Paxlovid Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: There are no human data on the use of Paxlovid during pregnancy to inform the drug-associated risk of adverse developmental outcomes, women of childbearing potential should avoid becoming pregnant during treatment with 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 and until after one complete menstrual cycle after stopping Paxlovid (see Interactions).
Pregnancy: There are no data from the use of Paxlovid in pregnant women. Paxlovid is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
There was no nirmatrelvir-related effect on foetal morphology or embryo-foetal viability at any dose tested in rat or rabbit embryo-foetal developmental toxicity studies (see Pharmacology: Preclinical safety data under Actions).
A large number of pregnant women were exposed to ritonavir during pregnancy. These data largely refer to exposures where ritonavir was used in combination therapy and not at therapeutic ritonavir doses but at lower doses as a pharmacokinetic enhancer for other protease inhibitors, similar to the ritonavir dose used for nirmatrelvir/ritonavir. These data 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 Pharmacology: Preclinical safety data under Actions).
Breast-feeding: There are no human data on the use of Paxlovid in breast-feeding.
It is unknown whether nirmatrelvir is excreted 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 the effects of the medicinal product on milk production. A risk to the newborn/infant cannot be excluded. Breast-feeding should be discontinued during treatment with Paxlovid and for 7 days after the last dose of Paxlovid.
Fertility: There are no human data on the effect of Paxlovid on fertility. No human data on the effect of nirmatrelvir on fertility are available. Nirmatrelvir produced no effects on fertility in rats (see Pharmacology: Preclinical safety data under Actions).
There are no human data on the effect of ritonavir on fertility. Ritonavir produced no effects on fertility in rats.