For questions about BMS medicines during this time please call 1-800-721-8909.
IDHIFA® is an oral medication that you can take at home
Keep IDHIFA® and all medicines out of reach of children.
Keep IDHIFA® and all medicines out of reach of children.
General information about the safe and effective use of IDHIFA®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take IDHIFA® for conditions for which it was not prescribed. Do not give IDHIFA® 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 IDHIFA® that is written for health professionals.
Keep IDHIFA® in the bottle it was prescribed in. Do not transfer IDHIFA® to a pill sorter or other container
IDHIFA® is available in 2 tablet strengths:
A clinical trial was done to determine the effectiveness and safety of IDHIFA® in patients with relapsed or refractory AML with an IDH2 mutation. To study the effectiveness of IDHIFA®, 199 patients were started on the 100-mg oral dose of IDHIFA® every day until disease progression or unacceptable toxicity. Dose reductions were allowed to manage side effects.
Nearly
1 in 4 patients
(46 out of 199, or 23%)
responded to IDHIFA® treatment
Achieving a “response” means that IDHIFA® helped patients achieve a complete remission (CR) or complete remission with partial hematologic recovery (CRh). A CR occurs when a patient’s blood counts and bone marrow return to normal. A CRh means that no signs of the cancer were seen, but certain blood counts did not completely return to normal.
Half of patients who achieved a CR saw the benefit of IDHIFA® last for more than 8.2 months, while half saw the benefit last for less than that.
Half of patients who achieved a CRh saw the benefit of IDHIFA® last for more than 9.6 months, while half saw the benefit last for less than that.
More than
1 in 3 patients
(53 out of 157, or 34%)
became transfusion free.
This means that patients who needed red blood cell and/or platelet transfusions when the clinical trial began became transfusion free for a period of 8 weeks or more.
32 out of 42
patients (76%) remained
transfusion free.
This means that patients who did not need red blood cell and/or platelet transfusions when the clinical trial began remained transfusion free for a period of 8 weeks or more.
To study the safety of IDHIFA®, 214 patients with relapsed or refractory AML with an IDH2 mutation were assigned to receive the 100-mg oral dose of IDHIFA® every day and were monitored for the appearance of side effects.
You may experience side effects while taking IDHIFA®. In the clinical trial, 92 out of 214 patients (43%) had their dose of IDHIFA® interrupted, 10 out of 214 patients (5%) had their dose reduced, and 36 out of 214 patients (17%) had their dose discontinued due to side effects.
IDHIFA® may cause serious side effects, including:
Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells which may be life-threatening or lead to death if not treated. Differentiation syndrome has happened within 1 day and up to 5 months after starting IDHIFA®. 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 IDHIFA®:
If you develop any of these symptoms of differentiation syndrome, your healthcare provider may start you on a medicine taken by mouth or given through a vein (intravenous) called corticosteroids and may monitor you in the hospital.
The most common side effects of IDHIFA® include:
Tell your healthcare provider if you have any changes to the color of your skin or the whites of your eyes.
These are not all the possible side effects of IDHIFA®. Tell your doctor if you are experiencing any of the side effects listed on this page.
To learn more about serious side effects and how they may affect you, speak with your healthcare team or refer to the Medication Guide.
Access downloadable PDFs and find additional information and tools for your treatment and disease.
VISIT OUR RESOURCES SECTIONPlease choose an option:
Visit Healthcare Professional SiteThe information contained in this website is intended for U.S. audiences only.