Pregnancy & Lactation : הריון/הנקה

4.6   Pregnancy and lactation

Pregnancy:
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 (see section 5.3) as well as the clinical experience in pregnant women should be taken into account. In the present case, the use in pregnant women of zidovudine, with subsequent treatment of the newborn infants, has been shown to reduce the rate of maternal-foetal transmission of HIV.


A large amount of data on pregnant women (more than 3000 outcomes from first trimester and more than 3000 outcomes from second and third trimester exposure) indicate no malformative toxicity. Retrovir can be used during pregnancy if clinically needed. The malformative risk is unlikely in humans based on the mentioned large amount of data.

Zidovudine has been associated with reproductive toxicity findings in animal studies (see section 5.3). The active ingredients of Retrovir may inhibit cellular DNA replication and zidovudine has been shown to be a transplacental caricinogen in one animal study. The clinical relevance of these findings is unknown. Placental transfer of zidovudine has been shown to occur in humans.

Mitochondrial dysfunction: nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4).

Fertility:
Zidovudine did not impair male or female fertility in rats given oral doses of up to 450 mg/kg/day. There are no data on the effect of Retrovir on human female fertility. In men,
Retrovir has not been shown to affect sperm count, morphology or motility.

Breast-feeding:
After administration of a single dose of 200 mg zidovudine to HIV-infected women, the mean concentration of zidovudine was similar in human milk and serum. It is recommended that women living with HIV do not breast-feed their infants in order to avoid transmission of HIV.