Patient Education Guide
For more information on how to take REZLIDHIA, download the Patient Education Guide.
Taking REZLIDHIA
HOW DO I TAKE REZLIDHIA?
REZLIDHIA offers convenient oral dosing and is taken twice a day.
REZLIDHIA should be taken:
By mouth
On an empty stomach
2 times a day
- DO take 1 capsule of REZLIDHIA twice a day around the same time each day, about 12 hours apart.
- DO take REZLIDHIA 1 hour before or 2 hours after a meal.
- DO swallow REZLIDHIA capsules whole.
- DO NOT take 2 capsules within 8 hours.
- DO NOT break, open, or chew REZLIDHIA.
- DO NOT stop or change your dose without talking to your healthcare provider.
Always take REZLIDHIA exactly as your healthcare provider tells you to. Responses may vary. People who achieved a complete remission or complete remission with partial hematologic recovery (CR/CRh) did so within their first 6 months of treatment. Your healthcare provider should know after 6 months if REZLIDHIA is working for you.
WHAT IF I MISS A DOSE?
If you miss a dose or didn’t take REZLIDHIA at your usual time:
- Take your dose as soon as possible and at least 8 hours before your next dose
- Return to your normal schedule the following day
If you vomit after taking a dose of REZLIDHIA:
- Do not take another dose
- Take your next dose at your usual time
MONITORING
While taking REZLIDHIA, your healthcare provider will run blood tests to monitor your health. During treatment, your healthcare provider may change how often the tests are needed.
Your healthcare provider will monitor your condition for signs of differentiation syndrome, liver problems, and possible serious side effects of treatment.
STAYING ON TOP OF YOUR TREATMENT
It’s important to be consistent with taking REZLIDHIA. Here are some tips for successful dosing with REZLIDHIA:
- Add REZLIDHIA to your current routine when you have an empty stomach
- Set alarms on your device to remind you when you’re supposed to take REZLIDHIA
- Get a pill box from your pharmacy that has labels for both the days of the week and “AM/PM,” so you know when you’re supposed to take REZLIDHIA
- Ask for support! Letting friends, family, or caregivers know about your treatment plan can help add an extra layer of accountability
BEFORE STARTING REZLIDHIA
Before starting treatment, talk to your healthcare provider about all 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
REZ_AML-23076 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.