Certolizumab Pegol use while Breastfeeding
Drugs containing Certolizumab Pegol: Cimzia
Medically reviewed on March 1, 2018.
Certolizumab Pegol Levels and Effects while Breastfeeding
Summary of Use during Lactation
Certolizumab is not excreted into breastmilk, which would be expected because of its high molecular weight. Absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Most experts consider certolizumab to be probably safe during breastfeeding. The European Medicines Agency has deemed certolizumab pegol acceptable to use during breastfeeding.
Maternal Levels. One woman received certolizumab pegol 400 mg by subcutaneous injection every 4 weeks during pregnancy and postpartum. The last dose during pregnancy was 1 week prior to delivery. Breastmilk samples were collected 1 and 2 weeks postpartum and 4 hours, 3 days and 6 days after the first postpartum dose which was given at 3 weeks postpartum. Certolizumab was undetectable (<410 mcg/L) in all 5 samples.
Three women who received certolizumab pegol (dose unspecified) as part of a large registry study submitted breastmilk samples. Certolizumab was not detected in any samples between 12 and 24 hours after infusion.
Two women were receiving certolizumab pegol 200 mg every two weeks. Certolizumab was undetectable (<0.6 mg/L) in breastmilk one hour after the dose in both women and 4 hours after the dose in one of them.
Seventeen nursing mothers who were taking certolizumab pegol for an inflammatory condition and were at least 6 weeks postpartum had certolizumab measured in their breastmilk at least 8 times over a dosage interval. The maternal dose was 200 mg every 2 weeks in 16 women and 400 mg every 4 weeks in another. Out of 137 breastmilk samples, 77 had no detectable certolizumab and 4 mothers had no detectable (<0.032 mg/L) certolizumab in milk at any time point, including the mother who received the 400 mg dose. Of the 13 other mothers, the highest concentrations found were 0.076 mg/L, which was found in one woman at 6 and 8 days after the dose, and 0.65 and 0.66 mg/L in another at 4 and 6 days after the dose, respectively. All other mothers with detectable certolizumab had milk levels that were less than 0.064 mg/L. The median time of peak milk levels was 5.05 days (range 2.9 to 11.9 days). The estimated average daily infant dose ranged from 0 to 0.0104 mg/kg daily. The median weight-adjusted relative infant dosage was calculated by the authors to be 0.15% (range 0.04 to 0.3%). No measurable levels of total polyethylene glycol were detected in 134 of 137 breast milk samples; 3 samples had indeterminate results upon retesting.
Infant Levels. One woman received certolizumab pegol 400 mg by subcutaneous injection every 4 weeks during pregnancy and postpartum. The last dose during pregnancy was 1 week prior to delivery. At birth, her infant had a serum concentration 1.02 mg/L At one month of age, her breastfed (extent not stated) infant had a serum concentration of 0.84 mg/L seven days after the previous injection.
Effects in Breastfed Infants
Eight women who received certolizumab pegol during pregnancy and postpartum breastfed (extent not stated) their infants. No mention was made of side effects in the infants.
A prospective cohort study followed pregnant women with inflammatory bowel disease throughout pregnancy and for 12 months postpartum. Women were assigned to one of the following groups: unexposed (no thiopurines or anti-TNF agents); group A (azathioprine or mercaptopurine); group B (infliximab, adalimumab or certolizumab) and group AB (both a thiopurine and an anti-TNF agent). Of 1052 women enrolled in the study, 72% breastfed their infants, although the extent and duration were not stated in the abstract. A total of 102 women were exposed to an anti-TNF agent and 59 were exposed to a thiopurine plus an anti-TNF agent. The use of an anti-TNF alone was not associated with any complication in the infants and their growth and development were normal throughout the 12 months. Infants exposed to both a thiopurine and an anti-TNF agent had a 50% increase in the number of infections between 9 and 12 months of age. The relationship of this increase with breastfeeding could not be determined from the available data.
Seventeen mothers took certolizumab pegol for an inflammatory condition and breastfed their infants. During a study period starting at least 6 weeks postpartum and after at least 3 doses of certolizumab pegol, 8 of the infants experienced 11 adverse effects. None of the infants had any unusual or serious adverse reactions attributed to the drug and all effects were consistent with events typically experienced by infants of the same age, such as upper respiratory infection, candidal infection, or vomiting.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
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Certolizumab Pegol Identification
CAS Registry Number
Immunoglobulin Fab Fragments
LactMed Record Number
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