1 What is Gilotrif?

Brand: Gilotrif

Generic: Afatinib

Gilotrif is used to treat metastatic (cancer that has spread) non-small cell lung cancer (NSCLC) that has specific types of abnormal epidermal growth factor receptor (EGFR) genes in patients who have not recieved treatments for cancer that has spread to other parts of the body.

This medication is only available with your doctor’s prescription.

This medication is available in the following forms:

  • Tablet
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2 What to Know Before Using

Before using Gilotrif, you must know all about the risks and complications associated with it.

For this medication, there are many things that need to be considered:

  • Allergies: Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
  • Pediatric: No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.
  • Geriatric: Up-to-date studies have not shown specific problems that would limit the use of this medication in the elderly.
  • Pregnancy: This medication is listed as Pregnancy Category D. This means that studies in pregnant women have demonstrated a risk to the unborn child. However, the benefits of this medication in a life-threatening situation or serious disease may outweigh the potential risk.
  • Breastfeeding: There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
  • Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below.

The following interactions were selected on the basis of potential significance and are not all-inclusive. Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases.

Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

    • Abiraterone
    • Amiodarone
    • Azithromycin
    • Captopril
    • Carbamazepine
    • Carvedilol
    • Clarithromycin
    • Cobicistat
    • Conivaptan
    • Cyclosporine
    • Diltiazem
    • Dronedarone
    • Eliglustat
    • Erythromycin
    • Felodipine
    • Fosphenytoin
    • Itraconazole
    • Ketoconazole
    • Lomitapide
    • Lopinavir
    • Nelfinavir
    • Nilotinib
    • Phenytoin
    • Primidone
    • Quercetin
    • Quinidine
    • RanolazineRifampin
    • Ritonavir
    • Saquinavir
    • Simeprevir
    • St. John’s Wort
    • Tacrolimus
    • Telaprevir
    • Ticagrelor
    • Ticagrelor
    • Tipranavir
    • Tocophersolan
    • Verapamil
  • Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain medications may cause other interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.
  • Other Medical Problems: The pre-existence of other medical problems may affect the use of this medication.

Inform you doctor of any other medical problems you may have, especially:

3 Proper Usage

To use Gilotrif correctly, you must follow all instructions given by your doctor.

Medications used to treat cancer are very strong and can cause many side effects. Before taking this medication, be sure you understand all the risks and benefits.

Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.

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


Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

For oral dosage forms (tablets):

  • Adults - 40mg once a day.
  • Children - Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

Do not take this medication if it has been more than 12 hours since your last dose. Do not take two doses at once.


Store this medication in a closed container at room temperature. Keep it away form heat, moisture and direct light. Do not freeze.

Keep our of the reach of children

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

4 Precautions to Take

Before using Gilotrif, there are some precautions you must take.

It is very important that your doctor checks in with the you often while you are receiving this medication to make sure that it is working properly. Blood tests may be needed to check for unwanted effects.

Using this medication while pregnant can harm your unborn child. Use an effective form of birth control to keep from becoming pregnant while taking this medication, and for 2 weeks after the last dose of this medication. If you think you have become pregnant while on this medication, inform your doctor immediately.

  • Inform your doctor immediately if you experience diarrhea while taking this medication. You may need other medications to help manage or prevent diarrhea.
  • Skin reactions (Ex. acne, rash, redness) may occur while you use this medication. Inform your doctor immediately if you develop severe skin reactions such as blistering, skin peeling or severe rash. Avoid overexposing your skin to sunlight. Always use sunscreen or sun-blocking lotions and wear protective clothing and hats while taking this medication.
  • Inform your doctor immediately if you begin having breathing problems, chest pain, shortness of breath, cough, fever or chills. These could be signs of a serious lung problem.
  • Inform your doctor immediately if you have pain or tenderness in the upper stomach, pale stool, dark urine, loss of appetite, nausea, unusual fatigue or weakness or yellow eyes or skin (jaundice). These could be signs of a serious liver problem.
  • Inform you doctor immediately if you have vision changes such as blurred vision, difficulty reading or eye pain, irritation or swelling during or after treatment. Your doctor may want you to have your eyes checked by an opthamologist. Inform you doctor if you wear contact lenses.
  • Inform your doctor immediately if you have difficulty breathing, cough, fast or uneven heartbeat (palpitations, tachycardia), rapid weight gain, swelling of the ankles or legs, or unusual fatigue or weakness.

Do not take other prescription or over-the-counter medications without asking your doctor.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Gilotrif. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

  • Bloody or cloudy urine
  • Burning, dry, or itching eyes
  • Diarrhea
  • Difficult, burning, or painful urination
  • Discharge or excessive tearing
  • Fever
  • Frequent urge to urinate (polyuria)
  • Redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • Redness, swelling, or pain of the skin
  • Scaling of the skin on the hands and feet
  • Tingling of the hands and feet
  • Ulceration of the skin

Less common:

Seek emergency help immediately if any of the following symptoms of overdose occur:

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More Common:

  • Acne
  • Blemishes on the skin
  • Canker sores
  • Chapped, red, or swollen lips
  • Decreased appetite
  • Dry skin
  • Itching skin
  • Loosening of the fingernails
  • Nosebleeds
  • Rash
  • Redness or soreness around the fingernails
  • Runny nose
  • Scaling, redness, burning, pain, or other signs of inflammation of the lips
  • Sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • Unintentional weight loss

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

Ask your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

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