Vedolizumab levels are "minute" in breast milk

Reuters Health Information: Vedolizumab levels are "minute" in breast milk

Vedolizumab levels are "minute" in breast milk

Last Updated: 2017-09-13

By Reuters Staff

NEW YORK (Reuters Health) - Vedolizumab is detectable in the breast milk of nursing mothers who take the inflammatory bowel disease (IBD) drug, according to a new report.

"Although more data are imperative, the concentrations of vedolizumab in breast milk are minute and are therefore unlikely to result in systemic or gastrointestinal immune suppression of the infant," Dr. Adi Lahat of Tel-Aviv University in Israel and colleagues conclude.

Nursing is typically advocated for mothers with IBD, and to date studies of nursing mothers on infliximab, adalimumab, and natalizumab have found no negative effects on infant development, the researchers note in their August 31 online report in the Journal of Crohn's and Colitis. One study in monkeys found vedolizumab was detectable in breast milk, but drug levels have not been investigated in humans, they add.

To investigate, the researchers prospectively recruited eight postpartum IBD patients (including five who were taking vedolizumab when they conceived and three who started the drug after they began breastfeeding) and five healthy nursing mothers (controls). Of the three IBD patients whose breast milk was tested for vedolizumab before they began treatment, none had detectable levels; nor did any of the controls.

All five of the mothers who were already taking vedolizumab had measurable levels of the drug in their breast milk.

On serial post-infusion measurements, breast milk levels of vedolizumab reached a maximum of 478 ng/mL, much lower than trough serum levels (up to 18,000 mg/mL).

Vedolizumab breast milk levels peaked at about 3 or 4 days post-infusion and then gradually declined - but did not exceed roughly 480 ng/mL.

Infants of the IBD patients, followed for up to 10 months, had no increases in gastrointestinal or other infections, and all reached the appropriate developmental milestones.

"Milk drug level is minute, and more than two orders less than its level in serum," Dr. Lahat and colleagues write. "This low level is hypothesized to be further degraded by the newborn's intestinal proteolytic activity, thereby having a negligible effect on infant's immune system. However, this assertion was not assessed herein directly, so further studies are warranted to address systemic effects, if any, of oral vedolizumab exposure on the suckling infant."

They conclude that their study, though small, "may be reassuring (to) clinicians and patients regarding the safety of breast feeding with vedolizumab" and that "if corroborated by further studies, the present findings may thereby positively impact the lives of the many IBD patients wishing to breastfeed."

Dr. Lahat was not available for an interview by press time.


J Crohns Colitis 2017.

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