<p>Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Pegfilgrastim was embryotoxic and increased pregnancy loss in pregnant rabbits that received cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. Pegfilgrastim should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.<br />
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Nursing Mothers: It is not known whether Pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman.</p>