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Taking TIBSOVO FOR CHOLANGIOCARCINOMA (CCA)

Before you take TIBSOVO

Tell your healthcare provider about all of your medical conditions, including if you:

  • Have any heart problems, including a condition called long QT syndrome
  • Have problems with abnormal electrolytes, such as sodium, potassium, calcium, or magnesium levels
  • Have nervous system problems
  • Have problems with your kidneys or are on dialysis
  • Have any liver disorders, including cirrhosis
  • Are pregnant or plan to become pregnant. TIBSOVO may cause harm to your unborn baby. You should avoid becoming pregnant during treatment with TIBSOVO. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with TIBSOVO
  • Are breastfeeding or plan to breastfeed. It is not known if TIBSOVO passes into your breast milk. Do not breastfeed during your treatment with TIBSOVO and for 1 month after your last dose of TIBSOVO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take hormonal contraceptives. TIBSOVO may affect how hormonal contraceptives work and may cause them to not work well.

How to take TIBSOVO

TIBSOVO is an oral medication you can take at home. Take TIBSOVO exactly as your healthcare provider tells you to.

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Take 2 tablets orally, once a day. Taking TIBSOVO at the same time as another daily activity, like when you brush your teeth, can help you remember.
Take TIBSOVO with or without food. Do not take TIBSOVO with a high-fat meal (about 1000 calories and 58 grams of fat).
Swallow TIBSOVO tablets whole. Do not split, crush, or chew the tablets.
If you miss a dose of TIBSOVO or did not take it at the usual time, take your dose as soon as possible and at least 12 hours before your next dose. Return to your normal schedule the following day. Do not take 2 doses of TIBSOVO within 12 hours. Do not change your dose or stop taking TIBSOVO without talking to your healthcare provider.
If you vomit after taking a dose of TIBSOVO, do not take an additional dose. Take your next dose at your usual time.

It's important to keep talking with your healthcare provider about your treatment plan and follow his or her instructions about treatment schedule and dose.

Information about the safe use of TIBSOVO

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take TIBSOVO for conditions for which it was not prescribed. Do not give TIBSOVO to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TIBSOVO that is written for healthcare professionals.

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How you should store TIBSOVO

  • Store TIBSOVO at room temperature between 68 to 77 °F (20-25 °C)
  • Keep TIBSOVO in the original container
  • Keep the container tightly closed with the desiccant canister (drying agent) inside to protect the tablets from moisture
  • Keep TIBSOVO and all medicines out of reach of children
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Possible side effects of TIBSOVO for cca

TIBSOVO may cause serious side effects, including:

  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats and can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint
  • Guillain-Barré syndrome has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of Guillain-Barré syndrome, including
    • Weakness or tingling feeling in your legs, arms, or upper body
    • Numbness and pain on one side or both sides of your body
    • Any changes in your ability to see, touch, hear, or taste
    • Burning or pricking sensation
    • Difficulty breathing

The most common side effects of TIBSOVO in adults with cholangiocarcinoma include:

  • Symptoms Icon Fever
    Fatigue
  • Symptoms Icon Cough
    Nausea
  • Symptoms Icon Trouble breathing
    Abdominal pain
  • Symptoms Icon Rash
    Diarrhea
  • Symptoms Icon Decreased Urination
    Cough
  • Dizziness or lightheadedness
    Hemoglobin
    decreased
    (anemia)
  • Symptoms icon rapid weight gain
    Decreased
    appetite
  • Symptoms icon swelling of your arms or legs
    Fluid and
    swelling in your
    stomach area
  • Symptoms icon swelling of your arms or legs
    Vomiting
  • Symptoms icon swelling of your arms or legs
    Changes in liver
    function tests
  • Symptoms icon swelling of your arms or legs
    Rash
Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if you develop certain side effects. TIBSOVO may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility. These are not all possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Talk with your healthcare provider about ways that may help you manage any side effects you may experience with TIBSOVO.

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FAQs
 
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What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with an isocitrate dehydrogenase-1 (IDH1) mutation with bile duct cancer (cholangiocarcinoma) that has spread and who have already received previous treatment(s).

Your healthcare provider will perform a test to make sure that TIBSOVO is right for you. It is not known if TIBSOVO is safe and effective in children.

 

IMPORTANT SAFETY INFORMATION

TIBSOVO may cause serious side effects, including:

  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) before and during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint
  • Guillain-Barré Syndrome. has happened in people treated with TIBSOVO. Your healthcare provider will monitor you for nervous system problems and will permanently stop your treatment with TIBSOVO if you develop Guillain-Barré syndrome. Tell your healthcare provider right away if you develop any signs or symptoms of Guillain-Barré syndrome, including:
  • weakness or tingling feeling in your legs, arms, or upper body
  • numbness and pain on one side or both sides of your body
  • any changes in your ability to see, touch, hear, or taste
  • burning or prickling sensation
  • difficulty breathing

The most common side effects of TIBSOVO in adults with cholangiocarcinoma include:

  • fatigue
  • nausea
  • abdominal pain
  • diarrhea
  • cough
  • decreased appetite
  • fluid and swelling in your stomach area
  • vomiting
  • Hemoglobin decreased (anemia)
  • rash
  • changes in liver function tests

Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if you develop certain side effects.

TIBSOVO may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking TIBSOVO, tell your healthcare provider about all of your medical conditions, including if you:

  • have any heart problems, including a condition called long QT syndrome
  • have problems with abnormal electrolytes, such as sodium, potassium, calcium, or magnesium levels
  • have nervous system problems
  • have problems with your kidneys or are on dialysis
  • have any liver disorders, including cirrhosis
  • are pregnant or plan to become pregnant. TIBSOVO can cause harm to your unborn baby. You should avoid becoming pregnant during treatment with TIBSOVO. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with TIBSOVO
  • are breastfeeding or plan to breastfeed. It is not known if TIBSOVO passes into your breast milk. Do not breastfeed during your treatment with TIBSOVO and for 1 month after your last dose of TIBSOVO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take hormonal contraceptives. TIBSOVO may affect how hormonal contraceptives work and may cause them to not work as well.

Please see Full Prescribing Information, including Medication Guide.

 

What is TIBSOVO?

TIBSOVO is a prescription medicine used to treat adults with an isocitrate dehydrogenase-1 (IDH1) mutation with bile duct cancer (cholangiocarcinoma) that has spread and who have already received previous treatment(s).

Your healthcare provider will perform a test to make sure that TIBSOVO is right for you. It is not known if TIBSOVO is safe and effective in children.

IMPORTANT SAFETY INFORMATION

TIBSOVO may cause serious side effects, including:

  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider will check the electrical activity of your heart with a test called an electrocardiogram (ECG) before and during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint

IMPORTANT SAFETY INFORMATION