Is Vedolizumab safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Vedolizumab. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
Eight women who were receiving vedolizumab for inflammatory bowel disease were breastfeeding their infants (extent not stated). Dosages were 300 mg intravenously, at 1 to 2 month intervals for 6 and starting during induction for 2 women. No increase in general or gastrointestinal tract infections were seen in the newborns up to 10 months of age and all infants reached their development milestones.[ 8 ] Five infants were breastfed by mothers receiving vedolizumab 300 mg intravenously at regular intervals. The infants all had normal developmental milestones at 3.5 to 10 months of age. All of the infants received routine inactivated vaccines without complications.[ 9 ] A multicenter, retrospective study in Belgium reported on women with inflammatory bowel disease during pregnancy and postpartum who received vedolizumab (n = 23). Twelve infants were breastfed by their mothers and were followed for a median of 23 weeks (IQR 10 to 60 weeks). Twenty of the 23 infants were vaccinated with the standard Belgian protocol, with 9 also receiving rotavirus vaccination. No serious infections or malignancies were reported.[ 12 ] In an extension of this study, 70 women who received vedolizumab were compared to those who received a TNF antagonist (n = 162) and to those who received no biological or immunologic therapy (n = 163). Sixty-two percent of women on vedolizumab breastfed their infants compared to 60% and 64% in the other groups. No malignancies were reported in any of the children during the first year of life and the number of infant infections were not statistically different between the groups. The extent of breastfeeding and postpartum dosage regimens were not stated.[ 13 ] The manufacturer s database of adverse drug events up to May 2019 included 21 adverse events in breastfed infants whose mothers were taking vedolizumab. None of them were judged to be serious.[ 10 ] No details of the types of reactions were reported. Forty-three women who received vedolizumab 300 mg a
Effects on milk supply
A study of the milk of women with or without inflammatory bowel disease (IBD) found that the use of vedolizumab to treat IBD did not affect the amount of SIgA or SIgM in the milk.[ 19 ]
Levels in milk
Maternal Levels. Five lactating women who were receiving vedolizumab for inflammatory bowel disease donated milk samples at various times after receiving a dose of 300 mg intravenously. Four were on maintenance therapy every 1 to 2 months and 1 was in the induction phase and had received 2 doses of the drug 2 weeks apart. Peak breastmilk levels occurred from day 2 to 4 after the dose with a median of day 3. Peak milk concentrations averaged 354 mcg/L (range 108 to 478 mcg/L). One woman collected milk daily for 15 days. Her breastmilk levels slowly decreased from a peak of 405 mcg/L on day 3 to 101 mcg/L on day 15.[ 8 ] Five nursing mothers were receiving vedolizumab 300 mg intravenously at unspecified intervals for inflammatory bowel disease. Breastmilk samples were collected before a dose, 30 minutes after a dose and twice daily thereafter for up to 14 days. Trough samples contained 124 to 228 mcg/L of vedolizumab. Most breastmilk levels were between 150 and 250 mcg/L. The highest breastmilk vedolizumab milk levels were variable and ranged from 196 to 318 mcg/L on days 3 through 7. Using the highest level measured, the authors calculated that an infant would receive an oral dose of 0.048 mg/kg of vedolizumab daily.[ 9 ] Eleven women with inflammatory bowel disease were receiving vedolizumab 300 mg intravenously at various intervals, nine every 8 weeks, and one each at 4 and 6 week intervals. Complete expression of breastmilk from both breasts was done before the dose on day 1 of therapy, then at 1 hour after the infusion and on days 1, 4, 8, 15, 29, and 57 after the dose. The median time to peak milk level was 3 to 4 days after the dose with a mean peak value of 252 mcg/L (range, 98 to 561 mcg/L) in the 9 women receiving the drug every 8 weeks. The mean trough level at 57 days after the dose was 47.1 mcg/L. The average daily milk concentration over the 8-week dosing interval was 129 mcg/L (range 0.032 to 0.26 mcg/L). The geometric mean daily infant dosage was 0.019
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.