Pregnancy Risk Factor

C

Pregnancy Implications

Teratogenic effects were not observed in animal reproduction studies; fetotoxity was observed with some doses. It is not known if tipranavir crosses the human placenta. Pregnancy and protease inhibitors are both associated with an increased risk of hyperglycemia. Glucose levels should be closely monitored. Women receiving estrogen (as hormonal contraception or replacement therapy) have an increased incidence of rash. Alternative forms of contraception may be needed. The Perinatal HIV Guidelines Working Group notes there is insufficient data to recommend use during pregnancy; however, if used, tipranavir must be given with low-dose ritonavir boosting. Health professionals are encouraged to contact the antiretroviral pregnancy registry to monitor outcomes of pregnant women exposed to antiretroviral medications (1-800-258-4263 or www.APRegistry.com).

Lactation

Excretion in breast milk unknown/contraindicated

Breast-Feeding Considerations

In infants born to mothers who are HIV positive, HAART while breast-feeding may decrease postnatal infection. However, maternal or infant antiretroviral therapy does not completely eliminate the risk of postnatal HIV transmission.

In the United States where formula is accessible, affordable, safe, and sustainable, complete avoidance of breast-feeding by HIV-infected women is recommended to decrease potential transmission of HIV.