Afatinib

Generic Name: afatinib (a-FA-ti-nib)
Brand Name: Gilotrif

Afatinib is used for:

Treating certain types of lung cancer. It may also be used for other conditions as determined by your doctor.

Afatinib is a kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use afatinib if:

  • you are allergic to any ingredient in afatinib

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using afatinib:

Some medical conditions may interact with afatinib. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems, liver or kidney problems, or lung problems other than lung cancer
  • if you have a history of inflammation of the eyes (keratitis) or other eye problems (eg, dry eyes, ulcers of the eye), or if you wear contact lenses

Some MEDICINES MAY INTERACT with afatinib. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for blood pressure, heart problems, HIV, immune system suppression, infections, seizures), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) because they may interact with afatinib. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with afatinib

This may not be a complete list of all interactions that may occur. Ask your health care provider if afatinib may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use afatinib:

Use afatinib as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with afatinib. Talk to your pharmacist if you have questions about this information.
  • Take afatinib by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
  • Take afatinib on a regular schedule about 24 hours apart, unless your doctor tells you otherwise.
  • Continue to take afatinib even if you feel well. Do not miss any doses.
  • If you miss a dose of afatinib, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use afatinib.

Important safety information:

  • Do NOT take more than the recommended dose, change your dose, or stop taking afatinib without checking with your doctor.
  • Tell your doctor or dentist that you take afatinib before you receive any medical or dental care, emergency care, or surgery.
  • Diarrhea is a common side effect of afatinib. If you get diarrhea, call your doctor right away for instructions on how to treat it. Do not treat diarrhea without first checking with your doctor. Severe or persistent diarrhea can cause you to become dehydrated and can sometimes be deadly. Discuss any questions or concerns you're your doctor.
  • Serious and sometimes fatal rashes have occurred with the use of afatinib. Contact your doctor at once if you develop a rash, including red, swollen, blistered, or peeling skin. Discuss any questions or concerns with your doctor.
  • Afatinib may cause you to become sunburned more easily. Avoid sunlamps and tanning booths. Limit your time in the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Severe and sometimes fatal lung problems have happened with afatinib. The chance may be greater in people of Asian descent. Call your doctor right away if you have new or worsening lung or breathing problems like trouble breathing, shortness of breath, cough, or fever. Discuss any questions or concerns with your doctor.
  • Severe and sometimes fatal liver problems have happened in patients taking afatinib. Tell your doctor right away if you develop symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness; yellowing of the skin or eyes).
  • A serious eye problem (keratitis) has happened in patients taking afatinib. Tell your doctor right away if you develop eye problems such as eye pain, redness, or swelling; tearing; light sensitivity; or vision changes (eg, blurred vision).
  • If you also take a medicine called vinorelbine, talk with your doctor. A higher rate of side effects and death have been seen when afatinib was taken with vinorelbine to treat a certain kind of breast cancer.
  • Women who may become pregnant must use an effective form of birth control while taking afatinib and for at least 2 weeks after the last dose. If you have questions about effective birth control, talk with your doctor.
  • Lab tests may be performed while you use afatinib. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Afatinib may cause harm to the fetus. Do not become pregnant while you are taking it and for at least 2 weeks after the last dose. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking afatinib while you are pregnant. It is not known if afatinib is found in breast milk. Do not breast-feed while taking afatinib.

Possible side effects of afatinib:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; chapped lips; diarrhea; dry skin; loss of appetite; mild itching; nosebleed; runny nose; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; change in the amount of urine produced; fast or irregular heartbeat; mouth irritation or sores in the mouth; nail problems; severe or persistent diarrhea; shortness of breath; sudden, unusual weight gain; swelling of the hands, arms, ankles, or legs; trouble urinating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of afatinib:

Store afatinib at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in the original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep afatinib out of the reach of children and away from pets.

General information:

  • If you have any questions about afatinib, please talk with your doctor, pharmacist, or other health care provider.
  • Afatinib is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take afatinib or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about afatinib. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to afatinib. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using afatinib.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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