Myelofibrosis Treatments

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Brand Name

Inrebic

Generic Name

Fedratinib

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FDA approval date: August 16, 2019

Form: Capsule

What is Inrebic (Fedratinib)?

INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis . INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis .

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Related Clinical Trials

A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated/Blast Phase Myeloproliferative Neoplasms

Who is this study for: Adult patients with Myelofibrosis

Enrollment Status: Recruiting

Publish Date: March 16, 2026

Intervention Type: Drug, Other, Procedure

Study Drugs: Decitabine, Ruxolitinib, Fedratinib

Study Phase: Phase 2

Summary: This phase II trial studies how well decitabine with ruxolitinib, fedratinib, or pacritinib works before hematopoietic stem cell transplant in treating patients with accelerated/blast phase myeloproliferative neoplasms (tumors). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or b...

Pilot Study of JAK Inhibitor Therapy Followed by Reduced Intensity Haploidentical Transplantation for Patients With Myelofibrosis

Who is this study for: Patients with myelofibrosis

Enrollment Status: Recruiting

Publish Date: January 12, 2026

Intervention Type: Radiation, Drug, Biological, Procedure

Study Drugs: Cyclophosphamide, JAK Inhibitor, Fludarabine, Recombinant Granulocyte Colony-Stimulating Factor, Melphalan, Mycophenolate Mofetil, Tacrolimus

Study Phase: Phase 2

Summary: This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo HCT in patients with MF is graft failure. In the first cohort, all patients engrafted. There were no instances of graft failure. However, a large numbe...

Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis

Enrollment Status: Recruiting

Publish Date: November 06, 2024

Intervention Type: Drug

Summary: The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF...

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Related Latest Advances

Managing myelofibrosis in the frailty era: the expanding role of JAK inhibitors.

Journal: Leukemia & lymphoma

Published: April 15, 2026

Management of splenomegaly in patients with myelofibrosis in the era of JAK inhibitors: a comprehensive review.

Journal: Frontiers in oncology

Published: April 09, 2026

SOX10 Overexpression Enhances the Oligodendrocyte Lineage Commitment of iOPCs In Vitro by Reshaping Their Chromatin Binding Landscape.

Journal: Bioengineering (Basel, Switzerland)

Published: March 16, 2026

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Brand Information

Inrebic (Fedratinib Hydrochloride)

WARNING: 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

1INDICATIONS AND USAGE

INREBIC

2DOSAGE FORMS AND STRENGTHS

Capsules: 100 mg, reddish brown, opaque size 0, printed with "FEDR 100 mg" in white ink.

3CONTRAINDICATIONS

None

4ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

Encephalopathy, including Wernicke's
Anemia and Thrombocytopenia
Gastrointestinal Toxicity
Hepatic Toxicity
Amylase and Lipase Elevation
Uveitis
Major Adverse Cardiac Events
Thrombosis
Secondary Malignancies
Symptom Exacerbation Following Interruption or Discontinuation of Treatment

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in the WARNINGS AND PRECAUTIONS Section 5.1 Encephalopathy, including Wernicke's, reflect exposure to INREBIC as a single agent in 608 patients who received more than one dose (ranging from 30 mg to 800 mg) in Studies JAKARTA, ARD11936, JAKARTA2, ARD12042, ARD12888, TED12037/TED12015, INT12497, and TES13519, of whom 459 were patients with myelofibrosis, including 97 patients previously treated with ruxolitinib. Among the 608 patients receiving INREBIC, the median drug exposure was 37 weeks and the median number of cycles initiated was 9 cycles. Fifty-nine percent of 608 patients were exposed for 6 months or longer and 39% were exposed for 12 months or longer.

Using the dataset described above, the most common adverse reactions in >20% of patients (N=608) were diarrhea, nausea, anemia, vomiting, fatigue, thrombocytopenia, and constipation.

4.2Postmarketing Experience

The following adverse reactions have been identified during post approval use of INREBIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye Disorders: Uveitis

5OVERDOSAGE

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

6DESCRIPTION

INREBIC (fedratinib) is a kinase inhibitor with the chemical name N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino]benzenesulfonamide dihydrochloride monohydrate. Its empirical formula is C

INREBIC (fedratinib) is available as 100-mg (equivalent to 117.3 mg of fedratinib dihydrochloride monohydrate) hard gelatin capsules for oral administration. Each capsule contains inactive ingredients of silicified microcrystalline cellulose and sodium stearyl fumarate. The capsule shell contains gelatin, red iron oxide, titanium dioxide and white ink.

7PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Discuss the following with patients prior to and during treatment with INREBIC.

8PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Label

NDC 59572-720-12

INREBIC

100 mg

Dispense the accompanying Medication Guide to each patient.

Rx only