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Despite limited human data, there is a potential risk of adverse effects on the developing baby with exposure during pregnancy. It is recommended to avoid this medication during pregnancy and breastfeeding unless the benefit to the mother outweighs the risk to the baby.

What is imatinib description?

Imatinib is an anticancer medication known as a tyrosine kinase inhibitor.

What is imatinib used to treat?

Imatinib is a prescription medication used to treat adults and children newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic, blast, or accelerated phase. Imatinib is also used to treat relapsed or nonresponsive Ph+ lymphoblastic leukemia, gastrointestinal stromal tumors, aggressive systemic mastocytosis, dermatofibrosarcoma protuberans, hypereosinophilic syndrome, and myelodysplastic/myeloproliferative disease.

How does imatinib work?

Imatinib prevents tumor growth and tumor-related blood vessel development by inhibiting the tyrosine kinase enzyme, BR-CL, in cancerous cells.

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

Because of the effects of imatinib on blood vessel development, it is recommended to avoid using the drug during pregnancy. If imatinib is indicated to treat leukemia, it should not be withheld due to pregnancy. Animal studies have reported incidences of death of the developing baby and brain defects in the developing baby. Imatinib is expected to cross the human placenta and reach the developing baby. Case reports in women who stopped imatinib early in pregnancy describe the delivery of healthy infants. Other reports note an increased risk of spontaneous abortion and birth defects with imatinib exposure during pregnancy.

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

Imatinib therapy is not recommended during pregnancy. A pregnancy test is performed in women prior to starting imatinib therapy. Women of reproductive age on imatinib therapy should use a reliable type of birth control during therapy and for at least 14 days after discontinuing imatinib. If a woman becomes pregnant while on imatinib, her doctor should discuss the risks associated with medication. European guidelines recommend that imatinib therapy only be used in the second and third trimester for pregnant women with chronic myeloid leukemia.

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

Imatinib is expected to cross into breast milk. The risks and benefits of imatinib therapy should be weighed before using during breastfeeding. It is generally recommended to avoid breastfeeding while on imatinib therapy and for one month after discontinuing imatinib.

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

Animal studies suggest that imatinib, given at doses lower than the maximum human dose, may impact male testicle weight and sperm mobility. Human studies have failed to establish a link between fertility impairment and imatinib exposure [1].

If I am taking imatinib, what should I know?

Although there is limited human data, animal studies suggest a potential risk during pregnancy. It is important to speak with your doctor if you are on imatinib and you become pregnant. You and your doctor can weigh the risks versus benefits of imatinib therapy during pregnancy. It is generally recommended to avoid breastfeeding if you are on this medication.

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

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

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

For more information about imatinib during and after pregnancy, contact (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Novartis: Gleevec Prescribing Information

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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.