Is Omalizumab safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Omalizumab. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Preliminary evidence indicates that the amount of omalizumab in milk is very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal.[1] Many infants have been breastfed during maternal omalizumab therapy, with no increase in infectious complications. Omalizumab is considered acceptable to use during breastfeeding.[2-5] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[6]
Effects on the breastfed infant
A manufacturer-based omalizumab pregnancy registry has followed pregnant and nursing mothers for several years. Of 230 infants followed, 154 were breastfed while their mothers were taking omalizumab. Another 32 were breastfed without being exposed to the drug in milk and 44 were not breastfed. No difference in serious adverse events were seen among the three groups of infants. Infections occurred at a similar rate in all groups.[8]
Several case reports of infants being breastfed during maternal omalizumab therapy have been published. No adverse effects have been found.[9-13]
A woman with cystic fibrosis and severe, persistent asthma was started on omalizumab 600 mg subcutaneously every 2 weeks. She was maintained on this regimen for 5 years when she became pregnant. The regimen was continued during pregnancy and postpartum. She breastfed (extent not stated) for 8 months. At 10 months of age, her infant was in good health.[14]
A retrospective study in a hospital in China found 5 infants who were breastfed during maternal omalizumab use at a dosage of 150 to 300 mg every 4 weeks. No adverse effects were seen in the infants. [15]
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. A woman received omalizumab 5 weekly doses of omalizumab 150 mg subcutaneously during pregnancy until 28 weeks of gestation. Breastmilk omalizumab levels were determined on days 4 and 5 postpartum, which were 85 and 86 days after the last dose of omalizumab. Four concentrations in milk were below 2 mcg/L and one was just over 8 mcg/L.[7]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Omalizumab” (LM890). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.