$idhifa (enasidenib) for relapsed refractory aml with an idh2 mutation$

How should I take IDHIFA®?

IDHIFA® is an oral medication that you can take at home

Take IDHIFA® exactly as your healthcare provider tells you to

Take IDHIFA® 1 time a day at the same time each day

Swallow IDHIFA® tablets whole with 8 ounces (1 cup) of water. Do not chew or split the tablet

IDHIFA® can be taken with or without food

If you miss a dose of IDHIFA® or vomit after taking a dose of IDHIFA®, take the dose of IDHIFA® as soon as possible on the same day. Then take your next dose the next day at your regularly scheduled time. Do not take 2 doses at the same time to make up for the missed dose
Your healthcare provider should do blood tests to check your blood counts before you start IDHIFA® treatment and at a minimum of every 2 weeks for at least the first 3 months during treatment to check for side effects

How long should I take IDHIFA®?

In the clinical trial, half of the 214 patients evaluated for safety took IDHIFA® for more than 4.3 months, while half took it for less than that (range of 0.3 months to 23.6 months)
In patients evaluated for efficacy and for whom IDHIFA® worked (46 out of 199) the amount of time it took to see a response varied:
- Half of patients saw their first response after taking IDHIFA® for 1.9 months (range of 0.5 months to 7.5 months), while for half it took longer
- Half of patients saw their best response after taking IDHIFA® for 3.7 months (range of 0.6 months to 11.2 months), while for half it took longer
Your doctor will decide how long you will take IDHIFA®, so be sure to follow his or her instructions about treatment schedule and dose

How should I store IDHIFA®?

Store IDHIFA® at temperatures of 68°F to 77°F (20°C to 25°C)
Keep IDHIFA® in the original container
Keep the container tightly closed with desiccant canister (drying agent) inside to protect the tablets from moisture

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:

100 mg

50 mg

What are the possible benefits of IDHIFA®?

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.

IDHIFA® helped patients achieve different levels of response.

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.

Achieved A CR

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.

Achieved A CRh

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.

IDHIFA® helped reduce the need for red blood cell or platelet transfusions.

idhifa reduced the need for transfusions

34 percent of idhifa patients became transfusion free

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.

76 percent of idhifa patients remained transfusion free

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.

What are the possible side effects of IDHIFA®?

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®:
- Fever
- Cough
- Shortness of breath
- Swelling of arms and legs
- Swelling around neck, groin, or underarm area
- Fast weight gain (greater than 10 pounds within a week)
- Bone pain

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:

Nausea
Vomiting
Diarrhea
Jaundice
Decreased appetite

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.

Your healthcare provider will monitor you for side effects during treatment and may tell you to stop taking IDHIFA® if you develop certain side effects
- Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

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 SECTION

WHAT IS IDHIFA® (enasidenib)?

IDHIFA® is a prescription medicine used to treat people with acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation whose disease has come back or has not improved after previous treatment(s). It is not known if IDHIFA is safe and effective in children.

Toggle Toggle

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IDHIFA?

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:
- fever
- cough
- shortness of breath
- swelling of arms and legs
- swelling around neck, groin, or underarm area
- fast weight gain (greater than 10 pounds within a week)
- bone pain

Toggle

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

Are pregnant, plan to become pregnant, or think you might be pregnant during treatment with IDHIFA. IDHIFA can cause harm to your unborn baby if taken during pregnancy
- If you are able to become pregnant, your healthcare provider will do a pregnancy test before you start taking IDHIFA
- Females who are able to become pregnant and who take IDHIFA should use effective birth control (contraception) during treatment with IDHIFA and for at least 2 months after your last dose of IDHIFA
- Males who have female partners that are able to become pregnant should use effective birth control during treatment with IDHIFA and for at least 2 months after your last dose of IDHIFA
- IDHIFA may affect how hormonal contraceptives work and may cause them to not work as well
- Talk to your healthcare provider about birth control methods that may be right for you while taking IDHIFA
- IDHIFA 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
Are breastfeeding or plan to breastfeed. It is not known if IDHIFA passes into your breast milk. You should not breastfeed during your treatment with IDHIFA and for at least 2 months after your last dose of IDHIFA

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

How should I take IDHIFA?

Take IDHIFA exactly as your healthcare provider tells you to
Take IDHIFA 1 time a day at the same time each day. IDHIFA can be taken with or without food
Swallow IDHIFA tablets whole with 8 ounces (one cup) of water. Do not chew or split the tablet
If you miss a dose of IDHIFA or vomit after taking a dose of IDHIFA, take the dose of IDHIFA as soon as possible on the same day. Then take your next dose the next day at your regularly scheduled time. Do not take 2 doses at the same time to make up for the missed dose
Your healthcare provider should do blood tests to check your blood counts before you start IDHIFA treatment and at a minimum of every 2 weeks for at least the first 3 months during treatment to check for side effects

What are the possible side effects of IDHIFA?

IDHIFA may cause serious side effects, including:

See "What is the most important information I should know about IDHIFA?"

The most common side effects of IDHIFA include:

nausea
vomiting
diarrhea
jaundice
decreased appetite

Tell your healthcare provider if you have any changes to the color of your skin or the whites of your eyes.

Your healthcare provider will monitor you for side effects during treatment and may tell you to stop taking IDHIFA if you develop certain side effects. These are not all the possible side effects of IDHIFA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

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.

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