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
General information
It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.
For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.
It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.
If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.
If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.
Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.