Differentiation Syndrome Pocket Card
Download the Differentiation Syndrome Pocket Card to carry with you and share with healthcare providers or emergency responders should you have signs and symptoms of differentiation syndrome.
WHAT TO EXPECT WITH REZLIDHIA
HOW WAS REZLIDHIA STUDIED?
In the clinical trial of REZLIDHIA
147 adults with relapsed or refractory AML with an IDH1 mutation
Received REZLIDHIA treatment 150 mg twice a day by mouth
Until their healthcare provider discontinued treatment due to stem cell transplant, side effects, or worsening of their AML
Defining success in the REZLIDHIA trial
The goal of AML treatment is to achieve remission—success with REZLIDHIA was measured by the number of people who went into remission.
Complete remission (CR) means there were no signs of cancer and lab values returned to normal.
Complete remission with partial hematologic recovery (CRh) means there were no signs of cancer, but some lab values did not completely return to normal.
There are other types of responses to REZLIDHIA beyond CR or CRh. These include CR with incomplete recovery (CRi), partial response (PR), and morphologic leukemia–free state (MLFS). These “other responses” are also considered clinically meaningful.
WHAT ARE THE CLINICAL BENEFITS OF REZLIDHIA?
Almost half of people taking REZLIDHIA had a clinically meaningful response
35% of people taking REZLIDHIA achieved CR/CRh.
Long-term response
Half of people who achieved CR/CRh stayed in remission for over 26 months.
Estimated survival
~8 out of 10 people who achieved CR/CRh with REZLIDHIA were estimated to be alive after 18 months.
Early response
People who responded to REZLIDHIA did so as early as 1 month and up to 6 months. Half of people responded in the first 2 months.
Reduced need for transfusions
34% of people who required transfusions at the start of the clinical trial became transfusion free for at least 8 weeks.
Transplant potential
11% of people underwent a stem cell transplant following treatment with REZLIDHIA.
WHAT ARE THE POSSIBLE SIDE EFFECTS?
Everyone responds differently to treatment. During the REZLIDHIA trial, some side effects did occur, of which some were serious, resulting in dose adjustments or treatment discontinuation. It’s important to review the possible side effects with your healthcare provider before starting treatment.
REZLIDHIA may cause differentiation syndrome
Blood cells form through a process called differentiation. If this happens too quickly with AML treatment, differentiation syndrome can occur and may be life threatening or lead to death. Differentiation syndrome in adults with AML has occurred as early as 1 day and up to 18 months after starting REZLIDHIA.
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 REZLIDHIA:
- Fever
- Cough
- Trouble breathing
- Decreased urination
- Dizziness or lightheadedness
- Weight gain
- Swelling in your arms or legs
If you develop differentiation syndrome, your healthcare provider may choose to monitor you in the hospital and will provide appropriate treatment.
REZLIDHIA may cause liver problems
Changes in liver function tests are common during treatment with REZLIDHIA and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with REZLIDHIA.
Tell your healthcare provider right away if you develop any of the following symptoms of liver problems during treatment with REZLIDHIA:
- Yellowing of your skin or the white part of your eyes (jaundice)
- Dark “tea-colored” urine
- Loss of appetite
- Pain on the upper right side of your stomach area
- Feeling very tired or weak
The most common side effects of REZLIDHIA include:
- Abnormal liver function tests
- Nausea
- Feeling tired or unwell
- Joint pain
- Constipation
- Shortness of breath
- Fever
- Rash
- Mouth sores
- Diarrhea
- Changes in certain blood tests
Tell your healthcare provider if you have any nausea, constipation, diarrhea, vomiting, stomach pain, or mouth sores.
Your healthcare provider will do blood tests before you start and during treatment with REZLIDHIA. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with REZLIDHIA if you develop certain side effects. These are not all the possible side effects of REZLIDHIA.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
REZ_AML-23075 0723
What is REZLIDHIA?
REZLIDHIA is a prescription medicine used to treat adults with acute myeloid leukemia (AML) with 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 REZLIDHIA is right for you.
It is not known if REZLIDHIA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
REZLIDHIA 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. Differentiation syndrome in adults with acute myeloid leukemia (AML) has occurred as early as 1 day and up to 18 months after starting REZLIDHIA. 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 REZLIDHIA:
- fever
- cough
- trouble breathing
- decreased urination
- dizziness or lightheadedness
- 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.
Liver problems. Changes in liver function tests are common during treatment with REZLIDHIA and can be serious. Your healthcare provider will do blood tests to check your liver function before and during treatment with REZLIDHIA. Tell your healthcare provider right away if you develop any of the following symptoms of liver problems during treatment with REZLIDHIA:
- yellowing of your skin or the white part of your eyes (jaundice)
- dark “tea-colored” urine
- loss of appetite
- pain on the upper right side of your stomach area
- feeling very tired or weak
The most common side effects of REZLIDHIA in adults with AML include:
- abnormal liver function tests
- nausea
- feeling tired or unwell
- joint pain
- constipation
- shortness of breath
- fever
- rash
- mouth sores
- diarrhea
- changes in certain blood tests
Tell your healthcare provider if you have any nausea, constipation, diarrhea, vomiting, stomach pain or mouth sores.
Your healthcare provider will do blood tests before you start and during treatment with REZLIDHIA. Your healthcare provider may decrease, temporarily hold, or permanently stop your treatment with REZLIDHIA if you develop certain side effects. These are not all the possible side effects of REZLIDHIA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking REZLIDHIA, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems.
- are pregnant or plan to become pregnant. REZLIDHIA may harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if REZLIDHIA passes into your breast milk. Do not breastfeed during your treatment with REZLIDHIA and for 2 weeks after your last dose of REZLIDHIA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Click here for Full Prescribing Information, including Boxed WARNING and Medication Guide.