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Pregnancy: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of benralizumabin in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Monoclonal antibodies such as benralizumab are transported across the placenta linearly as pregnancy progresses; therefore, potential exposure to a fetus is likely to be greater during the second and third trimesters of pregnancy.
As a precautionary measure, it is preferable to avoid the use of FASENRA during pregnancy. Its administration to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Breastfeeding: It is unknown whether benralizumab or its metabolites are excreted in human or animal milk. A risk to the breastfed child cannot be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from using FASENRA, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: There are no fertility data in humans. Animal studies showed no adverse effects of benralizumabtreatment on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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