Fedratinib is a prescription medicine 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). It is available as capsules for oral use. MedsAcross supplies Fedratinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
INREBIC ® 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).
Source: US FDA prescribing information
Fedratinib is an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Fedratinib is a JAK2-selective inhibitor with higher inhibitory activity for JAK2 over family members JAK1, JAK3 and TYK2. Abnormal activation of JAK2 is associated with myeloproliferative neoplasms (MPNs), including myelofibrosis and polycythemia vera. In cell models expressing mutationally active JAK2 V617F or FLT3 ITD, fedratinib reduced phosphorylation of signal transducer and activator of transcription (STAT3/5) proteins, inhibited cell proliferation, and induced apoptotic cell death. In mouse models of JAK2 V617F -driven myeloproliferative disease, fedratinib blocked phosphorylation of STAT3/5, and improved survival, white blood cell counts, hematocrit, splenomegaly, and fibrosis.
Source: US FDA prescribing information
• Recommended Dosage: 400 mg orally once daily with or without food for patients with a baseline platelet count of greater than or equal to 50 × 10 9 /L. • For patients who have difficulty swallowing capsules whole or those with a nasogastric tube, the content of the capsule(s) may be dispersed in Ensure ® Plus. • Reduce dose for patients taking strong CYP3A inhibitors or with severe renal impairment.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Boxed 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. • Anemia and Thrombocytopenia: Manage by dose reduction, interruption, or transfusion. • Gastrointestinal Toxicity: Manage by dose reduction or interruption if patient develops severe diarrhea, nausea, or vomiting. Prophylaxis with antiemetics and treatment with antidiarrhea medications are recommended. • Hepatic Toxicity: Manage by dose reduction or interruption. • Amylase and Lipase Elevation: Manage by dose reduction or interruption. • Uveitis: Monitor for symptoms and refer for ophthalmological evaluation.
Source: US FDA prescribing information
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 The most common adverse reactions (≥20%) are diarrhea, nausea, anemia, and vomiting.
Source: US FDA prescribing information
• Strong CYP3A4 Inhibitors: Reduce INREBIC dose as recommended. • Strong and Moderate CYP3A4 Inducers: Avoid use of INREBIC. • CYP3A4, CYP2C19, or CYP2D6 Substrates: Dose modifications of substrates drugs may be needed. • OCT2 and MATE1/2-K Substrates: Dose modifications of substrate drugs may be needed.
Source: US FDA prescribing information
Store below 30°C (86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Fedratinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Inrebic 100 mg capsuleOral | Celgene | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Fedratinib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Fedratinib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Fedratinib, including Inrebic.
Yes. The US FDA first approved Fedratinib on 16 August 2019, according to Drugs@FDA.
Yes. Fedratinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Fedratinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Fedratinib is classified under ATC code L01EJ02 (Fedratinib).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.