Afatinib treats a certain type of lung cancer. It must be taken 1 hour before or 2 hours after eating food. Limit your time in the sun and wear sunscreen. Diarrhea is common side effect.

Afatinib Overview

Reviewed: October 10, 2013

Afatinib is a prescription medication used to treat patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express a specific type of gene mutation. This mutation is of the epidermal growth factor receptor (EGFR). Afatinib is also used to treat advanced squamous cell lung cancer

Afatinib belongs to a group of drugs called tyrosine kinase inhibitors which block proteins that promote the development of cancerous cells.

This medication comes in tablet form and is taken on an empty stomach.

Common side effects include diarrhea, rash, and mouth sores.

Afatinib Genetic Information

Non-small cell lung cancer (NSCLC) results from uncontrolled growth of cells in the lungs. Epidermal growth factor receptor (EGFR) is a protein found on the surface of cancer cells that controls the growth of cancer cells.

Some patients have mutations (changes) in this protein that lead cells to grow and divide more rapidly. Having these mutations increases the chance that afatinib will help slow or stop the growth of lung cancer cells. If testing for this mutation in EGFR is not done, afatinib is not likely to be an effective treatment.

Afatinib is FDA approved for the treatment of NSCLC carrying this EGFR mutation. Afatinib is targeted to this specific EGFR protein on cancer cells.


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Afatinib Cautionary Labels


Uses of Afatinib

Afatinib is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC), 

  • that have certain types of abnormal epidermal growth factor receptor (EGFR) genes, and 
  • who have not had previous treatment for cancer that has spread to other parts of the body 

Afatinib is also used to treat advanced squamous cell lung cancer that has progressed after treatment with platinum-based chemotherapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Afatinib Brand Names

Afatinib may be found in some form under the following brand names:

Afatinib Drug Class

Afatinib is part of the drug class:

Side Effects of Afatinib

The most common side effects include: 

  • diarrhea
  • rash
  • mouth sores
  • nail infection
  • dry skin
  • acne
  • decreased appetite
  • itching

Tell your doctor if you have any side effect that bothers you or that does not go away.

Serious side effects may occur. See "Drug Precautions" section.

These are not all of the possible side effects of afatinib. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Afatinib Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Afatinib may affect the way other medicines work, and other medicines may affect the way afatinib works.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.


Afatinib Precautions

Limit your time in the sun. Afatinib can make your skin sensitive to the sun. 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 while you are taking afatinib if you have to be in sunlight.

Afatinib may cause serious side effects, including: 
  • diarrhea. Diarrhea is common with afatinib 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 afatinib, 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. Afatinib 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. 
  • lung or breathing problems. 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 
    • fever 
  • liver problemsYour doctor will do blood tests to check your liver function during your treatment with afatinibTell 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 
  • eye problems. Tell your doctor right away if you have symptoms of eye problems which 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 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


Afatinib Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of afatinib, there are no specific foods that you must exclude from your diet when receiving this medication.

Inform MD

Before you take afatinib, tell your doctor if you: 

  • have kidney or liver problems
  • have lung or breathing problems other than lung cancer 
  • 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 breastfeeding

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Afatinib and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. Afatinib can harm your unborn baby. You should not become pregnant while taking afatinib.

  • Women who are able to become pregnant should use effective birth control during treatment with afatinib and for at least 2 weeks after your last dose of afatinib. Talk to your doctor about birth control methods that may be right for you. 
  • Tell your doctor right away if you become pregnant while taking afatinib.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. It has been shown that use of afatinib in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.


Afatinib and Lactation

It is not known if afatinib crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. You should not do both.


Afatinib Usage

Take afatinib exactly as your doctor tells you to take it. 
  • Your doctor will tell you how many afatinib tablets to take and when to take them. Do not change your dose or stop afatinib unless your doctor tells you to. 
  • Take afatinib on an empty stomach at least 1 hour before a meal or 2 hours after a meal. 
  • If you miss a dose of afatinib, take it as soon as you remember. If it is within 12 hours of your next dose, skip the dose and just take your next dose at your regular time. 
  • Do not take 2 doses of afatinib at the same time. 


Afatinib Dosage

Take afatinib exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of afatinib to treat late stage (metastatic) non-small cell lung cancer (NSCLC) is 40 mg orally once daily.


Afatinib Overdose

If you take too much afatinib, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If afatinib is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Other Requirements

  • Store afatinib at room temperature between 68°F to 77°F (20°C to 25°C). 
  • Keep afatinib in the original container and keep the container tightly closed. 
  • Keep afatinib away from moisture and light. 
  • Safely throw away (discard) any afatinib that is out of date or no longer needed.