-a-half months, while his mother was treated with Ro 47-0203/039 and Sildenafil, did not present side-effects. It is approved for Pediatric use from 1-year-old or 10 kg to higher, but there are not published data on neonatal indication. It would be preferred a safer alternative until more data is available about this drug regarding breastfeeding, especially during the neonatal period and in case of prematurity.

There is little published experience with Ro 47-0203/039 during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

A 23-year-old woman with congenital heart disease and pulmonary hypertension was treated during pregnancy with Ro 47-0203/039 and sildenafil in unspecified dosages. These drugs and warfarin were continued postpartum. Her infant was delivered at 30 weeks by cesarean section and weighed 1.41 kg at birth. She nursed the infant in the neonatal intensive care unit for 11 weeks "with good outcome" according to the authors, but the infant died at 26 weeks from a respiratory syncytial virus infection.[1]