Nucala Use In Pregnancy & Lactation

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: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
Mepolizumab crosses the placental barrier in monkeys. Animal studies do not indicate reproductive toxicity (see Pharmacology: Toxicology: Pre-clinical Safety Data under Actions). The potential for harm to a human fetus is unknown.
As a precautionary measure, it is preferable to avoid the use of NUCALA during pregnancy. Administration of NUCALA to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Lactation: There are no data regarding the excretion of mepolizumab 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.