Possible side effects of TIBSOVO®

Learn more: Differentiation syndrome

Blood cells form through a process called differentiation. Some treatments for AML, including TIBSOVO, can cause differentiation to happen too fast. This is called differentiation syndrome.

Differentiation syndrome is serious and may be life-threatening if not treated. Differentiation syndrome has happened as early as 1 day and up to 3 months after starting TIBSOVO.

Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the symptoms of differentiation syndrome listed below.

1 in 4 people with newly diagnosed AML who took TIBSOVO (7 out of 28) experienced differentiation syndrome.

About 1 in 5 people with relapsed or refractory AML who took TIBSOVO (34 out of 179) experienced differentiation syndrome.

Contact your healthcare provider right away if you have any of the following symptoms of differentiation syndrome:
  • Symptoms Icon Fever
    Fever
  • Symptoms Icon Cough
    Cough
  • Symptoms Icon Trouble breathing
    Trouble breathing
  • Symptoms Icon Rash
    Rash
  • Symptoms Icon Decreased Urination
    Decreased
    urination
  • Dizziness or lightheadedness
    Dizziness or lightheadedness
  • Symptoms icon rapid weight gain
    Rapid
    weight gain
  • Symptoms icon swelling of your arms or legs
    Swelling of your
    arms or legs

If you have differentiation syndrome, your healthcare provider may give you steroids or other medications and monitor you in the hospital.

It is important to let all of your healthcare providers know that you are taking a medication that can cause differentiation syndrome. The Differentiation Syndrome Reference Card can help. Print out the card, fill it out, and keep it with you at all times. Be sure to show it to any person involved in your medical care.

TIBSOVO may cause serious side effects, including:

  • Differentiation syndrome, which may be life-threatening or lead to death if not treated
  • Changes in the electrical activity of your heart called QTc prolongation. QTc prolongation can cause irregular heartbeats and can be life-threatening. Tell your doctor right away if you feel dizzy, lightheaded, or faint
  • 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; or difficulty breathing

Your healthcare provider will do blood tests before you start and during treatment with TIBSOVO.


Be sure to tell your healthcare provider right away about any side effects you have. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with TIBSOVO if you develop side effects.

To study the safety of TIBSOVO, 213 adults with AML with an IDH1 mutation were assigned to receive TIBSOVO 500 mg every day and were monitored for the appearance of side effects.

The most common side effects of TIBSOVO include:

    • fatigue
    • joint pain
    • high white blood cell count
    • diarrhea
    • swelling of arms or legs
    • nausea
    • shortness of breath
    • pain or sores in your mouth or throat
    • irregular heart rhythm or heartbeat (QTc prolongation)
    • rash
    • cough
    • decreased appetite
    • muscle pain
    • constipation
    • fever
    • hemoglobin decreased (anemia)
    • decreased levels of electrolytes in the blood
    • changes in liver or kidney function tests

These are not all the possible side effects of TIBSOVO. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA (U.S. Food & Drug Administration) at 1-800-FDA-1088.

What to do if you experience side effects

You should always tell your healthcare provider about any side effects you have. They may be able to prescribe medicines to help you manage them. However, there are some things you can do on your own that may help, too.

Rash

  • Avoid the sun (especially between 10 am and 4 pm), wear a broad-brimmed hat, and use sunscreen with an SPF of 15 or higher
    • If the sunscreen stings or burns, try one with zinc oxide or titanium dioxide
  • Shower with lukewarm (not hot) water and use a mild soap
  • Apply a cream-based moisturizer to all skin within 5 minutes of showering or bathing
    • Use a hypoallergenic moisturizer that does not have perfumes or preservatives
  • Avoid skin products containing alcohol or retinoids, which can dry out your skin
  • Avoid laundry detergent with strong perfumes

Rash may be a symptom of differentiation syndrome, so it is important to speak with your healthcare provider right away if you have a rash.

Nausea

  • If nausea only happens between meals, eat frequent small meals and have a snack at bedtime
    • Do not take TIBSOVO with a high-fat meal (about 1000 calories and 58 grams of fat)
  • Drink clear liquids served cold and sipped slowly
  • Eat bland foods (dry toast and crackers)
  • Eat food cold or at room temperature
  • Avoid fatty, fried, spicy, or very sweet foods
  • Rest quietly while sitting upright for at least an hour after each meal
  • Distract yourself with music, TV, or company

Diarrhea

  • Eat small meals often
  • Avoid acidic drinks (tomato or citrus juices, fizzy soft drinks); hot, spicy, or greasy foods; bran; raw fruits and vegetables; pastries; candies; rich desserts; jellies; preserves; and nuts
  • Avoid caffeine, alcohol, and tobacco
  • Avoid milk or milk products if they make diarrhea worse
  • Try a clear liquid diet as soon as diarrhea starts or when you feel it’s going to start
  • When diarrhea starts to improve, try eating small amounts of foods that are easy to digest (rice, bananas, applesauce, yogurt, mashed potatoes, low-fat cottage cheese, dry toast). If diarrhea continues to improve after a day or 2, start small, regular meals

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

Taking TIBSOVO

Take 2 tablets orally, once a day

Tibsovo pills dosage

Tablets not shown at actual size.

  • Do not adjust your dose or stop taking TIBSOVO without talking to your healthcare provider

Before taking TIBSOVO

  • Tell your healthcare provider about all of your medical conditions, including if you have any heart problems, have problems with abnormal electrolytes, 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, are breastfeeding or plan to breastfeed
  • 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
While taking TIBSOVO
Take TIBSOVO 1 time a day
Take TIBSOVO 1 time a day at about the same time each day.
Taking it at the same time as another daily activity, like brushing your teeth, can help you remember.
Dosage icon with food
Take TIBSOVO with or without food.
Do not take TIBSOVO with a high-fat meal (about 1000 calories and 58 grams of fat).
Dosage icon swallow whole
Swallow TIBSOVO tablets whole.
Do not split, crush, or chew the tablets.
Dosage icon if you miss a dose
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.

If you vomit after taking a dose of TIBSOVO, do not take an additional dose. Take your next dose at your usual time.

How to store TIBSOVO

  • Store TIBSOVO at room temperature (68°F to 77°F)
  • Keep TIBSOVO in the original container
  • Keep TIBSOVO and all medicines out of reach of children

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.

What to expect with TIBSOVO

Remember that TIBSOVO works differently than traditional chemotherapy. Because of this, there are some important things to be aware of during treatment.

  • Take TIBSOVO exactly as your healthcare provider tells you to. TIBSOVO can take time to work. So if your AML does not progress and you do not have side effects you cannot tolerate, your healthcare provider will keep you on TIBSOVO for at least 6 months
  • TIBSOVO may cause serious side effects, including differentiation syndrome. Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the symptoms of differentiation syndrome while taking TIBSOVO. For a list of these symptoms, click here
 
 

What is TIBSOVO?

TIBSOVO (ivosidenib) is a prescription medicine used to treat acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation in:

  • adults with newly diagnosed AML who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments.
  • adults with AML when the disease has come back or has not improved after 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:

  • Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated. Differentiation syndrome has happened as early as 1 day and up to 3 months after starting TIBSOVO. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome during treatment with TIBSOVO:
    • fever
    • cough
    • trouble breathing
    • rash
    • decreased urination
    • dizziness or lightheadedness
    • rapid weight gain
    • swelling of your arms and legs

If you develop signs and symptoms of differentiation syndrome, your healthcare provider may treat you with a corticosteroid medicine or a medicine called hydroxyurea and may monitor you in the hospital.

  • 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) during treatment with TIBSOVO. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint.
  • Guillain-Barré Syndrome. 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 include:

    • fatigue
    • joint pain
    • high white blood cell count
    • diarrhea
    • swelling of arms or legs
    • nausea
    • shortness of breath
    • pain or sores in your mouth or throat
    • irregular heart rhythm or heartbeat (QTc prolongation)
    • rash
    • cough
    • decreased appetite
    • muscle pain
    • constipation
    • fever
    • hemoglobin decreased (anemia)
    • decreased levels of electrolytes in the blood
    • changes in liver or kidney 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 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 the possible side effects of TIBSOVO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 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 at least 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 doctor if you take hormonal contraceptives. TIBSOVO may affect how hormonal contraceptives work and may cause them to not work as well.

Taking TIBSOVO

  • Take TIBSOVO exactly as your healthcare provider tells you to.
  • Do not change your dose or stop taking TIBSOVO without talking to your healthcare provider.
  • Take TIBSOVO 1 time a day about the same time each day.
  • Swallow TIBSOVO tablets whole. Do not split, crush, or chew the tablet.
  • TIBSOVO can be taken with or without food. Do not take TIBSOVO with a high-fat meal.
  • If you vomit after taking a dose of TIBSOVO, do not take an additional dose. Take your next dose at your usual time.
  • 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.

General information about the safe and effective 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.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide.

 

What is TIBSOVO?

TIBSOVO (ivosidenib) is a prescription medicine used to treat adults with acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-1 (IDH1) mutation when the disease has come back or has not improved after 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:

  • Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells and may be life-threatening or lead to death if not treated. Differentiation syndrome has happened as early as 1 day and up to 3 months after starting TIBSOVO. Call your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following symptoms of differentiation syndrome while taking TIBSOVO