Pregnancy: There are limited data (less than 300 pregnancy outcomes) from the use of Saphnelo in pregnant women.
Animal studies are inconclusive with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Saphnelo is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the possible benefit justifies the potential risk.
Breast-feeding: It is not known whether anifrolumab is excreted in human milk. Anifrolumab was detected in the milk of female cynomolgus monkeys (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue from Saphnelo therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There are no fertility data in humans.
Animal studies show no adverse effects of anifrolumab on indirect measures of fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).