Afatinib (Gilotrif) is a cancer drug used to treat non-small cell lung cancer (NSCLC) that is EGFR (epidermal growth factor receptor)-positive, which means that it is caused by an abnormal EGFR gene or genes.

The EGFR protein is found on the surface of cells and helps them to grow, but when the gene for EGFR is defective or abnormal cells can grow out of control causing cancer.

Afatinib belongs to a class of drugs called kinase inhibitors. It is an EGFR tyrosine kinase inhibitor that works by irreversibly blocking EGFR.

Afatinib helps to stop or slow the spread of cancer and may help people with EGFR-positive NSCLC live longer. It was approved by the US Food and Drug Administration in 2013.

What is Afatinib used for?

Afatinib is a prescription medicine that is used to treat people with:

• NSCLC that has:
  • has certain (non-resistant) abnormal EGFR gene(s). Your healthcare provider will perform a test to make sure that this medication 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 this medication is safe and effective in treating people with lung cancer that has resistant abnormal EGFR genes.
• 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 this medication is safe and effective in children.

• Take afatinib exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how many tablets to take and when to take them. Do not change your dose or stop taking this medication unless your healthcare provider tells you to.
• Take afatinib on an empty stomach at least 1 hour before a meal or 2 hours after a meal.

• The recommended dose of afatinib is 40 mg orally once daily.
• In patients with severe renal impairment the recommended dose of afatinib is 30 mg orally once daily
• Take this medication at least 1 hour before or 2 hours after a meal
• See full prescribing information for further dosing information

Before you take afatinib, tell your healthcare provider about all of your medical conditions, including 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. See “What are the side effects of afatinib?” below
• have a history of severe dry eye or any other eye problems. Tell your healthcare provider if you wear contact lenses.
• have heart problems

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 this medication at the same time.

If you take too much afatinib, call your healthcare provider or go to the nearest hospital emergency room right away.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Limit your time in the sun. Afatinib 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 this medication.

Serious side effects of afatinib include:

• Diarrhea. Diarrhea is common with this medication and may sometimes be severe. Severe diarrhea can cause loss of too much body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with afatinib, 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. 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 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. Afatinib 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. Afatinib 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 this medication.
• Tear (perforation) in your stomach or intestine. Tears in your stomach or intestine can happen with this medication 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 afatinib 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 afatinib.
• Eye problems. Tell your healthcare provider 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 healthcare provider 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

Your healthcare provider may change your dose, temporarily stop or permanently stop treatment with this medication if you have certain side effects.

The most common side effects of afatinib include:

• diarrhea
• rash
• acne
• mouth sores
• nail inflammation
• dry skin
• decreased appetite
• nausea
• vomiting
• itching

Afatinib 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 this medication. 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-FDA1088.

Tell your healthcare provider 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. Taking certain medicines with this medication may increase your risk of developing a tear (perforation) in your stomach or intestine. See “What are the side effects of afatinib?” above.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to afatinib.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.