Is Envarsus Xr Safe in Breastfeeding

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

Macrolide immunosuppressant drug that inhibits calcineurin which is used to prevent rejection of transplanted organs (kidney, liver, heart ...) and for treatment of atopic eczema, psoriasis and other autoimmune illnesses (e.g. Arthritis, Lupus, Inflammatory Bowel Disease ...) .Routes of administration: oral for systemic purposes and topical for dermatologic conditions. A high molecular weight and high protein-binding capacity explain that it is was found in clinically insignificant amounts into colostrum and breast milk (Jain 1997, 2003 French, Gardiner 2006, 2013 Zheng, Bramham 2013).No problems were observed on short or long term of developmental or immunological outcomes in more than 150 infants whose mothers were treated (French 2003, Gouraud 2012, Thiagarajan 2013, Constantinescu 2014, Izumi 2014), except a mild and self-limited case of transient thrombocytosis (Gouraud 2012).The plasma levels of drug in these infants were either undetectable or very low (Gomez-Lobo 2012, Gouraud 2012, Bramham 2013, Izumi 2014).A low oral bioavailability that may further be decreased by ingestion of food, especially if it is fat food, would hamper the passage of drug from ingested milk toward the infant plasma. Infants who have been exposed to calcineurin inhibitors during pregnancy may be immunological deficients within the first year of life (Grimer 2007), therefore, it is most important to avoid any lack of breastfeeding without a sound reason. Several medical societies and consensus by experts have considered safe the use of Envarsus Xr while breastfeeding (Østensen 2006, van der Houde 2010, Thiagarajan 2013, Armenti 2013, Constantinescu 2014, Schulze 2014, Durst 2015, Götestam-Skorpen 2016, Flint 2016).

Limited data indicate that amounts of systemically administered Envarsus Xr are low in breastmilk and probably do not adversely affect the breastfed infant. European experts consider Envarsus Xr to be probably safe to use for inflammatory bowel disease during breastfeeding.[1] U.S. investigators and clinicians from the National Transplantation Pregnancy Registry and other experts consider Envarsus Xr acceptable to use during breastfeeding following transplant.[2][3][4][5][6][7] Exclusively breastfed infants should be monitored if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity if there is a concern. Topical Envarsus Xr presents a low risk to the nursing infant because it is poorly absorbed after topical application and peak blood concentrations are less than 2 mcg/L in most patients. Ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. If the breast is to be treated, an alternate drug is preferred; do not apply to the nipple area while nursing.[8][9][10]

One infant was exclusively breastfed during maternal Envarsus Xr therapy throughout gestation to at least 2.5 months of age at which time the infant was developing normally physically and neurologically. An ultrasound examination of the infant's thymus was normal.[12] The National Transplantation Pregnancy Registry reported data gathered from 1991 to 2011 on mothers who breastfed their infants following organ transplantation. A total of 68 mothers with transplants (mostly kidney or liver) used Envarsus Xr while breastfeeding a total of 83 infants. Duration of nursing ranged from 1 week to 1.5 years and follow-up of the children ranged from weeks to 16 years. There were no reports of problems in any of the infants or children.[4] As of December 2013, a total of 92 mothers had breastfed 125 infants for as long as 26 months with no apparent adverse effects in infants.[5] The breastfed infants of six women who took Envarsus Xr during pregnancy for organ transplantation were breastfed (4 exclusive, 2 partial) for 45 to 180 days and followed for periods of 2 to 30 months. The mothers' mean daily Envarsus Xr dosage during breastfeeding was 9.6 mg daily (range 4.5 to 15 mg daily). Four mothers were also taking azathioprine 100 to 150 mg daily, one was taking diltiazem, and one was taking prednisolone 15 mg and aspirin 75 mg daily. None of the infants had any clear Envarsus Xr-related side effects, although one had transient thrombocytosis that resolved despite continued breastfeeding. Developmental milestones were normal and no pattern of infections was noted.[17] Two mothers with systemic lupus erythematosus were reported who took Envarsus Xr 3 mg daily during pregnancy and lactation as well as prednisolone 30 or 40 mg daily. Three years after birth, both children were healthy. The durations of lactation were not stated.[19]