THIS MEDICATION MAY CAUSE HARM TO YOUR BABY:
Although human data is limited, tipranavir has not been associated with birth defects and can prevent viral transmission of HIV to the developing baby. Tipranavir should only be used by pregnant women who have clear indications for antiretroviral therapy, but may not be considered first line therapy during pregnancy. Breastfeeding is generally not recommended in HIV positive women.
What is tipranavir?
Tipranavir is an antiretroviral medication known as a protease inhibitor.
What is tipranavir used to treat?
Tipranavir is an antiretroviral medication used to treat HIV type I infection (HIV-1) in individuals who have taken other HIV medications or who are resistant to other protease inhibitors. Tipranavir is typically combined with another antiretroviral medication, ritonavir, for treatment of HIV-1.
How does tipranavir work?
Tipranavir inhibits the HIV-1 protease enzyme, preventing viral replication and the spread of HIV within the body.
If I am taking tipranavir, can it harm my baby?
There are limited studies evaluating the safety of tipranavir use in animals or humans. It is not known if the medication crosses the human placenta to reach the developing baby. The Antiretroviral Pregnancy Registry analysed data on pregnant women on antiretroviral therapy who gave birth between 1989 and 2009, finding no increased risk of birth defects. Cases of preterm delivery have been linked to maternal antiretroviral therapy during pregnancy. Most antiretroviral medications, including tipranavir, should be continued in pregnant women with HIV-1 because the benefit to the mother will outweigh the risk to the developing baby. The combination of tipranavir/ritonavir is not a first line medication in pregnant women who have never been on antiretroviral therapy before becoming pregnant.
If I am taking tipranavir and become pregnant, what should I do?
HIV positive women who want to conceive should discuss this with their doctor before becoming pregnant. It is important to be in good health and on antiretroviral therapy that has decreased your viral load before pregnancy.
Women who become pregnant while taking antiretroviral therapy should continue therapy to prevent transmission of the virus to the developing baby. Continuous monitoring for adverse effects such as maternal increases in blood sugar should be recommended throughout pregnancy. Women who are HIV positive and pregnant and who are not on antiretroviral therapy for their health should receive antiretroviral therapy with three different medications to prevent transmission to the developing baby.
If I am taking tipranavir, can I safely breastfeed my baby?
It is unknown if tipranavir is excreted into the breast milk. In most developed countries, breastfeeding is not recommended in women with HIV because of the risk of spreading the virus to an infant through breastfeeding. In poorly developed countries, HIV positive mothers are more likely to continue breastfeeding their infants, with the infant receiving preventive antiretroviral therapy. The Centers for Disease Control and Prevention recommends not breastfeeding if you are an HIV positive women on antiretroviral therapy.
If I am taking tipranavir, will it be more difficult to get pregnant?
No information is available on tipranavir use and effects on fertility.
If I am taking tipranavir, what should I know?
Tipranavir antiretroviral therapy is recommended in pregnant women with HIV-1 to prevent viral transmission to the developing baby.There is limited information on the use of tipranavir during pregnancy, but available studies have not identified an increased risk of birth defects. Tipranavir/ritonavir combination therapy is not first line antiretroviral therapy in pregnant women. HIV positive women on tipranavir therapy should not breastfeed.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of protease inhibitors during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about HIV here. Additional information can also be found in the resources below.
For more information about tipranavir during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
U.S. Food and Drug Administration: Aptivus Prescribing Information