This site uses cookies to give you a better experience. By clicking “Accept,” you consent that you agree to our Privacy Policy.

INREBIC® (fedratinib) is a prescription medicine used to treat adults with certain types of myelofibrosis (MF). It is not known if INREBIC is safe and effective in children.

About INREBIC

patient and caregiver

On this page:

    Who is INREBIC for?

    INREBIC is a prescription medicine used to treat adults with primary or secondary intermediate-2 or high-risk myelofibrosis (MF).

    How was INREBIC clinically studied?

    The clinical trial of INREBIC was called JAKARTA. The JAKARTA study looked at whether INREBIC was safe and effective in treating adult patients with primary or secondary intermediate-2 or high-risk MF with splenomegaly.

    The study included 289 patients who had intermediate-2 or high-risk primary or secondary myelofibrosis. INREBIC users were compared with a group given a placebo. In the study, 97 patients took a 500-mg dose, 96 patients took a 400-mg dose and 96 patients took a placebo. The recommended daily dose is 400 mg, so only data from the group of patients that took the 400 mg dose are shown.

    The study was designed to look at:

    1. The main study goal, or primary endpoint of the study, was to measure the number of patients who had a 35% reduction or more in the volume of their spleen. This was measured after patients took 6 cycles of INREBIC and then had follow-up scans 4 weeks later.
      • To measure the change in spleen volume, patients had an MRI or CT scan after Cycle 3 and Cycle 6.

      location of spleen

    2. Also in this clinical trial, an additional goal, or secondary endpoint, of the study was to measure the percent of people who had a 50% or greater reduction in their Total Symptom Score (TSS) after 6 cycles of taking INREBIC. The TSS tallied symptom scores for each patient and looked at the following symptoms:
      night sweats

      Night sweats

      bone or muscle pain

      Bone or muscle pain

      Itching

      Itching

      pain under ribs on left side

      Pain under ribs on left side

      abdominal discomfort

      Abdominal discomfort

      early satiety

      Early satiety

       

    In the JAKARTA trial, symptoms were measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 diary.

    The modified MFSAF v2.0 is a patient diary that looked at 6 core symptoms of MF: night sweats, itching, abdominal discomfort, early satiety, pain under ribs on left side, and bone or muscle pain. The modified MFSAF diary was filled out daily during the week prior to Day 1 of each treatment cycle, and at the end of Cycle 6. Symptom scores ranged from 0 (“absent”) to 10 (“worst imaginable”). These scores were added to create the Total Symptom Score (TSS).

    What did the INREBIC study show?

    Reduced spleen volume

    In the JAKARTA study, 37% of patients had greater than or equal to 35% reduction in spleen volume after taking INREBIC for 6 cycles, with a follow-up scan 4 weeks later.

    spleen volume reduction chart

    *Out of the 289 patients, 97 patients received 500-mg dose, 96 patients 400-mg dose, 
and 96 patients a placebo. The recommended daily dose is 400 mg. That is why the 
500-mg dose arm of the study is not shown in the chart.


     

    MF symptoms studied

    INREBIC showed reduction in MF symptoms as measured by the Total Symptom Score (TSS) calculation at the end of Cycle 6.

    Reduction in TSS chart

     

    *A total of 89 patients receiving INREBIC 400 mg and 81 patients receiving placebo were evaluated in the study for this endpoint.

    Some symptoms had significant reduction but that does not mean that they went away.

     

    Selected safety findings

    Most Common Side Effects (reported in > 20% of Patients Taking INREBIC)

    side effects table

     

    These are not all of the possible side effects of INREBIC.

    Learn about side effects

     


     

    INREBIC may cause serious side effects, such as: Encephalopathy (including Wernicke’s encephalopathy). A serious and sometimes fatal neurological problem called encephalopathy (including Wernicke’s encephalopathy) has happened in some people who take INREBIC. Wernicke’s encephalopathy is a neurologic emergency that can happen if you do not have enough vitamin B1 (thiamine) in your body. Your healthcare provider will do a blood test to check your vitamin B1 level before starting and during treatment with INREBIC. Your healthcare provider may tell you to stop taking INREBIC and take a vitamin.

    Please see Important Safety Information, Prescribing Information and Medication Guide for further details.

    See how to take INREBIC.

    Learn More

    Indication

    What is INREBIC® (fedratinib)?

    INREBIC is a prescription medicine used to treat adults with certain types of myelofibrosis (MF). It is not known if INREBIC is safe and effective in children.


    Important Safety Information

    WARNING: ENCEPHALOPATHY INCLUDING WERNICKE’S

    What is the most important information I should know about INREBIC?
    INREBIC may cause serious side effects, including:

    • Encephalopathy (including Wernicke’s encephalopathy). A serious and sometimes fatal neurological problem called encephalopathy (including Wernicke’s encephalopathy) has happened in some people who take INREBIC.

       

      Wernicke’s encephalopathy is a neurologic emergency that can happen if you do not have enough vitamin B1 (thiamine) in your body. Your healthcare provider will do a blood test to check your vitamin B1 level before starting and during treatment with INREBIC. Your healthcare provider may tell you to stop taking INREBIC and take a vitamin B1 supplement if you develop side effects during treatment with INREBIC.

       

      Call your healthcare provider right away if you develop diarrhea, nausea, or vomiting that does not respond to treatment.

       

      Get emergency medical help right away if you develop the following:

      • confusion, memory problems, or drowsiness
      • problems with balance and movement, such as difficulty walking
      • eye problems, such as double or blurred vision or abnormal eye movements

       

      Call your healthcare provider if you experience rapid weight loss or weight loss that does not get better with treatment.

       

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

    • have low red blood cell or platelet counts
    • have or have had liver problems
    • have or have had kidney problems
    • are breastfeeding or plan to breastfeed. It is not known if INREBIC passes into your breast milk. You should not breastfeed during treatment with INREBIC and for at least 1 month after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with INREBIC.

     

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

     

    INREBIC and other medicines may affect each other causing unwanted side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

     

    How should I take INREBIC?

     

    What are the possible side effects of INREBIC?
    INREBIC can cause serious side effects, including:

     

    The most common side effects of INREBIC include:

     

    These are not all of the possible side effects of INREBIC.

     

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

     

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