Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential
There are no data on the use of Paxlovid in pregnant women to inform the drug-associated risk of adverse developmental outcomes; women of childbearing potential should avoid becoming pregnant during treatment with Paxlovid and as a precautionary measure for 7 days after completing Paxlovid.

Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Patients using combined hormonal contraceptives should be advised to use an effective alternative contraceptive method or an additional barrier method of contraception during treatment with Paxlovid, and until one menstrual cycle after stopping Paxlovid (see section 4.5).

Pregnancy

There are limited data from the use of Paxlovid in pregnant women.
Animal data with nirmatrelvir have shown developmental toxicity in the rabbit (lower foetal body weights) but not in the rat (see section 5.3).

A large number of women exposed to ritonavir during pregnancy indicate no increase in the rate of birth defects compared to rates observed in population-based birth defect surveillance systems.



Animal data with ritonavir have shown reproductive toxicity (see section 5.3).

Paxlovid is not recommended during pregnancy and in women of childbearing potential not using contraception unless the clinical condition requires treatment with Paxlovid.

Breast-feeding

There are no data on the use of Paxlovid in breast-feeding women.
It is unknown whether nirmatrelvir is present in human or animal milk, and the effects of it on the breast-fed newborn/infant, or the effects on milk production. Limited published data reports that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breast-fed newborn/infant or on milk production. A risk to the newborn/infant cannot be excluded.
Breast-feeding should be discontinued during treatment and as a precautionary measure for 7 days after completing Paxlovid.

Fertility

There are no human data on the effect of Paxlovid (nirmatrelvir and ritonavir) or ritonavir alone on fertility. Both nirmatrelvir and ritonavir, tested separately, produced no effects on fertility in rats (see section 5.3).