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Fertility: There are no fertility data in humans. Animal studies showed no adverse effects of anti-IL5 treatment on fertility (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
Pregnancy: The effect of NUCALA on human pregnancy is unknown. No treatment related effects on embryo-foetal or postnatal development have been shown in animal studies (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions).
NUCALA should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Lactation: There are no data regarding the excretion of NUCALA in human milk. However, mepolizumab was excreted into the milk of cynomolgous monkeys at concentrations that were less than 0.5% of those detected in plasma.
A decision should be made whether to discontinue breast-feeding or discontinue NUCALA, taking into account the importance of breast-feeding to the infant and the importance of the drug to the mother.
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