"The US Food and Drug Administration (FDA) today granted accelerated approval for osimertinib (Tagrisso, AstraZeneca), previously known as AZD9291, for the treatment of a specific type of advanced non-small-cell lung cancer.
Read this Patient Information before you start taking GILOTRIF and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
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, and
- who 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 children.
What should I tell my doctor before taking 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 while taking GILOTRIF.
- are breastfeeding or plan to breastfeed. It is not known if GILOTRIF passes into your breast milk. You and your doctor should decide if you will take GILOTRIF or breastfeed. You should not do both.
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.
Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.
How should 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 GILOTRIF unless your doctor tells you to.
- Take GILOTRIF on an empty stomach at least 1 hour before a meal or 2 hours after a meal.
- 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.
What should I 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.
What are the possible side effects of GILOTRIF?
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.
- lung or breathing problems. Tell your doctor right
away if you have any new or worsening lung problems, or any combination of the
- trouble breathing or shortness of breath
- liver problems. 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 which 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 symptoms of a heart problem which may include:
- new or worsening shortness of breath while at rest or with activity
- 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:
- mouth sores
- nail infection
- dry skin
- decreased appetite
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 may report side effects to FDA at 1-800-FDA-1088.
How should I store GILOTRIF?
- Store GILOTRIF at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep GILOTRIF in the original container and keep the container tightly closed.
- Keep GILOTRIF away from moisture and light.
- Safely throw away (discard) any GILOTRIF that is out of date or no longer needed.
Keep GILOTRIF and all medicines out of the reach of children.
General information about GILOTRIF
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GILOTRIF for a condition for which it was not prescribed. Do not give GILOTRIF to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information summarizes the most important information about GILOTRIF. If you would like more information about GILOTRIF, talk with your doctor. You can ask your doctor or pharmacist for information about GILOTRIF that is written for health professionals.
For more information, go to www.gilotrif.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or (TTY) 1-800-459-9906, or scan the code below to go to www.gilotrif.com.
What are the ingredients in GILOTRIF?
Active ingredient: afatinib
Inactive ingredients: Tablet Core: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate. Tablet Coating: hypromellose, polyethylene glycol, titanium dioxide, talc, polysorbate 80, FD&C Blue No. 2 (40 mg and 30 mg tablets only).
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 11/23/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Gilotrif Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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