Is CT-P13 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use CT-P13? Is CT-P13 safe for nursing mother and child? Does CT-P13 extracts into breast milk? Does CT-P13 has any long term or short term side effects on infants? Can CT-P13 influence milk supply or can CT-P13 decrease milk supply in lactating mothers?

IgG1 monoclonal-antibody against tumor necrosis alpha factor (TNFα) which is used to treat autoimmune diseases such as Crohn's disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis. As a matter of fact, because of a very high molecular weight and high plasma protein-binding capacity, it is excreted into breastmilk in an undetectable amount (Mahadevan 2005, Vasiliauskas 2006, Stengel 2008, Kane 2009) or clinically non-significant (Ben-Horn 2011, Fritzsche 2012, Grosen 2014 , Matro 2015). Plasma levels of infants breastfed by mothers who were treated with CT-P13 have resulted to be undetectable or very low (Vasiliauskas 2006, Kane 2009, Fritzsche 2012, Steenholdt 2012). Neither short nor long-term adverse effects on development, immunological response and/or infection rate, nor altered response to vaccination of infants whose mothers were taking CT-P13 have been observed (Mahadevan 2005, Vasiliauskas 2006, Stengel 2008, Kane 2009, Tursi 2010, Puig 2010, Correia 2010 , Fritzsche 2012, Steenholdt 2012). Because it lacks of oral bioavailability, seems difficult any pass to the infant’s plasma through the ingested breastmilk, except on premature infants and immediate neonatal period, in which there may be an increased intestinal permeability. Numerous experts and scientific societies of Rheumatology, Gastroenterology and Dermatology consider it to be a very low risk drug, and therefore, compatible while breastfeeding (Mahadevan 2011, Nielsen 2014, Hyrich 2014, Mahadevan 2015, van der Houde 2015, Nguyen 2016, Flint 2016 , Gotestam 2016).

CT-P13 is usually either not detectable in breastmilk or detectable at very low levels. Absorption of the drug from milk by the infant is minimal. Follow-up of infants exposed in utero and breastfed during maternal CT-P13 therapy have found no adverse effects and normal development. The measurement of minute concentrations in the milk of some women raises the possibility of local immune suppression in the gastrointestinal tact, but levels were not high enough to be of concern for systemic immunosuppression.[1] Although the manufacturer recommends that breastfeeding be discontinued during CT-P13 therapy, numerous experts have stated that the drug is a low risk to the nursing infant and breastfeeding can continue during CT-P13 use.[2][3][4][5][6][7][8][9]

A retrospective chart review of patients who received CT-P13 during pregnancy found that 5 mothers breastfed their infants during CT-P13 therapy at a dose of 5 mg/kg. No other patient details were reported and no adverse effects were reported in the infants, although observation during breastfeeding was not the purpose of the study.[19] A woman with Crohn's disease received CT-P13 5 mg/kg intravenously every 8 weeks throughout pregnancy and during lactation. The infant was reported to be good condition without any evidence of illnesses.[20] An infant was born to a mother who received CT-P13 10 mg/kg 5 times during pregnancy at 6- to 8-week intervals. A maternal dose of 10 mg/kg was given at 2 weeks postpartum. The infant was breastfed for 6 weeks, discontinued for 3 weeks and then reinstated at 9 weeks of age (extent of nursing not stated). Another 10 mg/kg dose was given to the mother at 10 weeks postpartum. The infant underwent a formal evaluation of the immune system and found to have normal immune markers and responses. The infant reportedly grew and developed normally throughout the first year of life.[12] An infant was breastfed (extent not stated) for up to 4 months by a mother who was taking CT-P13 (dosage not stated) and azathioprine 150 mg daily for inflammatory bowel diseases. The infant was followed regularly for 22 months of age and found to have a normal growth rate, and no history of recurrent infections.[21] A woman with severe Crohn's disease received CT-P13 1000 mg (10 mg/kg) intravenously every 4 weeks during pregnancy and lactation. The extent and duration of breastfeeding were not reported. The child had no developmental abnormalities noted at 27 months of age.[13] Three infants were breastfed (extent not stated) during maternal CT-P13 therapy at a dose of 5 mg/kg every 8 weeks. Infants were followed for almost 1 year and found to have no unusual number or types of infections and all seroconverted after their routine childhood immunizations.[14] A 24-year-old woman with Crohn's disease received CT-P13 5 mg/kg every 8 weeks during pregnancy until 33 weeks gestation. After delivering at term, she received her next CT-P13 dose at 1 week postpartum. The infant was breastfed (extent not stated) and received all vaccinations, except rotavirus, on schedule.[22] A woman with severe psoriasis was treated during pregnancy and postpartum with CT-P13 5 mg/kg intravenously every 8 weeks. Her last doses of CT-P13 before delivery were at weeks 20 and 29 of pregnancy. The drug was continued postpartum, although the timing of the first postpartum dose was not stated. Her infant was breastfed for 1 month and developed normally.[23] A woman with Crohn's disease used CT-P13 5 mg/kg every 8 weeks during pregnancy and postpartum. During breastfeeding (extent not stated) she also received sulfasalazine 4 g/day and prednisone 60 mg/day in a tapering schedule. At 6 months of age, the infant was asymptomatic with regular weight gain.[24] Two women received CT-P13 300 mg intravenously for treatment of inflammatory bowel disease. One woman nursed her infant (extent not stated) and the other began partial breastfeeding her infant at 3 months of age when CT-P13 was begun. She breastfed for approximately 5 weeks (2 doses) before discontinuing breastfeeding. At 22 and 18 months of age, respectively, neither infant had any signs of adverse drug reactions, allergic reactions or severe infections leading to hospitalization. The first infant had a low birth weight, but caught up and reached the 75th percentile at the age of 11 months. Developmental milestones were reached on time by both infants.[15] A woman with ulcerative colitis was receiving long-term therapy with mesalamine 4 grams daily throughout pregnancy received inductions series of CT-P13 5 mg/kg in weeks 20 and 31 of pregnancy for disease flares. She continued to receive CT-P13 infusions every 8 to 12 weeks, while the baby was breastfed (extent not stated) until 14 weeks of age. The infant received routine vaccinations (diphtheria, tetanus, pertussis, injectable polio, Haemophilus influenzae b, and pneumococcal vaccines) at 3, 5 and 12 months with no signs of adverse effects from them, or signs of allergic or infectious diseases. Development at 13 months of age was normal.[17] A woman receiving CT-P13 (dosage not stated) every 7 weeks for Crohn's disease became pregnant and CT-P13 was continued until week 25 of pregnancy. She partially breastfed her dizygotic twins for 6 weeks. Her infants had detectable serum CT-P13 levels until 12 months of age. The boy developed normally. The girl was diagnosed with a non-significant atrial septal defect at the age of 6 weeks. At the age of 18 months, she was admitted to hospital due to asthmatic bronchitis. She was seen as an outpatient at the pediatric department due to late gross motor function development, but her monitoring was termi