Gilotrif

Generic Name: afatinib (a FAT i nib)
Brand Names: Gilotrif

What is Gilotrif?

Gilotrif (afatinib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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

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

Important information

Minimize sun exposure with protective clothing and use of sunscreen while taking Gilotrif tablets.

Diarrhea occurs in nearly all patients who receive Gilotrif. Severe diarrhea may result in dehydration and renal impairment. Call your doctor if you are sick with severe diarrhea, or diarrhea lasting longer than 2 days.

Slideshow: Flashback: FDA Drug Approvals 2013

Call your doctor at once if you experience eye pain, swelling, redness, blurred vision, or other vision change.

Call your doctor at once if you experience any of the following: new onset or worsening shortness of breath or exercise intolerance, cough, fatigue, swelling of the ankles/legs, palpitations, or sudden weight gain.

Before taking this medicine

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

To make sure Gilotrif 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.

FDA pregnancy category D. Do not use Gilotrif 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.

See also: Pregnancy and breastfeeding warnings (in more detail)

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 Gilotrif?

Take Gilotrif tablets exactly as prescribed by your doctor. Before you start treatment, your doctor may perform tests to make sure Gilotrif is the best treatment for your type of lung cancer.

Gilotrif 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.

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

Gilotrif 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 Gilotrif. 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 this medicine for a short time.

While using Gilotrif, you may need frequent blood 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 Gilotrif 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?

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

What should I avoid?

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

Gilotrif side effects

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

Stop using Gilotrif 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 Gilotrif 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.

See also: Side effects (in more detail)

What other drugs will affect Gilotrif?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Gilotrif, 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 Gilotrif, 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 Gilotrif.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Gilotrif only for the indication prescribed.
  • Disclaimer: 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.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2013-07-25, 4:22:32 PM.

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