Prescription medicine
Fedratinib Brand names: Inrebic
Fedratinib (Inrebic) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the fedratinib FDA label on DailyMed (effective July 20, 2026, Celgene Corporation); the NDA 212327 record on Drugs@FDA; every fedratinib label on DailyMed.
Highlights of the record
FDA label of July 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ENCEPHALOPATHY INCLUDING WERNICKE'S.
Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize [see Dosage and Administration (2.6), Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. WARNING: ENCEPHALOPATHY INCLUDING WERNICKE'S See full prescribing information for complete boxed warning. Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. […]
Used for
From the label: indications and usageINREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
Forms and strengths
- 100 mg
Capsule.
On the market
- Earliest approval on file
- August 16, 2019 Inrebic, Bristol-Myers; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 24, 2039 Inrebic capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,322 through July 30, 2026
What is fedratinib used for?
From the label: indications and usageINREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ).
Source: FDA drug label (Inrebic), NDA212327 (Bristol-Myers), as published by Celgene Corporation, effective July 20, 2026 (SPL set f0f55a2a-4e0c-4cba-8571-03e1424486d7), via openFDA; the full label on DailyMed
What does the patient leaflet for fedratinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: 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 and treat you with Vitamin B1 if your level is too low before starting treatment with INREBIC. Your healthcare provider may also check your Vitamin B1 level during treatment with INREBIC. You should take a Vitamin B1 supplement (100 mg of thiamine) daily during treatment with INREBIC. Your healthcare provider may tell you to stop taking INREBIC if you develop side effects during treatment with INREBIC. Get emergency medical help right away if you develop the following: o confusion, memory problems or drowsiness o problems with balance and movement, such as difficulty walking o eye problems, such as double or blurred vision or abnormal eye movements Call your healthcare provider right away if you experience diarrhea, nausea, vomiting, and weight loss that does not get better with treatment. See “What are the possible side effects of INREBIC” for more information about side effects. What is INREBIC? 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. […]
From the patient leaflet: How should I store INREBIC?Store INREBIC below 86°F (30°C). Keep INREBIC and all medicines out of the reach of children.
Source: FDA drug label (Inrebic), NDA212327 (Bristol-Myers), as published by Celgene Corporation, effective July 20, 2026 (SPL set f0f55a2a-4e0c-4cba-8571-03e1424486d7), via openFDA; the full label on DailyMed
Is there a generic for fedratinib (Inrebic)?
No generic fedratinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Inrebic capsules: the compound patent runs to November 16, 2031, and the last listed entry to September 24, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the fedratinib label say about other medicines?
The fedratinib label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Metformin | drug interactions | Monitor for adverse reactions and consider dose modifications for drugs that are renally excreted via OCT2 or MATE1/2-K (e.g., metformin), as necessary when coadministered with INREBIC. |
| Thiamine | boxed warning | While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. |
Source: FDA drug label (Inrebic), NDA212327 (Bristol-Myers), as published by Celgene Corporation, effective July 20, 2026 (SPL set f0f55a2a-4e0c-4cba-8571-03e1424486d7), via openFDA; the full label on DailyMed
What do FAERS reports show for fedratinib?
The FDA Adverse Event Reporting System holds 1,322 reports that list fedratinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 189 are coded as a death and 258 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Fedratinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other