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

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 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

Please see Prescribing Information and Patient Information.