Important safety information
Before you take GILOTRIF, tell your doctor if you:
have kidney or liver problems
have lung or breathing problems other than lung cancer
have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact
have heart problems
have any other medical conditions
are pregnant or plan to become pregnant. GILOTRIF can harm your unborn baby. You should not become
pregnant while taking GILOTRIF.
Women who are able to become pregnant should use effective birth control during treatment
GILOTRIF and for at least 2 weeks after your last dose
of GILOTRIF. Talk to your doctor about birth control methods that may be right for you.
Tell your doctor right away if you become pregnant or think you are pregnant while taking
are breastfeeding or plan to breastfeed. It is not known if GILOTRIF passes into your breast milk.
Do not breastfeed while taking GILOTRIF and for 2 weeks after
your last dose of GILOTRIF. Talk to your doctor about the best way to feed your baby if you take GILOTRIF.
Tell your doctor about all the medicines you take, including prescription and over-the-counter
vitamins, and herbal supplements. GILOTRIF may affect the way other medicines work, and other medicines
may affect the way GILOTRIF works.
What to avoid while taking GILOTRIF
Limit your time in the sun. GILOTRIF can make your skin sensitive to the sun. You could get or have
worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that
cover your skin while you
are taking GILOTRIF if you have to be in sunlight.
GILOTRIF may cause serious side effects, including:
The most common side effects of GILOTRIF include diarrhea, rash, mouth sores, nail inflammation,
dry skin, acne, decreased appetite, nausea, vomiting, itching.
GILOTRIF may cause decreased fertility in females and males. Talk to your doctor if you have concerns
about your fertility.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of GILOTRIF. For more information, ask your doctor or
Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
or call 1-800-FDA-1088.
What is GILOTRIF?
GILOTRIF is a prescription medicine that is used to treat people with non-small cell lung cancer
- has certain (non-resistant) abnormal epidermal growth factor receptor (EGFR) gene(s). Your
healthcare provider will perform a test to make sure that GILOTRIF is right for you.
has spread to other parts of the body (metastatic), and
has not been previously treated for metastatic lung cancer
It is not known if GILOTRIF is safe and effective in treating people with lung cancer that has resistant
abnormal EGFR genes.
is used to treat people with squamous cell lung cancer that:
has spread to other parts of the body, and
has been previously treated with chemotherapy that contains platinum.
It is not known if GILOTRIF is safe and effective in children.
Please see Prescribing Information
and Patient Information.
GF CONS ISI 01.12.18