Animal studies have failed to reveal evidence of teratogenicity or embryotoxicity. Placental transfer to the fetus has been reported as low (cord blood/maternal delivery plasma drug ratio less than 0.3). There are no controlled data in human pregnancy.

The Pediatric AIDS Clinical Trials Group (PACTG) confirmed previous studies that showed minimal transplacental passage of this drug.

This drug is not recommended as part of initial combination therapy for antiretroviral-naive pregnant women; it requires baseline ECG (due to potential PR and QT prolongation), has a large pill burden, and is not recommended as part of initial therapy for nonpregnant patients.

To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com

The APR has received prospective reports of about 400 exposures to saquinavir-containing regimens. Too few first-trimester exposures to this drug (less than 200) have been monitored to accurately calculate prevalence of birth defects in exposed cases.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; caution is recommended.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comments:
-A pregnancy exposure registry is available.

See references

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant are unknown.
-The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.
-Local guidelines should be consulted if replacement feeding is not an option.

See references