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Generic Name: ivosidenib
Dosage Form: Tablets
Date of Approval: July 20, 2018
Company: Agios Pharmaceuticals, Inc.

Treatment for: Acute Myeloid Leukemia

Medically reviewed on Jul 31, 2018

FDA Approves Tibsovo

The U.S. Food and Drug Administration has approved Tibsovo (ivosidenib), an isocitrate dehydrogenase-1 (IDH1) inhibitor for the treatment of patients with relapsed or refractory acute myeloid leukemia with an IDH1 mutation.

Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important 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 one day and up to three 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:
    • fever
    • cough
    • trouble breathing
    • rash
    • decreased urination
    • dizziness or lightheadedness
    • rapid weight gain
    • swelling of your arms or 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.

See Tibsovo side effects for more information about side effects.

What is Tibsovo?

Tibsovo 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 this medicine is safe and effective in children.

Before taking Tibsovo

Before you start treatment, 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, or magnesium levels.
  • have nervous system problems.
  • are pregnant or plan to become pregnant. Tibsovo may cause harm to your unborn baby. You should avoid becoming pregnant during treatment. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during your treatment, and for at least one month after your last dose.

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.

How should I take Tibsovo?

  • Take Tibsovo exactly as your healthcare provider tells you to. Do not adjust dose or stop treatment without talking to your healthcare provider.
  • Take Tibsovo one time a day about the same time each day.
  • Swallow the tablets whole. Do not split, crush, or chew the tablets.
  • The tablets can be taken with or without food.
  • Do not take Tibsovo with a high-fat meal. An example of a high-fat meal includes two eggs fried in butter, two strips of bacon, two slices of white bread with butter, one croissant with one slice of cheese, and 8 ounces of whole milk (approximately 1,000 calories and 58 grams of fat).
  • If you vomit after taking your dose, do not take an additional dose. Take your next dose at your usual time.
  • If you miss a dose 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 two doses of Tibsovo within 12 hours.

Tibsovo side effects

Tibsovo may cause serious side effects, including:

  • See Important information.
  • 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 your treatment. 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 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 include:

  • fatigue
  • high white blood cell count
  • joint pain
  • diarrhea
  • shortness of breath
  • swelling of arms or legs
  • nausea
  • pain or sores in your mouth or throat
  • irregular heart rhythm or heartbeat (QTc prolongation)
  • fever
  • cough
  • low red blood cell count (anemia)
  • constipation

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 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. 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 Tibsovo?

  • Store Tibsovo at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of the reach of children and pets.

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 this medicine for conditions for which it was not prescribed. Do not give it 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 that is written for healthcare professionals.

What are the ingredients in Tibsovo?

Active ingredient: ivosidenib

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet coating includes FD&C blue #2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.