Safety & Side Effects

In a medical study of GILOTRIF, more than half of the people had their dose adjusted. GILOTRIF was still proven to be effective for them. For many people, side effects got better over time with proper management, such as dose adjustment.

DOSE ADJUSTMENT

Dose adjustments are often used to help with side effects

Some people may need to have their GILOTRIF dose adjusted to help with side effects. For instance, your healthcare provider may decide to pause your GILOTRIF treatment and then start treatment again at a lower dose. Don’t worry if your healthcare provider decides to adjust your GILOTRIF dose. You and your healthcare provider can work together to find the right dose for you. Your healthcare provider may change your dose, temporarily stop or permanently stop treatment with GILOTRIF if you have certain side effects.

Potential Serious Side Effects

In some people, GILOTRIF can cause serious side effects, some of which can lead to death, including diarrhea, lung or breathing problems, liver problems, and tear (perforation) in your stomach or intestine. Other serious side effects include skin reactions, eye problems, and heart problems.

Tell your healthcare provider right away if you have any of these symptoms:

Diarrhea (please see below for more information)

Skin reactions (please see below for more information)

Lung or breathing problems

Trouble breathing or shortness of breath
Cough
Fever

Liver problems

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

Increased risk of tear (perforation) in stomach or intestine if you:

Take certain medicines with GILOTRIF, including corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS)
Have a history of stomach or intestinal ulcers, or diverticular disease (inflammation in parts of large intestine)
Have severe stomach-area (abdomen) pain during treatment with GILOTRIF

Eye problems

Eye pain, swelling, redness, or tearing
Blurred vision
Sensitivity to light
Other changes in your vision

Heart problems

New or worsening shortness of breath while at rest or with activity
Cough
Tiredness
Swelling of your ankles, feet, or legs
Feeling that your heart is pounding or racing (palpitations)
Sudden weight gain

Check in with your healthcare provider often, especially during the first 2 weeks after starting treatment

Your healthcare provider will schedule regular checkups to see how you are doing. You will also have regular tests that tell your healthcare provider how your cancer is responding to GILOTRIF. Depending on how you are doing, your healthcare provider will update your treatment plan as needed.

Talk to your healthcare provider

If you feel uncomfortable or side effects become more serious or affect your daily activities; call your healthcare provider right away, even if it’s before your appointment
Track your condition by keeping a diary. This makes it easier to report back to your healthcare provider. You might want to use the "My Diary" included in your "My Support Kit" for this

Always take GILOTRIF exactly as prescribed, and do not change the dose or stop taking it unless told to do so by your healthcare provider.

Potential Common Side Effects Associated with GILOTRIF

The most common side effects of GILOTRIF include diarrhea, rash, acne, mouth sores, nail inflammation, dry skin, decreased appetite, nausea, vomiting, and itching. Please see below for more detailed information.

Diarrhea

Diarrhea is common with GILOTRIF and may sometimes be severe. If not treated properly, severe diarrhea can cause loss of too much body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with GILOTRIF, your healthcare provider should prescribe medicine to treat diarrhea. Take this medicine exactly as your healthcare provider tells you to.

Talk to your healthcare provider

When you first experience diarrhea and if diarrhea affects your daily activities
If you have pain or cramps in your stomach, fever, or dark, concentrated urine
If you have been treating your diarrhea for 2 days as your healthcare provider instructed but still have at least 4 bowel movements more than what is normal for you each day
Seek medical attention right away if your diarrhea becomes severe and your diarrhea medicine isn’t working

Your healthcare provider may recommend

Antidiarrheal medicine, such as loperamide
Pausing your GILOTRIF treatment and adjusting your dose
After several dose adjustments, or if your symptoms are severe, your healthcare provider may choose to stop GILOTRIF treatment permanently

Always take GILOTRIF exactly as prescribed, and do not change the dose or stop taking it unless told to do so by your healthcare provider.

TIPS ON MANAGING DIARRHEA:

Your healthcare provider may recommend changes to your diet.

Drink plenty of liquids

Drink plenty of water and other clear liquids (at least 3-4 quarts per day) to prevent dehydration.

Eat simply

Try to eat plain foods like rice, applesauce, bananas, and toast; and as you get better, include pasta, chicken, and turkey (without the skin), and eggs.

Keep clean

Diarrhea can cause painful skin damage. Make sure you regularly wash around the rectal area with warm water.

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 healthcare provider 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.

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.

Talk to your healthcare provider

When you first experience skin problems and/or if it affects your daily activities
If you have been treating them according to your healthcare provider’s instructions but they do not improve
If you develop severe skin problems, and get medical attention right away

Your healthcare provider may recommend

Pausing your GILOTRIF treatment and adjusting your dose
After several dose adjustments, or if your symptoms are severe, your healthcare provider may choose to stop GILOTRIF treatment permanently

Always take GILOTRIF exactly as prescribed, and do not change the dose or stop taking it unless told to do so by your healthcare provider.

THE PICTURES BELOW CAN HELP YOU DESCRIBE A RASH TO YOUR HEALTHCARE PROVIDER:

Wear sunscreen when outside (at least SPF 15), and moisturize regularly.

Mild

Looks like pus-filled pimples
Little itching or pain
Limited to 1 area of the body

Moderate

Looks like pus-filled pimples
Some itching or pain
May spread to more than 1 area of the body

Severe

Looks like pus-filled pimples
Increased itching and pain
Has spread to more than 1 area of the body
May become infected

Mouth sores

A possible side effect of GILOTRIF is stomatitis. This is an inflammation of the lining of the mouth. It may be accompanied by ulcers (sores or lesions). Be on the lookout for red, sore, or bleeding gums. Also watch for mouth ulcers on the tongue, lips, and on either the roof or the floor of your mouth.

Talk to your healthcare provider

If you feel uncomfortable or if sore mouth is affecting your daily activities
If you have been treating it according to your healthcare provider’s instructions but it does not improve

Your healthcare provider may recommend

Soothing mouth rinses, lozenges, and gels
Pausing your GILOTRIF treatment and adjusting your dose
After several dose adjustments, or if your symptoms are severe, your healthcare provider may choose to stop GILOTRIF treatment permanently

Always take GILOTRIF exactly as prescribed, and do not change the dose or stop taking it unless told to do so by your healthcare provider.

TIPS ON MANAGING MOUTH SORES:

Daily rinses and lozenges can be soothing.

Practice good oral care

Try brushing with a soft toothbrush; use a warm salt water rinse after meals and at bedtime; and avoid mouthwashes containing alcohol.

Eat for comfort

Eat foods that are cold or at room temperature that are soft, soothing, and moist, like soft fruit.

Soothe soreness

Use lip balm or petroleum jelly for dry lips, and ice or ice pops can numb the mouth as needed.

Nail inflammation

A possible side effect of GILOTRIF is paronychia. This is inflammation and infection of the skin that surrounds your nails.

Talk to your healthcare provider

If you feel uncomfortable or if inflammation is affecting your daily activities
If you have been treating it according to your healthcare provider’s instructions but it does not improve

Your healthcare provider may recommend

Creams that can be applied to the affected areas
Antibiotics to fight infections
Pausing your GILOTRIF treatment and adjusting your dose
After several dose adjustments, or if your symptoms are severe, your healthcare provider may choose to stop GILOTRIF treatment permanently

Always take GILOTRIF exactly as prescribed, and do not change the dose or stop taking it unless told to do so by your healthcare provider.

BE ON THE LOOKOUT FOR RED, SWOLLEN SKIN AROUND YOUR FINGERNAILS OR TOENAILS

Keep your fingernails clean to avoid irritation.

Mild

Nail inflammation begins as tender, red, and inflamed skin on the sides of the nail.

Moderate

As it becomes more severe, pus may collect around the nail and the infection may spread to the skin underneath.

Severe

Eventually, the cuticle and the skin around it may separate from the nail.

Decreased appetite

Eat 5 or 6 small meals each day instead of 3 large meals
Keep snacks nearby for when you feel like eating
Add extra protein and calories to your diet

GILOTRIF may cause decreased fertility in females and males. This may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider about side effects right away

Side effects such as diarrhea and skin rash can happen in the first 2 weeks of treatment. With proper care for your side effects, you may be able to keep taking GILOTRIF.
Tell your healthcare provider about any change in your health, even if it seems unrelated to lung cancer.

These are not all of the possible side effects of GILOTRIF. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SPF = sun protection factor; NSAIDs = nonsteroidal anti-inflammatory drugs; metastatic non-small cell lung cancer; EGFR = epidermal growth factor receptor.

GILOTRIF Resources and Financial Support
Eligible patients may receive support and have access to a variety of programs.

Review Resources

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.

or

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.

IMPORTANT SAFETY INFORMATION

Before you take GILOTRIF, tell your healthcare provider 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 healthcare provider 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 healthcare provider about birth control methods that may be right for you.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with GILOTRIF.
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 healthcare provider about the best way to feed your baby if you take GILOTRIF.

Tell your healthcare provider 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

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 healthcare provider should prescribe medicines to treat diarrhea. Take this medicine exactly as your healthcare provider tells you to. Tell your healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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 healthcare provider 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
- cough
- tiredness
- swelling of your ankles, feet, or legs
- feeling that your heart is pounding or racing (palpitations)
- sudden weight gain
Your healthcare provider 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 healthcare provider if this is a concern for you.

Tell your healthcare provider 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 healthcare provider 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 www.fda.gov/medwatch or call 1-800-FDA-1088.

CL-GF-100029 04.13.22