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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 medication that interferes with the growth and spread of cancer cells in the body.

Afatinib is used to treat non-small cell lung cancer that has spread to other parts of the body.

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

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

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

To make sure afatinib is safe for you, tell your doctor if you have:

  • kidney disease;
  • liver disease;
  • heart disease;
  • breathing problems or lung disease other than cancer; or
  • vision problems, a history of very dry eyes, or if you wear contact lenses.
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FDA pregnancy category D. Do not use afatinib if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use effective birth control to avoid pregnancy while you are using this medication and for at least 2 weeks after your treatment ends.

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It is not known whether afatinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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.

Afatinib is usually taken once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

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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.

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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.

While using afatinib, you may need frequent blood tests.

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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?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking afatinib?

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

What are the possible side effects of afatinib?

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

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

  • severe skin reaction that causes blistering and peeling;
  • 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;
  • heart problems --pounding heartbeats or fluttering in your chest, shortness of breath (even with mild exertion), swelling, rapid weight gain;
  • liver problems --nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • lung problems --fever, chest pain, dry cough, wheezing.

Common side effects may include:

  • mild diarrhea for 1 day or less, loss of appetite;
  • acne, dry skin, mild itching or skin rash; 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?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with afatinib, especially:

  • St. John's wort; or
  • an antibiotic --erythromycin, rifampin; antifungal medicine --itraconazole, ketoconazole; HIV or AIDS medicine --nelfinavir, ritonavir, saquinavir; heart or blood pressure medication --amiodarone, quinidine, verapamil; medicine to prevent organ transplant rejection --cyclosporine, tacrolimus; seizure medication --carbamazepine, phenobarbital, phenytoin.

This list is not complete. Other drugs may interact with afatinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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