Important questions to ask your healthcare provider

It is important to take an active role in your treatment. One of the best ways you can do this is to talk with your healthcare providers. This can help you feel more confident about your treatment with TIBSOVO®. Some important questions to ask are:

  • What makes TIBSOVO right for me?

  • What should I expect while taking TIBSOVO?

  • Is there anything I should avoid
    while taking TIBSOVO?

  • How do I take TIBSOVO, and
    what if I miss a dose?

  • Is it safe for me to take TIBSOVO
    while on other medications?

  • How should I store TIBSOVO?

Ask every question. Talk with your healthcare provider so you can understand any questions regarding your diagnosis and treatment.

ServierONE Patient Support Services

ServierONE Patient Support Services will work with you, your caregiver, and your healthcare provider(s) to help you get treatment after you've been prescribed TIBSOVO.

Financial assistance may be available, no matter your insurance type or status.a

Your healthcare provider or ServierONE Patient Support Services can help figure out which financial assistance program is right for you.

For more information, please visit ServierONE.com or call 1-800-813-5905.

Commercial/private Insurance

What does it mean?

You get your health insurance through your work or your spouse’s work, or you purchase it yourself.

The program(s) for you

Commercial Co-Pay Program This program can help lower out-of-pocket costs. There are no income restrictions, and it is available to eligible patients with commercial/private insurance. For more information on the co-pay program, go to www.ServierONE-copay.com. Note: If you have government insurance, you are not eligible for this program.

Government Insurance

What does it mean?

You get your health insurance through a government healthcare insurance program such as Medicare, Medicaid, Medigap, Tricare, Veterans Affairs (VA), Department of Defense (DoD), or any state-funded programs.

The program(s) for you

Independent foundationsb Independent foundations may be available to help you pay for TIBSOVO. One of our specialty pharmacies or ServierONE can provide a referral to these foundations.

Uninsured or underinsured

What does it mean?

You have no insurance coverage or lack coverage for your prescribed therapy.

The program(s) for you

Patient Assistance Program (PAP) The PAP may help you get access to TIBSOVO. Income requirements apply. You and your healthcare provider can reach out to ServierONE to learn more.

Commercial/private Insurance
What does it mean? You get your health insurance through your work or your spouse’s work, or you purchase it yourself.
The program(s) for you Commercial Co-Pay Program This program can help lower out-of-pocket costs. There are no income restrictions, and it is available to eligible patients with commercial/private insurance. For more information on the co-pay program, go to www.ServierONE-copay.com. Note: If you have government insurance, you are not eligible for this program.
Government Insurance
What does it mean? You get your health insurance through a government healthcare insurance program such as Medicare, Medicaid, Medigap, Tricare, Veterans Affairs (VA), Department of Defense (DoD), or any state-funded programs.
The program(s) for you Independent foundationsb Independent foundations may be available to help you pay for TIBSOVO. One of our specialty pharmacies or ServierONE can provide a referral to these foundations.
Uninsured or underinsured
What does it mean? You have no insurance coverage or lack coverage for your prescribed therapy.
The program(s) for you Patient Assistance Program (PAP) The PAP may help you get access to TIBSOVO. Income requirements apply. You and your healthcare provider can reach out to ServierONE to learn more.

Please see ServierONE.com for full Terms and Conditions for each program.

aIf you are waiting for coverage, you may be eligible for a free product program. Contact ServierONE for more information.

bEligibility is determined by the individual foundation. Servier Pharmaceuticals is not affiliated with these organizations.

Independent foundations may also provide support to patients. Your ServierONE care manager team can provide more information.

For more information about Servier Pharmaceuticals, visit Servier.us.

Patient Advocacy, Support, and Assistancec

  • AA.MDS International Foundation (AAMDSIF)
  • 1-800-747-2820

cThese are independent resources. Servier Pharmaceuticals is not affiliated with these organizations.

Tools that can help

The downloadable materials below may be helpful to you and your healthcare team.

  • patient brochure

    TIBSOVO AML Patient Brochure

    Your guide to IDH1-targeted treatment with TIBSOVO.

    Download
  • TIBSOVO dosing calendar

    TIBSOVO Dosing Calendar

    Use this TIBSOVO dosing calendar to ensure you are taking every dose

    Download
  • Differentiation syndrome reference card

    Differentiation Syndrome Reference Card

    This card can help you let your healthcare providers know that you are taking a medication that can cause differentiation syndrome. Fill it out and keep it with you at all times. Be sure to show it to any person involved in your medical care.

    Download
  • Medication guide

    Medication Guide

    Important things to know about taking TIBSOVO.

    Download
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What is TIBSOVO?

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

  • adults with newly diagnosed AML treated in combination with TIBSOVO and azacitidine who are 75 years or older or who have health problems that prevent the use of certain chemotherapy treatments
  • 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 in AML Patients. Differentiation syndrome is a common condition, which can be serious, that affects your blood cells and may be life-threatening or lead to death. Differentiation syndrome in adults with acute myeloid leukemia (AML) 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 when used in combination with azacitidine or alone in adults with AML include:

  • changes in certain blood cell counts
  • diarrhea
  • increased blood sugar
  • fatigue
  • changes in certain liver function tests
  • swelling of arms or legs
  • decreased levels of electrolytes in the blood
  • nausea
  • vomiting
  • decreased appetite
  • joint pain
  • shortness of breath
  • uric acid increased
  • stomach (abdominal) pain
  • changes in certain kidney function tests
  • pain or sores in your mouth or throat
  • rash
  • irregular heart rhythm or heartbeat (QTc prolongation)
  • differentiation syndrome
  • muscle pain

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 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 doctor 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 BOXED WARNING for AML patients and Medication Guide.

 

What is TIBSOVO?

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

  • adults with newly diagnosed AML treated in combination with TIBSOVO and azacitidine 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 in AML Patients. Differentiation syndrome is a common condition, which can be serious, that affects your blood cells and may be life-threatening or lead to death. Differentiation syndrome in adults with acute myeloid leukemia (AML) 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:

IMPORTANT SAFETY INFORMATION