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afatinib

Pronunciation: a FAT i nib

Brand: Gilotrif

What is the most important information I should know about afatinib?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is afatinib?

Afatinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Afatinib is used to treat a certain type of non-small cell lung cancer that has spread to other parts of the body. Afatinib is used for this condition only if your tumor has a specific genetic marker for which your doctor will test.

Afatinib is also used to treat squamous non-small cell lung cancer that has spread to other parts of the body after other cancer medicine has been tried without successful treatment.

Afatinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking afatinib?

You should not use afatinib if you are allergic to it.

Tell your doctor if you have ever had:

  • kidney disease;
  • liver disease;
  • heart disease;
  • breathing problems or lung disease other than cancer; or
  • vision problems, very dry eyes, or if you wear contact lenses.

Afatinib may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks after your last dose. Tell your doctor if you become pregnant.

Do not not breast-feed while using this medicine and for 2 weeks after your last dose.

How should I take afatinib?

Before you start treatment, your doctor may perform tests to make sure afatinib is the best treatment for your type of lung cancer.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take afatinib on an empty stomach, at least 1 hour before or 2 hours after a meal.

Afatinib can cause severe diarrhea, which can be life-threatening if it leads to dehydration. You may be given medications to prevent or quickly treat diarrhea.

Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are taking afatinib. Take the anti-diarrhea medicine as directed on the label, or as prescribed by your doctor.

Call your doctor if you are sick with severe diarrhea, or diarrhea lasting longer than 2 days. You may need to stop taking afatinib for a short time.

You will need frequent medical tests.

Store the tablets in their original container at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Throw away any afatinib tablets not used before the expiration date on the medicine label.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking afatinib?

Afatinib could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of afatinib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using afatinib and call your doctor at once if you have:

  • new or worsening cough, fever, or trouble breathing;
  • severe or ongoing diarrhea (lasting 2 days or longer);
  • severe skin reaction that causes blistering and peeling;
  • pain, redness, numbness, and peeling skin on your hands or feet;
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • eye problems --eye pain or redness, blurred vision, watery eyes, feeling like something is in your eye, increased sensitivity to light;
  • liver problems --stomach pain (upper right side), easy bruising or bleeding, feeling tired, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • heart problems --pounding heartbeats or fluttering in your chest, shortness of breath (even with mild exertion), swelling in your legs or ankles, rapid weight gain.

Common side effects may include:

  • mild diarrhea for 1 day or less;
  • nausea, vomiting, loss of appetite;
  • mouth sores;
  • acne, itching, dry skin; or
  • redness, pain, swelling, or other signs of infection around your fingernails or toenails.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect afatinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect afatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about afatinib.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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