Fertility, Pregnancy and Contraception — on Imatinib
Imatinib can harm a developing baby, so effective contraception is required throughout treatment for anyone who could become pregnant. If you are thinking about starting a family, this decision needs your oncologist involved from the beginning.
Medically reviewed by Dr. T. Raghavender Reddy, Medical Oncologist, MBBS · DM (Medical Oncology) · MD (Radiation Oncology) · Last reviewed August 2026
- Contraception is not optional — Anyone who can become pregnant must use effective contraception throughout imatinib treatment.
- A washout period is needed — After stopping imatinib, time must pass before attempting conception — your oncologist sets the duration.
- Men need to plan too — Imatinib may affect sperm. Sperm banking before starting treatment is worth discussing.
- Breastfeeding is not safe — Imatinib passes into breast milk. It is not recommended while on this medicine.
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Imatinib is harmful to a developing baby. Effective contraception is required throughout treatment for all women of childbearing potential — not skippable. If you want to start a family, talk to your oncologist before changing anything. Stopping imatinib needs to be planned, with a washout period before trying to conceive.
Why does imatinib require contraception?
Imatinib has caused birth defects in animal studies, and there are case reports of fetal harm in humans when it was taken in the first trimester.
Because of this, the European Medicines Agency classifies imatinib as contraindicated in pregnancy unless there is no safer alternative.
Contraception must be used throughout treatment — not just in the early months, and not just until your disease is stable. The risk exists for as long as you are taking the medicine.
What contraception do you need while on imatinib?
- Start before your first doseContraception should be in place before imatinib begins, not after.
- Use a reliable method — not barrier aloneBarrier methods alone are not considered sufficient. Discuss hormonal contraception, an IUD, or another reliable option with your gynaecologist.
- Tell your gynaecologist you are on imatinibSome hormonal contraceptives interact with imatinib. Your gynaecologist needs to know your full medicine list.
- Continue through the washout period after stoppingContraception should continue until your oncologist confirms the drug has cleared from your body.
- If you think you are pregnant, call your team the same dayAn accidental pregnancy on imatinib needs urgent oncology review, not a wait-and-see approach.
What are your options if you want to start a family?
Some people with CML who achieve a sustained deep molecular response may be considered for a supervised period off imatinib — called treatment-free remission — during which a pregnancy can be planned.
This is not suitable for everyone. ELN guidelines describe specific criteria, including several years of sustained deep response, that your oncologist will assess before considering it.
A washout period of several weeks is recommended after stopping imatinib before attempting conception, to allow the drug and its active metabolite to clear. Your oncologist will give you the exact duration based on your situation.
Stopping imatinib without a plan risks disease relapse. The path to a planned pregnancy runs through your oncologist, not around them.
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How does imatinib affect fertility for women and men?
| Women | Men | |
|---|---|---|
| Contraception required | Yes — throughout treatment and washout period | Use barrier contraception during treatment; discuss specifics with your oncologist |
| Fertility preservation | Egg or embryo freezing before starting imatinib is an option to discuss | Sperm banking before the first dose is recommended if future fatherhood is planned |
| Planning a pregnancy | Requires sustained deep remission; treatment-free remission may be considered under ELN criteria | Limited human data; discuss with your oncologist before trying to conceive |
| Breastfeeding | Not recommended — imatinib is present in breast milk | Not applicable |
| Who to speak to first | Your oncologist and a gynaecologist experienced in cancer care | Your oncologist before making any change to treatment |
More questions about imatinib and pregnancy
How long is the washout period before trying to conceive?
The exact duration depends on how long you have been on imatinib, your molecular response, and your individual situation. Imatinib and its active metabolite clear pharmacologically within days, but ELN guidance recommends a supervised period off treatment — often several weeks — with close molecular monitoring throughout. Your oncologist will give you a specific plan. Do not stop imatinib and start trying without that conversation first.
What happens if I become pregnant accidentally while on imatinib?
Call your oncology team the same day. An accidental pregnancy on imatinib needs urgent review — not because all outcomes are necessarily bad, but because the decision about what to do next is complex and time-sensitive. Your oncologist will assess the risks based on how far along the pregnancy is and how well your disease is controlled. This conversation is confidential and your team will support you without judgement, whatever you decide.
Can imatinib cause permanent infertility?
There is no clear evidence from human studies that imatinib causes permanent infertility in women. In men, animal studies have shown effects on sperm, and there are limited human reports, but the picture is not definitive. The more important practical step is fertility preservation — egg freezing for women, sperm banking for men — before you start, when you still have the option. Ask your oncologist to refer you to a fertility specialist if you want to explore this.
Are there safer alternatives to imatinib during pregnancy?
This is a decision your oncologist makes based on your disease, your response to treatment, and the stage of pregnancy. Some patients with CML in very deep remission are managed through pregnancy with close monitoring and without a TKI for part of the pregnancy. Where treatment is needed, the choice of which medicine carries the least risk is made by the oncologist in consultation with a maternal-fetal medicine specialist. There is no single right answer — the decision is individual.
Can I breastfeed while on imatinib?
No. Imatinib is present in breast milk, and the EMA recommends that women on imatinib should not breastfeed. This applies for the duration of treatment and through the washout period after stopping. Formula feeding from birth is the safe approach if you are continuing imatinib. Discuss this with your oncologist and paediatrician before your baby arrives so there is a clear plan in place.
What should men taking imatinib know about fertility?
Imatinib may affect sperm quality, though the human evidence is limited. If you are a man of reproductive age starting imatinib and you want children in the future, sperm banking before your first dose is worth discussing with your oncologist. It is straightforward, it keeps your options open, and it is much easier to arrange before treatment than during it. If you are already on imatinib and now planning a family, ask your oncologist whether any precautions are needed before you try to conceive.
Did you know?
Many people with CML now live for decades on imatinib. Family planning has become one of the most common and important conversations in CML care as a result.
ELN guidelines now include a dedicated section on treatment-free remission and pregnancy planning — a sign of how central this question has become.
Source: European LeukemiaNet (ELN) CML Guidelines 2020
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Frequently asked questions
Is it safe to take imatinib in the first trimester?
No. Imatinib is associated with fetal harm, and this risk is highest in the first trimester when organs are forming. This is why contraception is mandatory from the first dose. If you have already been exposed to imatinib in early pregnancy, speak to your oncologist and a maternal-fetal medicine specialist immediately so that appropriate counselling and monitoring can be arranged.
Can I stop imatinib myself if I want to get pregnant?
No — stopping imatinib on your own, without your oncologist's involvement, risks your CML coming back. Treatment-free remission is only safe under close molecular monitoring and is only considered for people who have met specific ELN criteria over several years of treatment. The path to a planned pregnancy on imatinib runs through your oncologist, not around them.
What contraception is suitable while on imatinib?
Barrier methods alone are generally not considered sufficient. Hormonal contraception, an IUD, or another reliable method is recommended. However, some hormonal contraceptives interact with imatinib, so your gynaecologist needs to know your full medicine list. Bring everything you are taking to that appointment, including imatinib and any other medicines your oncologist has prescribed.
Does imatinib affect male fertility?
Animal studies have shown effects on sperm, and there are limited reports in men. The human evidence is not definitive, but sperm banking before starting imatinib is a simple, low-risk step that preserves future options. If you are already on treatment and planning to start a family, ask your oncologist whether any precautions are needed before you try to conceive.
What is treatment-free remission and who is eligible?
Treatment-free remission means stopping imatinib under careful supervision after achieving a sustained deep molecular response over several years. It is not suitable for everyone — eligibility is assessed against ELN criteria that your oncologist will explain. For people who want to conceive, it may allow a period off treatment with close monitoring. This is planned in advance; it is not the same as simply stopping the medicine.
Will my oncologist judge me for asking about pregnancy?
No. Fertility and family planning are a legitimate part of your care, and asking about them is not a distraction from your treatment — it is part of it. ELN guidelines specifically address pregnancy planning in CML, which means this conversation is expected and your team will have had it before. If you feel the topic needs more time than a routine appointment allows, ask for a dedicated consultation to discuss it properly.