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Omalizumab Pregnancy and Breastfeeding Warnings

Omalizumab is also known as: Xolair

Omalizumab Pregnancy Warnings

Omalizumab has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of maternal toxicity, embryotoxicity, or teratogenicity. There are no controlled data in human pregnancy. Omalizumab is only recommended for use during pregnancy when benefit outweighs risk.

Omalizumab Breastfeeding Warnings

There are no data on the excretion of omalizumab into human milk. Studies with cynomolgus monkeys have demonstrated milk levels that were 1.5% of maternal blood levels. IgG is excreted into human milk and it is expected that omalizumab is also excreted. The effects in the nursing infant are unknown. The manufacturer recommends that caution be used when administering omalizumab to nursing women.

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