Medical Oncologist
Alectinib: fertility and pregnancy
Fertility, Pregnancy and Contraception — on Alectinib
Alectinib can harm a developing baby, and both female and male patients are required to use effective contraception. Knowing the exact timeframes — and what counts as effective — helps you make informed decisions before and during treatment.
Medically reviewed by Dr. Bharati Devi Gorantla, Medical Oncologist, MBBS · MD · DM (Adyar, Chennai) · ECMO · MRCP SCE (UK) · Last reviewed August 2026
- Contraception required for both sexes — Female and male patients must use effective contraception during treatment and for three months after the last dose.
- Pregnancy test before starting — Women of childbearing potential must have a negative pregnancy test before their first dose.
- Fertility can be affected — If you want children in the future, ask about egg, embryo, or sperm banking before your first dose.
- Breastfeeding must stop — Avoid breastfeeding during treatment and for one week after your last dose.
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Alectinib can harm a developing baby. Both women and men taking alectinib must use effective contraception during treatment and for three months after the last dose. Pregnancy testing is required before starting. If you are planning a family, tell your oncologist before treatment begins.
Can I get pregnant while taking alectinib?
Pregnancy is not safe during alectinib treatment. The drug can cause fetal harm based on its mechanism of action and on animal studies conducted before its approval, and pregnancy must be avoided for the full duration of treatment.
If you are a woman who could become pregnant, you must use highly effective contraception from before your first dose and continue for three months after your last dose. If you are a man whose partner could become pregnant, the same three-month window after your last dose applies to you.
A pregnancy test is required before starting. If you think you may already be pregnant, tell your team before your first dose — not after.
What are the contraception requirements for female and male patients?
| Requirement | Female patients | Male patients |
|---|---|---|
| Contraception during treatment | Required — highly effective method, not condoms alone | Required — to protect a partner who could become pregnant |
| Contraception after last dose | Continue for 3 months after stopping alectinib | Continue for 3 months after stopping alectinib |
| Pregnancy test | Required before your first dose; repeat if symptoms suggest pregnancy | Not required |
| Breastfeeding | Avoid during treatment and for 1 week after your last dose | Not applicable |
| Fertility preservation to discuss | Egg or embryo banking before starting | Sperm banking before starting |
| If pregnancy occurs | Call your oncology team the same day | Call your oncology team the same day if your partner becomes pregnant |
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What to do before and during treatment
- Tell your oncologist if you are pregnant, think you may be pregnant, or are planning a pregnancy — before your first dose.
- Have a pregnancy test before your first dose if you are a woman who could become pregnant.
- Choose a highly effective contraception method before starting — condoms alone are not considered highly effective. Discuss your options with your team.
- If you want children after treatment, ask for a fertility specialist referral before your first dose, not after.
- Tell your partner about the contraception requirement — the three-month window after your last dose applies to male patients too.
- Stop breastfeeding before starting alectinib.
- If a pregnancy occurs during treatment, contact your oncology team on the same day.
What if I want to have children after finishing alectinib?
This is a decision worth raising before treatment begins, not at the end. Alectinib may affect fertility, and the time to bank eggs, embryos, or sperm is before your first dose.
Human data on whether and how quickly fertility returns after alectinib is limited. Animal studies suggest the drug may affect fertility, but the picture in people is not yet clear. Banking first removes the uncertainty.
Your oncologist can refer you to a fertility specialist before starting. Ask early — some fertility procedures take several weeks, and you may not want to delay treatment while you wait.
Did you know?
Pregnant women were excluded from the clinical trials that led to alectinib's approval, so there is no direct human pregnancy safety data. The three-month contraception window after your last dose reflects the time the drug takes to clear from the body — it is not an arbitrary precaution.
If you have questions about the specific timing for your situation, your oncology team can calculate the window from your actual last dose.
Source: FDA prescribing information, Alecensa (alectinib), Genentech
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Common questions
Frequently asked questions
What contraception is actually effective enough while on alectinib?
The prescribing information requires a highly effective method — meaning one with a failure rate below 1% per year with consistent use. Examples include an intrauterine device, a hormonal implant, or sterilisation. Condoms alone are not considered highly effective for this purpose. Your oncologist or gynecologist can help you choose the right method before treatment starts, particularly if you are concerned about interactions with any other medicines you are taking.
My partner is pregnant. Can I still take alectinib?
If your partner is already pregnant, you should use effective contraception throughout your treatment and for three months after your last dose to avoid any potential exposure through semen. Tell your oncology team about the pregnancy. The decision to continue or adjust treatment is your oncologist's, based on the urgency of your cancer treatment, and that conversation should happen promptly rather than being put off.
Can I stop alectinib temporarily to try for a pregnancy?
This is a question only your oncologist can answer for your specific situation. Alectinib controls ALK-positive lung cancer, and pausing it carries a real risk of disease progression. For some patients that risk may be acceptable; for others it is not. If family planning matters to you, raise it before treatment starts rather than mid-treatment, so you and your oncologist have more options available and more time to think through them carefully.
Will alectinib affect my fertility permanently?
Animal data suggests alectinib may impair fertility, but human data on this is limited, and whether fertility returns after stopping is not clearly established. This is exactly why fertility specialists recommend banking eggs, embryos, or sperm before starting treatment rather than waiting to find out. Your oncology team can refer you before your first dose. Do not wait until you have finished treatment to ask — by then, the window may have passed.
I am breastfeeding — do I have to stop?
Yes. You should not breastfeed during treatment or for one week after your last dose. It is not known whether alectinib passes into breast milk, but given its potential to harm development, the prescribing information advises avoiding any exposure. If you have a newborn or are currently nursing, discuss feeding alternatives with your team before starting alectinib so that a plan is in place before your first dose.
What happens if I accidentally become pregnant while on alectinib?
Contact your oncology team on the same day you find out. Do not stop alectinib without speaking to your team first — how to proceed involves weighing the risk to the pregnancy against the risk to your health from pausing treatment, and that conversation needs to happen immediately. Your oncologist will likely involve a maternal-fetal medicine specialist. The key thing is not to wait — call the same day.