Isentress

THE SAFETY OF RALTEGAVIR (ISENTRESS) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

This medication is considered to have a low risk when used during pregnancy:

Although human data is limited, raltegavir can be used in pregnant women who have clear indications for antiretroviral therapy. Breastfeeding is generally not recommended in HIV positive women.

What is raltegavir?

Raltegavir is an antiretroviral medication used to treat human immunodeficiency virus (HIV). The medication is often used in combination with other antiretroviral medications for HIV treatment.

What is raltegavir used to treat?

Raltegavir is a prescription medication used to treat HIV type I infections in adults and children.

How does raltegavir work?

Raltegavir is a type of antiretroviral medication known as a integrase inhibitor. Raltegavir prevents viral DNA from being incorporated into human DNA, which prevents replication of the HIV virus in the body. 

If I am taking raltegavir, can it harm my baby?

Animal and human studies have not found an increased risk of birth defects or growth problems in the baby with raltegavir use during pregnancy. Some studies report a possible increase in risk of preterm delivery with raltegavir use during pregnancy. The Antiretroviral Pregnancy Registry has not identified any link between raltegavir use during pregnancy and an increased risk of birth defects. If the medication is indicated in the mother, it should not be withheld due to pregnancy. The benefit of raltegavir to the mother is expected to outweigh any negative effects on the developing baby. Raltegavir is expected to cross the human placenta to reach the baby. The Antiretroviral Pregnancy Registry analysed data on pregnant women taking antiretroviral therapy that gave birth between 1989 and 2009, finding no increased risk of birth defects. Raltegavir is the preferred integrase inhibitor for use in pregnancy.

If I am taking raltegavir and become pregnant, what should I do?

HIV positive women who want to conceive should discuss with their doctor before conceiving. 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 increased liver enzymes is 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 baby. 

If I am taking raltegavir, can I safely breastfeed my baby?

Raltegavir is expected to pass into human 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 even if you are on antiretroviral therapy.

If I am taking raltegavir, will it be more difficult to get pregnant?

Animal studies have found that high doses of raltegavir do not negatively affect fertility.

If I am taking raltegavir, what should I know?

Raltegavir antiretroviral therapy is safe to use in pregnant women with HIV requiring therapy. The medication can prevent transmission of HIV from mother to child. Breastfeeding is not recommended for women with HIV.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of integrase inhibitors during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert report about HIV here and reports about the individual medications used to treat HIV here.   Additional information can also be found in the resources below. 

For more information about raltegavir during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Merck: Isentress Prescribing Information

Read the whole report
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.