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Who should take INREBIC?
INREBIC is a prescription medicine used to treat adults with:
Watch how INREBIC can help you take command of your MF journey.
How was INREBIC clinically studied?
Theof INREBIC was called JAKARTA. The JAKARTA study looked at whether INREBIC was safe and effective in treating adult patients with intermediate-2 or high-risk primary or secondary MF with .
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.
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:
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).
Not an actual patient.
INREBIC study results
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.
*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.
*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)
These are not all of the possible side effects of INREBIC.
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.Learn about side effects
Fedratinib (INREBIC) is recommended by the National Comprehensive Cancer Network® (NCCN®) as an initial treatment option for patients with intermediate-2 or high-risk MF who have platelet counts ≥50 × 109/L.*†1
*NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
†Patients who are not transplant candidates.
REFERENCE: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms V.2.2022. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed December 20, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.