Pregnancy: The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk.
Monoclonal antibodies such as benralizumab are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential exposure to a fetus is likely to be greater during the second and third trimester of pregnancy.
In a pre- and postnatal development study conducted in cynomolgus monkeys there were no maternal, embryo-fetal, or postnatal developmental effects observed for benralizumab doses 10 or 30 mg/kg IV (bolus) beginning on gestation day (GD) 20 to GD22, on GD35, and once every 14 days thereafter through gestation and 1-month postpartum (see Pharmacology: Toxicology: Preclinical safety data under Actions).
It is preferable to avoid the use of FASENRA during pregnancy. Administration of FASENRA to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus.
Lactation: It is unknown whether benralizumab or its metabolites are excreted in human or animal milk, therefore risk to the breastfed child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from benralizumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Fertility: No fertility studies have been conducted in humans.
Fertility parameters were assessed in a 9 month repeat dose study in cynomolgus monkeys at IV doses up to 25 mg/kg or at SC doses of up to 30 mg/kg once every 2 weeks (approximately 409 and 275 times the MRHD on an AUC basis, and 396 and 193 times the MRHD on a Cmax basis). No benralizumab-related adverse changes in reproductive parameters of female or male cynomolgus monkeys were observed.