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Overview: Gilotrif is used to treat certain types of non-small-cell lung cancer. Common side effects include diarrhea, rash, and mouth sores. Call your health care provider right away if you get a rash, fever, changes in your vision, new or worsening shortness of breath, or severe diarrhea. Get emergency help if you get blisters inside your mouth or blistering or peeling of your skin.

Uses

What is Gilotrif used for?

Gilotrif (afatinib) is commonly used to treat certain types of non-small-cell lung cancer (NSCLC).

Gilotrif may also be used for other conditions as determined by your health care provider.

How does Gilotrif work (mechanism of action)?

Gilotrif is a type of medicine known as a tyrosine kinase inhibitor. It works by targeting specific proteins on cancer cells. By blocking the action of these proteins, Gilotrif can cause cancer cells to die and prevent them from growing or spreading.

How is Gilotrif supplied (dosage forms)?

Brands and other names

  • Gilotrif

Dosage forms and strengths

  • 20 mg, 30 mg, 40 mg oral tablets

How should I store Gilotrif?

Gilotrif should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep Gilotrif in the original container and away from light.

Side Effects

What are the most common side effects of Gilotrif?

The most common side effects of Gilotrif are listed below. Tell your health care provider if you have any of these side effects that bother you. 

  • Diarrhea (see below)
  • Rash
  • Acne
  • Mouth sores
  • Skin redness, swelling, or pain around your fingernails or toenails
  • Dry skin
  • Loss of appetite
  • Nausea and vomiting
  • Itching

There may be other side effects of Gilotrif that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Gilotrif?

While less common, the most serious side effects of Gilotrif are described below, along with what to do if they happen.

Severe Allergic Reactions. Gilotrif may cause allergic reactions, which can be serious. Stop taking Gilotrif and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Diarrhea. Diarrhea is common with Gilotrif but can be severe and cause kidney problems. Call your health care provider right away if you get diarrhea or if you have more than two bowel movements in one day. If you are given medicine to prevent or treat diarrhea, take it exactly as your health care provider tells you. Call your health care provider right away if you have any of the following.

  • Severe diarrhea
  • Diarrhea that does not go away
  • Diarrhea with weakness, dizziness, or fever

Severe Skin Reactions. Gilotrif can cause severe skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), as well as blistering and peeling of your skin that can lead to death if not treated. If you develop a rash, call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms, including fever, chills, and muscle aches

Lung Inflammation. Gilotrif can cause inflammation in your lungs, also called interstitial lung disease orpneumonitis. This can be serious or even life-threatening. Get emergency help if you have new or worsening trouble breathing. You may also have a cough, fever, or chest pain. 

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Gilotrif. Keep all appointments to have your blood checked. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Stomach Bleeding. Gilotrif can increase your risk of tears (perforation) in your gut. Stop taking Gilotrif and get emergency help if you have any of the following symptoms.

  • Vomit blood
  • Black or tarry poop
  • Stomach pain that does not go away
  • Upset stomach
  • Feel faint

Severe Eye Problems. Gilotrif may cause eye problems, such as inflammation of the cornea (keratitis). Contact your health care provider right away if you have any of the following symptoms.

  • Eye redness, itchiness, or pain
  • Swollen or itchy eyelids
  • Feeling like you have something in your eye
  • Eye dryness, watering, or discharge
  • Vision changes, such as blurry vision or sensitivity to light

Heart Problems. Gilotrif may cause serious heart problems. Contact your health care provider right away if you have any of the following symptoms.

  • New or worsening shortness of breath
  • Trouble breathing while exercising
  • Cough
  • Tiredness
  • Swelling in your legs or ankles
  • Feeling your heart skip beats
  • Sudden weight gain

Warnings & Precautions

Who should not use Gilotrif?

Allergies to Ingredients. People who are allergic to any of the following should not take Gilotrif.

  • Afatinib
  • Gilotrif
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Gilotrif.

What should I know about Gilotrif before using it?

Do not take Gilotrif unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Gilotrif with other people, even if they have the same condition as you. It may harm them.

Keep Gilotrif out of the reach of children.

Your health care provider will have you do regular blood tests before taking and while taking Gilotrif. Make sure to attend all appointments, so they can make sure that Gilotrif is safe for you.

Gilotrif can make your skin more sensitive to light from the sun, sunlamps, and tanning beds. This is called photosensitivity. Exposure to this light can cause severe sunburns, blisters, and swelling. If you need to be in sunlight, wear sunscreen, a hat, and clothing that covers your skin.

Gilotrif may make it difficult for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

What should I tell my health care provider before using Gilotrif?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Gilotrif is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Eye problems, including dry eye or if you wear contact lenses
  • Heart problems, including cardiomyopathy or heart failure
  • Breathing problems
  • Stomach or digestion problems, such as a previous ulcer, tear in your stomach or intestine, a cancer in your intestines, or any type of inflammation of your intestines
  • Liver problems
  • Kidney problems

Other Medicines and Supplements. Gilotrif may interact with other medicines and supplements. Before taking Gilotrif, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Gilotrif may cause harm to a fetus. Your health care provider may give you a test to make sure you are not pregnant before you start taking Gilotrif. If you are able to get pregnant, you should use birth control while taking Gilotrif and for at least two weeks after your last dose. Tell your health care provider right away if you are pregnant, think you are pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Gilotrif passes into breast milk. You should not breastfeed while taking Gilotrif and for two weeks after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Gilotrif?

For more information about Gilotrif, you can visit the drugmaker’s website at www.gilotrif.com or call them at 800-542-6257.

Interactions

Does Gilotrif interact with foods or drinks?

Gilotrif should be taken on an empty stomach and at least one hour before a meal or two hours after a meal.

It is unknown if drinking alcohol will affect Gilotrif, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Gilotrif interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

 In particular, make sure that you discuss if you are using any of the following before taking Gilotrif.

  • Itraconazole (Sporanox, Tolsura)or ketoconazole, which are medicines used for fungal infections
  • Nelfinavir (Viracept), ritonavir (Norvir), or saquinavir, which are medicines commonly used to treat HIV
  • Cyclosporine (Gengraf, Neoral, Sandimmune, and others) or tacrolimus, which are medicines that suppress your immune system
  • Erythromycin (Ery-Tab and others), which is a medicine used for bacterial infections
  • Verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or other conditions
  • Quinidine, which is a medicine used to treat malaria or control your heart rate or rhythm
  • Amiodarone (Pacerone and others), which is a medicine used for an irregular heart rhythm
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • Phenobarbital, which is a medicine that may be used to treat seizures
  • St. John’s wort, which is a supplement that may be used for depression
  • A corticosteroid, such as dexamethasone, methylprednisolone, or prednisone, which is a medicine for certain inflammatory conditions
  • A nonsteroidal anti-inflammatory drug (NSAID), such as ibuprofen, naproxen, and others, which is in many prescription and over-the-counter (OTC) products for pain, swelling, and fever

Some other medicines may alter the blood levels of Gilotrif. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Gilotrif. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Gilotrif?

If you or someone else has used too much Gilotrif, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Gilotrif?

If you miss a dose, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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