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 an ulcer, a tear (perforation) in your stomach or intestine, or diverticular disease (inflammation) in parts of your large intestine
have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
have heart problems
have any other medical conditions
are pregnant or plan to become pregnant. GILOTRIF can harm your unborn baby.
Females who are able to become pregnant should use effective birth control during treatment with
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 during treatment with
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 medicines,
vitamins, and herbal supplements. GILOTRIF may affect the way other medicines work, and other medicines
may affect the way GILOTRIF works. Taking certain medicines with GILOTRIF may increase your risk of
developing a tear (perforation) in your stomach or intestine.
What to avoid while taking GILOTRIF
Limit your time in the sun. GILOTRIF can make your skin sensitive to sunlight. 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 if you have to be in sunlight during treatment with GILOTRIF.
GILOTRIF may cause serious side effects, including:
Diarrhea. Diarrhea is common with GILOTRIF and may sometimes be severe. Severe diarrhea can
cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During
your treatment with GILOTRIF, your doctor should prescribe medicines to treat diarrhea. Take this
medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention
right away if your diarrhea does not go away or becomes severe.
Skin reactions. GILOTRIF can cause redness, rash, and acne. It is important to get treatment for skin
reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells
you to. Get medical attention right away if you develop severe skin reactions such as peeling or
blistering of the skin, or blisters in your mouth.
Lung or breathing problems. GILOTRIF may cause inflammation of the lung that may lead to death.
Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have
any new or worsening lung problems, or any combination of the following symptoms: trouble breathing
or shortness of breath, cough, or fever.
Liver problems. GILOTRIF can cause liver problems that can sometimes lead to death. Tell your
doctor right away if you have any symptoms of a liver problem which may include:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark or brown (tea-colored) urine
- pain on the upper right side of your stomach area (abdomen)
- bleeding or bruising more easily than normal
- feeling very tired
Your doctor will do blood tests to check your liver function during your treatment with GILOTRIF.
Tear (perforation) in your stomach or intestine. Tears in your stomach or intestine can happen with
GILOTRIF and can sometimes lead to death. Your risk of developing a tear in your stomach or intestine
may be increased if you:
- take certain medicines with GILOTRIF including: corticosteroids, nonsteroidal anti-inflammatory
drugs (NSAIDS), and certain other medicines.
- have a history of stomach or intestinal ulcers, or if you have had diverticular disease
(inflammation in parts of the large intestine)
Get medical help right away if you develop severe stomach-area (abdomen) pain during treatment with GILOTRIF.
Eye problems. Tell your doctor right away if you have symptoms of eye problems. Symptoms may include:
- eye pain, swelling, redness, or tearing
- blurred vision
- sensitivity to light
- other changes in your vision
Heart problems. Tell your doctor right away if you have any symptoms of a heart problem which may include:
- new or worsening shortness of breath while at rest or with activity
- swelling of your ankles, feet, or legs
- feeling that your heart is pounding or racing (palpitations)
- sudden weight gain
Your doctor may change your dose, temporarily stop or permanently stop treatment with GILOTRIF if you have certain side effects.
The most common side effects of GILOTRIF include diarrhea, rash, acne, mouth sores, nail inflammation,
dry skin, decreased appetite, nausea, vomiting, and itching.
GILOTRIF may cause decreased fertility in females and males. This may affect your ability to have a child.
Talk to your doctor if this is a concern for you.
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 pharmacist.
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 (NSCLC) that:
- 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 10.21.19