Learn about support and programs that may help you pay for GILOTRIF.

Get the answers you need for the road ahead

What is GILOTRIF?

GILOTRIF is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC),

• that has certain types of abnormal epidermal growth factor receptor (EGFR) genes. Your doctor will perform a test to check for certain types of abnormal EGFR genes, and make sure that GILOTRIF is right for you. GILOTRIF may be used when you have not had previous treatment for cancer that has spread to other parts of the body. It is not known if GILOTRIF is safe and effective in treating lung cancer with other abnormal EGFR genes.

or

• that is squamous type and has spread to other parts of the body after you have tried chemotherapy that contains platinum.

It is not known if GILOTRIF is safe and effective in children.

Is GILOTRIF covered by insurance?

Yes, many insurance plans cover GILOTRIF. But no matter what your health insurance status, there are a number of different ways we may be able to help:

  • Reimbursement Specialists at Solutions Plus who work with you to resolve issues you may have with benefit verification, prior authorization, or denials and appeal of claims
  • A Co-pay Assistance Program that allows eligible, commercially insured patients to pay no more than a $25 co-pay per month for their medicine
  • Connecting you with charitable foundations that can help you offset the cost of your co-pays, co-insurance, or other treatment-related expenses if you are insured by a Medicare plan
  • The BI Cares Foundation can help uninsured or underinsured Medicare patients who may be eligible for free treatment with GILOTRIF that have been previously denied financial assistance from other foundations

If you get your GILOTRIF through Accredo® Pharmacy and meet other program eligibility requirements:

  • Accredo will refund your money and your insurer's payment if you discontinue treatment before your first prescription refill, you have participating commercial insurance, and you are enrolled in the Nurse Support Program
  • Accredo will also exchange your old dose for a new one—up to 2 times—if your doctor prescribes a dose change and sends in the enrollment and prescription form through Solutions Plus, and you have 9 or more tablets to exchange

Accredo is a registered trademark.

 

How do I know if GILOTRIF is right for me?

Your doctor may consider GILOTRIF if you:

  • Have non-small cell lung cancer that has certain types of epidermal growth factor receptor (EGFR) genes, which are identified using a biomarker test that is FDA approved
  • Have not had previous treatment for cancer that has spread to other parts of the body

Ask your doctor if GILOTRIF is right for you.

How do I take GILOTRIF?

Take GILOTRIF exactly as your doctor tells you to take it.

Your doctor will tell you how many GILOTRIF tablets to take and when to take them. Do not change your dose or stop taking GILOTRIF unless your doctor tells you to.

GILOTRIF is a tablet taken by mouth. Take GILOTRIF on an empty stomach at least 1 hour before a meal or 2 hours after a meal. GILOTRIF may not be absorbed by your body properly if taken too close to eating.

If you miss a dose of GILOTRIF, take it as soon as you remember. If it is within 12 hours of your next dose, skip the dose and just take your next dose at your regular time.

Do not take 2 doses of GILOTRIF at the same time.

If you take too much GILOTRIF, call your doctor or go to the nearest hospital emergency room right away.

Learn more about the right way to take GILOTRIF.

How does GILOTRIF work?

If your doctor has prescribed GILOTRIF, it is because you have been tested and found to have certain types of abnormal epidermal growth factor receptor (EGFR) gene mutations. Abnormal EGFR gene mutations are also referred to as EGFR mutations or EGFR M+. GILOTRIF works by attaching to these EGFR M+ molecules, and helping to block these cancer-causing signals.

What Important Safety Information should I know about GILOTRIF?

Important Safety Information about GILOTRIF

Before you take GILOTRIF, tell your doctor if you:

  • have kidney or liver problems
  • have lung or breathing problems other than lung cancer
  • have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
  • have heart problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. GILOTRIF can harm your unborn baby. You should not become pregnant while taking GILOTRIF.

    • Women who are able to become pregnant should use effective birth control during treatment with GILOTRIF and for at least 2 weeks after your last dose of GILOTRIF. Talk to your doctor about birth control methods that may be right for you.
    • Tell your doctor right away if you become pregnant or think you are pregnant while taking GILOTRIF.
  • are breastfeeding or plan to breastfeed. It is not known if GILOTRIF passes into your breast milk. Do not breastfeed while taking GILOTRIF and for 2 weeks after your last dose of GILOTRIF. Talk to your doctor about the best way to feed your baby if you take GILOTRIF.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GILOTRIF may affect the way other medicines work, and other medicines may affect the way GILOTRIF works.

What to avoid while taking GILOTRIF

Limit your time in the sun. GILOTRIF can make your skin sensitive to the sun. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin while you are taking GILOTRIF if you have to be in sunlight.

GILOTRIF may cause serious side effects, including:

  • Diarrhea. Diarrhea is common with GILOTRIF and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with GILOTRIF, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.
  • Skin reactions. GILOTRIF can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth.
  • Lung or breathing problems. GILOTRIF may cause inflammation of the lung that may lead to death.  Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever.
  • Liver problems. GILOTRIF can cause liver problems that can sometimes lead to death.  Tell your doctor right away if you have any symptoms of a liver problem which may include:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • dark or brown (tea colored) urine
    • pain on the upper right side of your stomach area (abdomen)
    • bleeding or bruising more easily than normal
    • feeling very tired

Your doctor will do blood tests to check your liver function during your treatment with GILOTRIF.

  • Eye problems. Tell your doctor right away if you have symptoms of eye problems. Symptoms may include:
    • eye pain, swelling, redness, or tearing
    • blurred vision
    • sensitivity to light
    • other changes in your vision
  • Heart problems. Tell your doctor right away if you have any symptoms of a heart problem which may include:
    • new or worsening shortness of breath while at rest or with activity
    • cough
    • tiredness
    • swelling of your ankles, feet, or legs
    • feeling that your heart is pounding or racing (palpitations)
    • sudden weight gain

The most common side effects of GILOTRIF include diarrhea, rash, mouth sores, nail inflammation, dry skin, acne, decreased appetite, nausea, vomiting, itching.

GILOTRIF may cause decreased fertility in females and males. Talk to your doctor if you have concerns about your fertility.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of GILOTRIF. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information, including Patient Information .

What are the most common side effects I may experience with GILOTRIF?

Talk to your doctor about the most common side effects of GILOTRIF, which include diarrhea, rash, mouth sores, nail inflammation, dry skin, acne, decreased appetite, nausea, vomiting and itching. Your doctor may recommend some tips to help you if you experience any of these side effects.

Contact your doctor immediately if you experience any side effects that bother you, if they become serious, and/or affect your daily activities. Do not stop taking GILOTRIF unless advised by your doctor to do so.

What are the serious side effects associated with GILOTRIF?

In some cases, GILOTRIF can cause serious side effects. If such side effects occur, your doctor may interrupt your treatment and adjust your dose. In more severe cases, or after multiple dose adjustments, your doctor may choose to discontinue your treatment. While receiving GILOTRIF tell your doctor right away if you have any of the symptoms listed below.

  • Diarrhea. Diarrhea is common with GILOTRIF and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with GILOTRIF, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.
  • Skin reactions. GILOTRIF can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth.

    Limit your time in the sun. GILOTRIF can make your skin sensitive to the sun. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin while you are taking GILOTRIF if you have to be in sunlight.
  • Lung or breathing problems. GILOTRIF may cause inflammation of the lung that may lead to death. Tell your doctor right away if you have any new or worsening lung problems, or any combination of the following symptoms:
    • trouble breathing or shortness of breath
    • cough
    • fever
  • Liver problems. GILOTRIF can cause liver problems that can sometimes lead to death. Tell your doctor right away if you have any symptoms of a liver problem, which may include:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • dark or brown (tea colored) urine
    • pain on the upper right side of your stomach area (abdomen)
    • bleeding or bruising more easily than normal
    • feeling very tired

Your doctor will do blood tests to check your liver function during your treatment with GILOTRIF.

  • Eye problems. Symptoms may include:
    • eye pain, swelling, redness, or tearing
    • blurred vision
    • sensitivity to light
    • other changes in your vision
  • Heart problems. Symptoms may include:
    • new or worsening shortness of breath while at rest or with activity
    • cough
    • tiredness
    • swelling of your ankles, feet, or legs
    • feeling that your heart is pounding or racing (palpitations)
    • sudden weight gain

What can I do if I experience skin reactions when taking GILOTRIF?

Tell your doctor right away if you experience any skin reactions. GILOTRIF can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth.

Learn more about tips your doctor may recommend if you experience a skin reaction.

What can I do if I experience diarrhea when taking GILOTRIF?

Tell your doctor right away if you experience diarrhea. Diarrhea is common with GILOTRIF and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with GILOTRIF, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.

Learn more about what your doctor may recommend if you experience diarrhea as a side effect.

Is it okay to become pregnant or breastfeed while taking GILOTRIF?

GILOTRIF can harm your unborn baby. You should not become pregnant while taking GILOTRIF.

Women who are able to become pregnant should use effective birth control during treatment with GILOTRIF and for at least 2 weeks after your last dose of GILOTRIF. Talk to your doctor about birth control methods that may be right for you.

Tell your doctor right away if you become pregnant or think you are pregnant while taking GILOTRIF.

It is not known if GILOTRIF passes into your breast milk. Do not breastfeed while taking GILOTRIF and for 2 weeks after your last dose of GILOTRIF. Talk to your doctor about the best way to feed your baby if you take GILOTRIF..

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