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Fertility and safety

Fertility, Pregnancy and Contraception — on Gefitinib

Gefitinib can harm a developing baby at any stage of pregnancy. You need effective contraception from the day you start treatment, and for two weeks after your last dose — whether you are the patient or a man whose partner could become pregnant.

Medically reviewed by Dr. T. Raghavender Reddy, Medical Oncologist, MBBS · DM (Medical Oncology) · MD (Radiation Oncology) · Last reviewed August 2026

  • Contraception is required — Effective contraception must be used throughout treatment and for two weeks after stopping, by both women taking gefitinib and men whose partners could conceive.
  • Two-week washout period — You must wait at least two weeks after your last dose before trying to conceive. Your oncologist may advise longer depending on your recovery.
  • Fertility may be affected — Gefitinib can affect fertility in both women and men. Ask about preservation options — egg, embryo or sperm freezing — before treatment starts.
  • Breastfeeding is not recommended — You should not breastfeed during treatment or for two weeks after your last dose.
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Gefitinib can harm a developing baby and must not be taken during pregnancy. The prescribing information for gefitinib requires effective contraception throughout treatment and for two weeks after your last dose. If you are planning a family or are already pregnant, tell your oncologist before you start — there are steps to protect your fertility.

Who needs contraception on gefitinib — and for how long?

Women taking gefitinibMen taking gefitinib (partner could become pregnant)
Contraception required during treatment?Yes — from day oneYes — from day one
How long after the last dose?Two weeksTwo weeks
Pregnancy test before starting?Discuss with your oncologistNot applicable
Breastfeeding during or after treatment?Not recommended during treatment or for two weeks after the last doseNot applicable
Fertility may be affected?Yes — ask about egg or embryo freezing before you startYes — ask about sperm banking before you start

What should you do before starting gefitinib if you want children?

  • Tell your oncologist your family plans before your first dose — not after
  • Ask about fertility preservation options such as egg, embryo or sperm freezing before treatment begins
  • Arrange reliable contraception to use from day one of treatment
  • If you are already pregnant, tell your oncologist immediately — do not wait for your next scheduled appointment
  • Ask which contraception method is most appropriate for your specific situation and other medicines
  • Remember the two-week washout: wait at least this long after your last dose before trying to conceive

Can you try for a baby after finishing gefitinib?

Yes, but not immediately. The prescribing information for gefitinib requires you to wait at least two weeks after your last dose before trying to conceive — for both women and men.

Two weeks is based on how long the drug takes to clear from your body. Your oncologist may advise waiting longer depending on your overall recovery and health at the time you stop.

Fertility can be affected by the cancer itself, by treatment, and by the time treatment takes. This is why raising the question before you start is almost always better than raising it afterwards.

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What if you find out you are pregnant while taking gefitinib?

Contact your oncologist the same day. This is not a situation to manage on your own or to wait until your next appointment.

Gefitinib carries a fetal harm warning based on its mechanism of action and animal studies. Your team will need to discuss what happens next urgently — whether treatment continues, pauses or changes to an alternative.

Unplanned pregnancies happen even with contraception. This is not a reason for blame. The right response is prompt contact with your team.

Did you know?

EGFR signalling plays a role in normal fetal development across multiple stages of pregnancy — not only the first trimester. Gefitinib works by blocking EGFR, which is why the fetal harm warning applies throughout pregnancy, and why the contraception requirement begins on day one of treatment.

This is a class effect shared by EGFR-targeting drugs, not a quirk unique to gefitinib.

Source: Gefitinib (Iressa) prescribing information — EGFR inhibitor fetal harm class effect

Questions families ask about gefitinib and fertility

Which contraception methods are suitable while taking gefitinib?

The prescribing information specifies effective contraception but does not mandate a single method. Hormonal methods — the pill, implant or injection — and intrauterine devices are generally considered effective. Barrier methods alone are typically regarded as less reliable. The right choice depends on your medical history and any other medicines you are taking, since some conditions that coincide with cancer treatment can affect which options are appropriate for you. Ask your oncologist or a gynaecologist to advise on what suits your specific situation.

Does gefitinib cause permanent infertility?

Animal studies suggest gefitinib can affect fertility in both women and men, though whether this translates to lasting infertility in all humans is not yet fully established. What is clear is that the risk exists. Fertility preservation before treatment — egg, embryo or sperm freezing — is the only reliable way to protect future options with certainty. Ask your oncologist to refer you to a fertility specialist before your first dose if having children is something you want. This conversation is easier to have before treatment starts than after.

Can I breastfeed while taking gefitinib?

No. You should not breastfeed during treatment or for two weeks after your last dose. There is currently no data on whether gefitinib passes into human breast milk, and because of the potential for serious effects on a breastfed baby, the guidance is to avoid breastfeeding entirely during this period. If you have recently given birth and want to discuss feeding options, tell your oncologist — they can refer you to appropriate support while you are on treatment.

I am a man on gefitinib. Does the contraception requirement apply to me too?

Yes. The prescribing information for gefitinib requires men whose partners could become pregnant to use effective contraception during treatment and for two weeks after the last dose. The drug may be present in semen, and its potential effects on a developing baby are not limited to exposure through the mother. Gefitinib may also affect sperm quality. If you want children in the future, ask about sperm banking before treatment starts — that option is not affected by what happens after treatment begins.

What does the two-week washout period actually mean in practice?

A washout period is the time needed for a drug to clear from your body after you stop taking it. For gefitinib, the prescribing information sets a minimum of two weeks after your last dose before you try to conceive. This is based on the drug's half-life — the time it takes for half the amount in your bloodstream to be eliminated. Your oncologist may advise waiting longer if there are other clinical reasons to do so. Do not attempt to conceive before the washout period is complete, even if you feel well and have no side effects.

I am already pregnant and have just been told I need gefitinib. What happens now?

This is a difficult situation and there is no single standard answer. Your oncologist will need to weigh the risk to the pregnancy against the urgency of treating your cancer. That balance depends on how far along you are, how aggressive the cancer is, and whether alternative treatments with a lower fetal risk profile exist. Some women in this situation delay treatment, some receive alternative drugs, and some continue after detailed counselling. This decision should involve a multidisciplinary team. Ask for that discussion as early as possible — ideally the same day you receive the diagnosis.

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Common questions

Frequently asked questions

How long do I need contraception after my last dose of gefitinib?

At least two weeks after your last dose — this applies to both women taking gefitinib and men whose partners could become pregnant. The two-week figure comes from how long gefitinib takes to clear from the body. Your oncologist may advise waiting longer before trying to conceive, depending on your recovery and overall health at that point.

Will gefitinib affect my ability to have children in the future?

It may. Animal studies show gefitinib can affect fertility in both women and men, though the full picture in humans is not yet established. The most effective protective step is to discuss fertility preservation — egg, embryo or sperm freezing — before you start treatment. Once treatment has begun, these options become harder to access. Tell your oncologist your intentions before your first dose so you can be referred promptly.

Is there any point in pregnancy when gefitinib is considered safe?

No established safe window has been identified. Gefitinib carries a fetal harm warning that applies across pregnancy, not only in the first trimester, because EGFR signalling is involved in organ development at multiple stages. If you are pregnant and need urgent cancer treatment, your oncologist will discuss all available options — but gefitinib is not considered safe at any stage of pregnancy.

What should I do if I have a contraception failure while on gefitinib?

Contact your oncologist and your gynaecologist promptly. Emergency contraception may be appropriate, but which option is suitable depends on your medical history and any other medicines you are taking. Timing matters for emergency contraception, so do not wait to raise it. Your oncologist can also advise on next steps in monitoring and what to watch for.

Can CION refer me to a fertility specialist before I start gefitinib?

Yes. Your oncologist at CION can refer you to a fertility specialist before treatment begins if you want to discuss preservation options such as egg, embryo or sperm freezing. Raising this at your first appointment — or before, if you have been given time to prepare — gives you the best chance of completing preservation steps before treatment starts. Ask specifically at your first visit so the referral is arranged without delay.

Is gefitinib given as a drip or tablet, and does the form affect these precautions?

Gefitinib is taken as a daily oral tablet, not a drip or infusion. The form of the drug does not change the contraception or fertility precautions — they apply equally regardless of how the drug is taken. The two-week washout period after your last tablet, the requirement for effective contraception throughout, and the breastfeeding restriction all remain in place as described.

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