Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Pregnancy

There are no data on the use of ceftolozane/tazobactam in pregnant women. Tazobactam crosses the placenta.
It is not known if ceftolozane crosses the placenta.
Animal studies with tazobactam have shown reproductive toxicity (see section 5.3) without evidence of teratogenic effects. Studies with ceftolozane in mice and rats have not shown evidence of reproductive toxicity or teratogenicity. Ceftolozane administered to rats during pregnancy and lactation was associated with a decrease in auditory startle response in postnatal day (PND) 60 male pups (see section 5.3).

Zerbaxa should only be used during pregnancy if the expected benefit outweighs the possible risks to the pregnant woman and foetus.

Breast-feeding

It is unknown whether ceftolozane and tazobactam are excreted in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zerbaxa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

The effects of ceftolozane and tazobactam on fertility in humans have not been studied. Fertility studies in rats showed no effect on fertility and mating after intraperitoneal administration of tazobactam or intravenous administration of ceftolozane (see section 5.3).