Xofluza Use In Pregnancy & Lactation

Females and Males of Reproductive Potential: Fertility: No effects on fertility were observed in animal studies performed with baloxavir marboxil (see Pharmacology: Toxicology: Preclinical safety data: Impairment of Fertility under Actions).
Pregnancy: There are no adequate and well-controlled studies with XOFLUZA in pregnant women. The potential risk of XOFLUZA in pregnant women is unknown. XOFLUZA should be avoided during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Baloxavir marboxil did not cause malformations in rats or rabbits. High dose levels of baloxavir marboxil given to pregnant rabbits caused maternal toxicity resulting in miscarriages and an increase in the incidence rates of minor skeletal abnormalities in rabbits but no malformations. Such effects were not seen in rats (see Pharmacology: Toxicology: Preclinical safety data: Reproductive toxicity under Actions.)
Labor and Delivery: The safe use of XOFLUZA during labor and delivery has not been established.
Lactation: It is not known whether baloxavir marboxil and the active metabolite, baloxavir, are excreted in human breast milk. When dosed at 1 mg/kg baloxavir marboxil or its metabolites are secreted in the milk of lactating rats.
Therefore, a decision should be made whether to discontinue nursing or to initiate treatment with XOFLUZA, taking into consideration the potential benefit of XOFLUZA to the nursing mother and the potential risk to the infant.