Fedratinib (Inrebic)

General information

Class/mechanism from the NCI Drug Dictionary: An orally bioavailable, small-molecule, ATP-competitive inhibitor of Janus-associated kinase 2 (JAK2) with potential antineoplastic activity. Fedratinib competes with JAK2 as well as the mutated form AK2V617F for ATP binding, which may result in inhibition of JAK2 activation, inhibition of the JAK-STAT signaling pathway, and the induction of tumor cell apoptosis.
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, UpToDate Lexidrug, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Myelofibrosis

History of changes in FDA indication

• 2019-08-16: Initial approval for adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). (Based on JAKARTA)

History of changes in EMA indication

• 2021-02-08: Initial authorization as Inrebic
• Inrebic is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis who are Janus Associated Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib.

Patient Drug Information

• Fedratinib (Inrebic) Package Insert

Also known as

• Code names: SAR-302503, TG-101348
• Brand names: Inrebic