Medical Oncologist
Fertility and safety on Tagrisso
Fertility, Pregnancy and Contraception — on Osimertinib
Osimertinib is harmful to a developing baby. If you are of childbearing age — or your partner is — there are specific contraception requirements and washout periods your team needs to discuss with you before treatment starts.
Medically reviewed by Dr. C. Raghavendra Reddy, Medical Oncologist, MBBS (Gold Medal) · DNB · DM (Medical Oncology, Gold Medal) · Last reviewed August 2026
- Pregnancy must be actively prevented — Osimertinib causes harm to a developing baby and cannot be taken safely during pregnancy.
- Timelines differ for women and men — The required contraception period after your last dose is different depending on whether you are the person taking the drug or a male partner.
- Fertility preservation is time-sensitive — If having children matters to you, the conversation with your team should happen before your first dose, not after.
- Your team needs to know your plans — Decisions about contraception, fertility preservation and family timing are made together with your oncologist — not managed alone.
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Osimertinib is harmful to a developing baby and must not be taken during pregnancy. Women must use effective contraception during treatment and for two months after the last dose. Men whose partners could become pregnant must use contraception during treatment and for four months after the last dose.
Why is osimertinib dangerous in pregnancy?
Osimertinib works by blocking signals that cancer cells use to grow. Those same signals play a role in normal fetal development, which is why the drug carries a specific and established risk to a developing baby.
Animal studies conducted as part of the regulatory review showed that osimertinib caused fetal harm at exposures similar to those used in people. There are no human pregnancy studies — a clinical trial would not be ethical.
Because the risk is understood and not hypothetical, the prescribing information reviewed by CDSCO, the US FDA and the EMA requires active contraception, not just general advice to avoid pregnancy.
What you need to do before and during treatment
- Tell your oncologist before the first dose if you are pregnant, may be pregnant, or are trying to conceive.
- If you are a woman of childbearing potential, confirm your contraception method with your team before starting.
- If you are a man whose partner could become pregnant, discuss contraception for both of you.
- Do not stop contraception on your last day of treatment — the washout period begins from that day and continues after.
- If fertility preservation matters to you, ask for a specialist referral at diagnosis, not after treatment starts.
- Tell your team immediately if your contraception situation changes at any point during treatment.
Contraception and washout periods: women versus men
| Requirement | Women of childbearing potential | Men with partners who could become pregnant |
|---|---|---|
| During treatment | Effective contraception required throughout | Effective contraception required throughout |
| Washout period after last dose | Two months | Four months |
| Why the periods differ | Based on drug clearance from the body | Sperm require longer to fully clear drug exposure |
| Breastfeeding | Not recommended during treatment or for two weeks after the last dose | Not applicable |
| Pregnancy test before starting | Recommended to confirm not pregnant | Not applicable |
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What if having children is part of your plan?
A cancer diagnosis does not end the possibility of having children, but osimertinib requires planning if that is something you want.
Fertility preservation — egg freezing, embryo freezing, or sperm banking — is most effective when arranged before treatment begins. Osimertinib may affect fertility during treatment, and the window before you start is the right time to act.
A referral to a reproductive specialist alongside your oncology care is reasonable to ask for at diagnosis. In most cases this does not delay starting treatment.
Questions about family planning on osimertinib
Can I use hormonal contraception while on osimertinib?
The prescribing information does not exclude hormonal methods, but your oncologist and gynaecologist should agree on the specific method before you start. Some targeted therapies affect the liver enzymes that process hormonal contraceptives, which can reduce their effectiveness. The safest approach is to have both teams confirm the method is appropriate for you rather than assuming any contraceptive you were using before treatment will remain reliable during it.
What happens if I become pregnant while taking osimertinib?
Tell your oncology team immediately. The decision about how to proceed is a serious one that involves your oncologist, an obstetrician experienced in cancer in pregnancy, and you. There is no single answer that applies to everyone, and the conversation needs to happen urgently given the established risk to the pregnancy. This is not a situation to navigate alone or to delay reporting while hoping the problem resolves.
How long after stopping osimertinib can I try to conceive?
The prescribing information specifies two months after the last dose for women and four months for men before trying to conceive. These are the periods required for the drug to clear adequately. However, the decision to try also depends on whether your cancer remains stable — your oncologist needs to be part of that conversation. The washout period is a minimum based on drug clearance, not a standalone green light to proceed without your team's input.
Is it safe to breastfeed while on osimertinib?
Breastfeeding is not recommended while taking osimertinib or for two weeks after the last dose. It is not known whether osimertinib or its breakdown products pass into breast milk in humans, but based on how the drug behaves in the body, a risk to a breastfed baby cannot be excluded. Your team will advise on feeding alternatives for this period.
Will osimertinib affect my fertility permanently?
We do not yet have definitive long-term human data on fertility after osimertinib. Based on its mechanism, it may affect fertility during treatment, and some effects may persist for a period after stopping. This is one of the reasons fertility preservation before starting treatment is worth discussing early, when the most options are available to you. A reproductive specialist can assess your individual situation and advise on what steps make sense.
Can I have IVF while on osimertinib?
IVF should not be attempted while you are taking osimertinib, because a resulting pregnancy would carry the same fetal risk as any pregnancy during treatment. If IVF is part of your family plan, the timing needs to be agreed between your oncologist and reproductive specialist — ideally before treatment starts, or after it finishes and the washout period is complete. Do not proceed with fertility treatment without both teams involved in the decision.
Did you know?
Egg and embryo freezing success rates have improved substantially, and fertility preservation is now a realistic option for many people facing cancer treatment.
The critical factor is acting before treatment begins — not waiting to see whether fertility is affected.
Source: ASCO Guidelines on Fertility Preservation in Patients with Cancer
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Common questions
Frequently asked questions
How long do I need to use contraception on osimertinib?
You need contraception throughout treatment and for a defined period after your last dose. For women of childbearing potential, that period is two months after the last dose. For men whose partners could become pregnant, it is four months. These timelines come from the prescribing information reviewed by regulatory bodies including CDSCO and the US FDA. The washout period starts on the day of your last dose — do not stop contraception that day.
Can I still have children after finishing osimertinib?
Pregnancy after the washout period is not excluded by the prescribing information, but the decision depends on more than drug clearance. Your oncologist will want to assess that your cancer is stable or in remission before you try to conceive. Some people do go on to have healthy pregnancies after targeted therapy. This is a conversation to have with your oncologist and a reproductive specialist together, and the answer will be specific to your situation.
Should I freeze eggs or embryos before starting osimertinib?
If having children matters to you, fertility preservation is worth discussing before your first dose. Osimertinib may affect ovarian function or egg quality during treatment, and egg or embryo freezing is most effective before any cancer treatment begins. Ask for a referral to a reproductive specialist at diagnosis — in most cases this does not delay starting treatment, but it requires acting quickly.
My husband is on osimertinib. Do we need contraception?
Yes. Men taking osimertinib need effective contraception if their partner could become pregnant — during treatment and for four months after the last dose. The longer washout period for men, compared with two months for women, reflects the time needed for sperm to fully clear drug exposure. This applies regardless of partner age or cycle regularity and is a requirement, not an optional precaution.
What contraception is considered effective on osimertinib?
The prescribing information requires effective contraception but does not specify a single method — this is a conversation for your oncologist and the clinician managing your contraception. Some hormonal methods may be less reliable if osimertinib affects the liver enzymes that process them. Barrier methods used consistently are not affected in this way. Have your team confirm the method you choose before starting treatment rather than assuming your current method is sufficient.
What should I tell my oncologist at my next appointment?
Tell them whether you are using contraception and which method, whether you or your partner could be pregnant now, and whether having children is something you want in the future. If fertility preservation is important to you, ask for a referral to a reproductive specialist and ask when that appointment needs to happen relative to starting treatment. Writing these questions down before your appointment helps — this is a lot to remember when you are already processing a diagnosis.