Isentress Use In Pregnancy & Lactation

Pregnancy: A large amount of data on pregnant women with exposure to raltegravir 400 mg twice daily during the first trimester (more than 1,000 prospective pregnancy outcomes) indicates no malformative toxicity. Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A moderate amount of data on pregnant women with exposure to raltegravir 400 mg twice daily during the second and/or third trimester (between 300-1,000 prospective pregnancy outcomes) indicates no increased risk of feto/neonatal toxicity.
400-mg: Raltegravir 400 mg twice daily can be used during pregnancy if clinically needed.
600-mg: There are no data for the use of raltegravir 1,200 mg once daily in pregnant women.
Raltegravir 1,200 mg is not recommended during pregnancy.
Anti-retroviral Pregnancy Registry: To monitor maternal-foetal outcomes in patients inadvertently administered raltegravir while pregnant, an Anti-retroviral Pregnancy Registry has been established. Physicians are encouraged to register patients in this registry.
As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
Breast-feeding: Raltegravir/metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely. Available pharmacodynamics/toxicological data in animals have shown excretion of raltegravir/metabolites in milk (for details see Pharmacology: Toxicology: Preclinical safety data under Actions).
A risk to the newborns/infants cannot be excluded.
It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV.
Fertility: No effect on fertility was seen in male and female rats at doses up to 600 mg/kg/day which resulted in 3-fold exposure above the exposure at the recommended human dose.