Tezspire Use In Pregnancy & Lactation

Pregnancy: The data on pregnancy exposure from the clinical studies are insufficient to inform on drug-associated risk.
In a prenatal and postnatal development study conducted in cynomolgus monkeys, following intravenous (IV) administration of tezepelumab up to 300 mg/kg/week from early gestation through delivery, no adverse effects on maternal health, pregnancy outcome, embryo-foetal development, or neonatal development were observed (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Human IgG antibodies, such as tezepelumab, are transported across the placenta barrier; therefore, TEZSPIRE may be transmitted from the mother to the developing foetus.
It is recommended not to use TEZSPIRE during pregnancy unless the expected benefit to the pregnant mother is greater than any possible risk to the foetus.
Breast-feeding: It is unknown whether tezepelumab is excreted in human milk. However, IgG antibodies are known to be present in human milk. Risk to the breast-fed child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from using TEZSPIRE, taking into account the benefit and risk of breast-feeding 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 tezepelumab treatment on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).