Afatinib, Oral Tablet

Medically reviewed by University of Illinois-Chicago, Drug Information Group on May 20, 2016Written by University of Illinois-Chicago, Drug Information Group on December 5, 2017

Highlights for afatinib

  1. Afatinib oral tablet is available as a brand-name drug. It’s not available as a generic drug. Brand name: Gilotrif.
  2. Afatinib comes only as a tablet you take by mouth.
  3. Afatinib is used to treat non-small cell lung cancer (NSCLC) that is metastatic. Metastatic means the cancer has spread from your lungs to other parts of your body.

Important warnings

  • Diarrhea warning: It’s common for people taking this drug to have diarrhea. Sometimes this diarrhea can be severe. Severe diarrhea can cause dehydration (low fluid levels in the body) and kidney problems that can sometimes lead to death. During your treatment with afatinib, your doctor should also give you medication to treat diarrhea. Tell your doctor if you have diarrhea. Call your doctor right away if your diarrhea doesn’t go away or becomes severe.
  • Skin reactions warning: Afatinib can cause redness, rash, and acne. Call your doctor right away if you develop severe skin reactions such as peeling or blistering.
  • Lung or breathing problems warning: This drug can cause lung and breathing problems. Tell your doctor right away if you have new or worsening lung problems while taking this drug. These problems can include trouble breathing or shortness of breath, cough, or fever.
  • Liver problems warning: Afatinib can cause or worsen liver problems. Your doctor will likely do blood tests to check your liver function before and during your treatment with this drug. Call your doctor right away if you have any symptoms of liver problems. These can include yellowing of your skin or the whites of your eyes, dark or tea-colored urine, pain in the upper right side of your stomach area, bleeding or bruising more easily than normal, or increased tiredness.

What is afatinib?

Afatinib is a prescription drug. It comes as a tablet you take by mouth. It’s only available as the brand-name drug Gilotrif. It’s not available as a generic drug.

Why it's used

Afatinib is used to treat non-small cell lung cancer (NSCLC) that:

  • is metastatic (spread to other parts of your body besides your lungs), and
  • has abnormal epidermal growth factor (EGF) receptor genes. These abnormal genes promote the growth of cancer cells.

How it works

Afatinib belongs to a class of drugs called tyrosine kinase inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Afatinib targets certain proteins called EGF receptors within NSCLC cells. This action stops the cancer from growing and spreading.

Afatinib side effects

Afatinib oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects of afatinib can include:

  • decreased appetite
  • nausea
  • vomiting
  • diarrhea
  • mouth sores
  • acne
  • itchiness
  • rash
  • dry skin
  • nail infection

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Severe diarrhea
  • Skin reactions, such as blistering or peeling
  • Lung or breathing problems. Symptoms can include:
    • trouble breathing or shortness of breath
    • cough
    • fever
  • Liver problems. Symptoms can include:
    • yellowing of your skin or the whites of your eyes
    • dark or brown urine
    • pain in the upper right side of your abdomen (stomach area)
    • bleeding or bruising more easily than normal
    • tiredness
  • Keratitis (inflammation of the cornea). Symptoms can include:
    • eye pain, swelling, redness, or tearing
    • blurred vision
    • sensitivity to light
  • Heart problems. Symptoms can include:
    • new or worsening shortness of breath
    • cough
    • tiredness
    • swelling of your feet, ankles, or legs
    • pounding or fast heartbeat
    • sudden unexpected weight gain

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Afatinib may interact with other medications

Afatinib oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with afatinib are listed below.

Interactions that increase your risk of side effects

Taking afatinib with certain medications raises your risk of side effects from afatinib. This is because the amount of afatinib in your body may be increased when you also take these drugs. Examples of these drugs include:

  • P-glycoprotein inhibitors, such as amiodarone, cyclosporine A, erythromycin, itraconazole, ketoconazole, nelfinavir, quinidine, ritonavir, saquinavir, tacrolimus, and verapamil: Your doctor may decrease your dosage of afatinib if you take it with any of these drugs.

Interactions that can make afatinib less effective

When afatinib is used with certain drugs, it may not work as well to treat your condition. This is because the amount of afatinib in your body may be decreased. Examples of these drugs include:

  • P-glycoprotein inducers, such as carbamazepine, rifampicin, phenytoin, phenobarbital, and St. John’s wort: Your doctor may increase your dosage of afatinib if you take it with any of these drugs.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Afatinib warnings

This drug comes with several warnings.

Allergy warning

Afatinib can cause a severe allergic reaction. Symptoms can include:

  • trouble breathing
  • swelling of your throat or tongue

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Food interaction warning

Eating grapefruit or drinking grapefruit while taking afatinib can cause this drug to build up in your body. This raises your risk of side effects.

Warnings for people with certain health conditions

For people with kidney problems: You may not be able to clear this drug from your body well. This may increase the levels of afatinib in your body and cause more side effects. If you have moderate to severe kidney problems, your doctor should monitor you closely while you take this drug. Your doctor will change your dosage if needed.

For people with liver problems: Afatinib may cause liver damage. If you have severe liver problems, your doctor should monitor you closely while you take this drug. Your doctor will change your dosage if needed.

For people with lung or breathing problems: Tell your doctor if you have lung or breathing problems other than lung cancer. Afatinib can make your condition worse.

For people with eye problems: This drug has been known to cause a condition called keratitis (inflammation of the cornea). Keratitis can lead to eye pain, tearing, light sensitivity, and blurred vision. If you have certain eye problems, taking this drug could make them worse. Before you take this drug, let your doctor know if you have a history of severely dry eyes or any other eye problems.

For people with heart problems: Let your doctor know if you have any heart problems. Afatinib can damage your heart and make your condition worse.

Warnings for other groups

For pregnant women: Afatinib is a category D pregnancy drug. That means two things:

  1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
  2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

Tell your doctor right away if you are pregnant or plan to become pregnant. Afatinib can harm your pregnancy. You should not become pregnant while taking this drug. If you are a woman of childbearing age, use effective birth control during your treatment and for at least 2 weeks after your last dose. Talk with your doctor about forms of birth control that may be right for you.

If you become pregnant while taking this drug, call your doctor right away.

For women who are breastfeeding: It isn’t known if afatinib passes into breast milk or causes side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For children: This medication has not been studied in children. It should not be used in children younger than 18 years.

How to take afatinib

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

Dosage for metastatic non-small cell lung cancer

Brand: Gilotrif

  • Form: oral tablet
  • Strengths: 20 mg, 30 mg, 40 mg

Adult dosage (ages 18 years and older)

Typical dosage: 40 mg taken once per day.

Child dosage (ages 0–17 years)

This medication has not been studied in children. It should not be used in children younger than 18 years of age.

Special dosage considerations

For people with severe kidney problems: The typical recommended dosage is 30 mg taken once per day.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Take as directed

Afatinib oral tablet can be used for short-term or long-term treatment. Your length of treatment depends on what side effects you have and how well the medication is working to treat your cancer.

This drug comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your cancer won’t be treated and could spread to other parts of your body. Over time, this could be fatal (cause death).

If you miss doses or don’t take the drug on schedule: Your cancer might not be treated well enough and may get worse.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

  • headache
  • dizziness
  • nausea
  • vomiting
  • stomach pain
  • lack of energy

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. If it is within 12 hours of your next dose, skip the dose and take your next dose at your regular time. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: You may not feel any improvement even when the drug is working. Your doctor will do tests to make sure that the drug is working for you.

Important considerations for taking afatinib

Keep these considerations in mind if your doctor prescribes afatinib for you.

General

  • Take afatinib on an empty stomach. You should take it at least 1 hour before a meal, or 2 hours after a meal.
  • Do not cut or crush the tablet.

Storage

  • Store afatinib at room temperature between 68°F and 77°F (20°C and 25°C).
  • Keep this drug in the original container and keep the container tightly closed.
  • Keep this medication away from light.
  • Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t harm your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor should monitor certain health issues while you take this drug. These issues include your:

  • Liver function: Blood tests can help your doctor check how well your liver is working. If your liver isn’t working well, your doctor may decrease your dosage or stop your treatment with this drug.
  • Kidney function: Blood tests can help your doctor check how well your kidneys are working. If your kidneys aren’t working well, your doctor may decrease your dosage or stop your treatment with this drug.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Sun sensitivity

Afatinib can make your skin more sensitive to the sun. This increases your risk of rash, acne, and severe sunburn. Avoid the sun if you can. If you can’t, be sure to wear protective clothing and use sunscreen.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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