Is Cyclosporine safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Cyclosporine. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
One infant was breastfed and follow-up showed that the infant remained healthy and normal.[ 13 ] A mother who was taking cyclosporine 3 mg/kg twice daily completely breastfed her infant until weaning with partial breastfeeding until 14 months. The infant's kidney function was stable, and she was healthy at 2 years of age. This mother also breastfed a second infant.[ 15 ] In 7 infants breastfed for 4 to 12 months during maternal cyclosporine and prednisolone (plus azathioprine in 6 of the 7), infant renal function was unaffected, and they grew normally.[ 16 ] One mother partially breastfed her infant during cyclosporine, azathioprine and prednisone use. No follow-up data were reported.[ 14 ] One infant was exclusively breastfed for 10.5 months during maternal use of cyclosporine 300 mg twice daily, azathioprine and prednisone. Partial breastfeeding continued for 2 years. The infant thrived with normal growth at 12 months. The mother also breastfed a second child while on the same drug regimen.[ 17 ] Four infants breastfed during maternal cyclosporine use. In three, no adverse effects were noted clinically on follow-up and one of these had normal serum creatinine and urea nitrogen (BUN) measured. No follow-up was reported on the fourth infant.[ 18 ] Two cases were reported of infants whose mothers were taking cyclosporine and breastfeeding. One mother was taking cyclosporine 200 mg daily as well as azathioprine, prednisone, diltiazem, and folate. The second mother was taking cyclosporine 120 mg daily as well as methyldopa, prednisone, and calcitriol. Both mothers exclusively breastfed their infants initially and continued for 5 and 14 months, respectively. The infants were reportedly healthy and had normal renal function.[ 23 ] A woman with severe ulcerative colitis during pregnancy received cyclosporine 5 mg/kg daily from 26 weeks of pregnancy and continued while breastfeeding. She extensive breastfed her infant and at 3 months of age the infant was healthy.[ 24 ] Th
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. Early reports measured cyclosporine in breastmilk unsystematically. Cyclosporine levels of 101, 109 and 263 mcg/L were detected in random samples of breastmilk on days 2, 3 and 4 postpartum from a woman taking 450 mg daily orally. [ 9 ] In one woman, a single milk concentration of 16 mcg/L was measured 22 hours after an oral dose of 325 mg given 2 hours before the onset of labor.[ 10 ] One mother's cyclosporine milk concentration averaged about 17% (range 12 to 22%) of simultaneous serum levels.[ 11 ] In another mother, milk cyclosporine levels ranged from 15 to 90% higher than simultaneous serum levels. However, the authors estimated that a breastfed infant would receive less than 5% of an immunosuppressive dose.[ 12 ] One breastfed infant was estimated to have a daily cyclosporine intake of 6 mcg/kg daily during maternal use of 225 mg daily of cyclosporine.[ 13 ] A case series of 3 mothers found the following cyclosporine levels in colostrum. The first mother received 200 mg every 12 hours and had a colostrum level of 418 mcg/L 12 hours her last predelivery dose. The second mother was taking 150 mg every 12 hours and had a mean of 99 mcg/L (range 36 to 209 mcg/L) in 5 colostrum samples taken 3 to 5 days after delivery; The third mother was taking a dose of 125 mg every 12 hours and had levels of 45 to 83 mcg/L in 7 colostrum samples taken during the first 4 days postpartum; milk levels were 105 to 203 mcg/L in samples taken during days 6 to 10 postpartum.[ 14 ] A mother taking 3 mg/kg twice daily with a blood trough cyclosporine blood level of 260 mcg/L had average milk levels of 596 mcg/L 5 weeks postpartum with milk levels varying with the time after the dose. The authors estimated that a fully breastfed infant would receive less than 0.1 mg/kg daily or less than 1.7% of the maternal weight-adjusted dosage.[ 15 ] Five mothers taking cyclosporine in unspecified dosages had random milk levels ranging from 50 to 227 mcg/L in the immediate postpartu
Alternatives LactMed lists
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.