Product image of Inrebic (Fedratinib) supplied by GNH India

Inrebic

Active Ingredient:
Fedratinib
Origin:
EU

Inrebic (Fedratinib)

Fedratinib, the active ingredient in Inrebic, is a Janus kinase (JAK) inhibitor presented as a tablet for oral use. It is indicated for the treatment of primary or secondary myelofibrosis in adult patients, addressing disease‑related splenomegaly and symptom burden.

GNH India supplies Inrebic as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, providing consistent quality and regulatory compliance for global oncology programs, and supporting clinical research initiatives through reliable supply chain management.

Manufacturer / TM Owner

Bristol-Myers Squibb Pharma Eeig

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Indications & Clinical Uses

Fedratinib is a Janus kinase (JAK) inhibitor used in the management of myelofibrosis.

  • Primary myelofibrosis: reduces spleen size and improves disease‑related symptoms.
  • Secondary myelofibrosis (post‑polycythemia vera or post‑essential thrombocythemia): provides disease control comparable to primary disease.
  • Myelofibrosis with splenomegaly: decreases spleen volume and alleviates associated discomfort.

How It Works

  • Fedratinib selectively inhibits Janus kinase 2 (JAK2), a key enzyme in the JAK‑STAT signaling pathway that drives proliferation of malignant hematopoietic cells in myelofibrosis. By blocking JAK2 activity, the drug reduces downstream STAT phosphorylation, decreasing cytokine‑mediated signaling, cell proliferation, and abnormal marrow fibrosis, thereby alleviating disease manifestations. It also modulates inflammatory cytokine production, contributing to symptom relief. The selective nature of the inhibition helps limit off‑target effects compared with broader JAK inhibitors.

Side Effects

Fedratinib may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Diarrhea: watery stools that may require hydration.
  • Fatigue: persistent tiredness affecting daily activities.
  • Anemia: reduced red blood cell count leading to weakness.
  • Thrombocytopenia: lowered platelet levels increasing bleeding tendency.

Serious or Rare Side Effects

  • Wernicke encephalopathy: neurological disorder linked to thiamine deficiency.
  • Severe infections: opportunistic bacterial, fungal, or viral infections.
  • Hepatic toxicity: elevated liver enzymes or liver injury.
  • Cardiac events: arrhythmias or heart failure in susceptible patients.

Precautions & Warnings

When prescribing Fedratinib, clinicians should consider several safety measures.

  • Dose adjustment: required in hepatic impairment to avoid excess exposure.
  • Monitor blood counts: watch for anemia, thrombocytopenia, and neutropenia.
  • Infection risk: assess for active infections and treat promptly.
  • Avoid strong CYP3A4 inhibitors: concomitant use may increase fedratinib levels.
  • Pregnancy and lactation: safety not established; use only if benefit outweighs risk.
  • Store at ambient temperature: keep below 25°C, protect from moisture and light.

Avoid Interactions

Fedratinib interacts with several medicines; awareness of interaction severity guides management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may markedly increase fedratinib exposure.
  • Concomitant use with other JAK inhibitors: risk of additive myelosuppression.
  • Potent CYP3A4 inducers (e.g., rifampin): may substantially reduce efficacy.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, clarithromycin): may modestly raise plasma levels.
  • Anticoagulants (e.g., warfarin): monitor INR and bleeding risk.
  • Antiplatelet agents (e.g., aspirin, clopidogrel): observe for enhanced bleeding tendencies.

Frequently Asked Questions

Inrebic contains the active ingredient fedratinib and is approved for the treatment of primary or secondary myelofibrosis in adult patients. It helps reduce spleen enlargement and alleviates disease‑related symptoms by targeting the underlying JAK‑STAT signaling abnormalities.

Fedratinib works by selectively inhibiting the JAK2 enzyme, a central component of the JAK‑STAT pathway that drives abnormal blood cell production in myelofibrosis. Blocking JAK2 reduces downstream signaling, leading to decreased proliferation of malignant hematopoietic cells, reduced cytokine production, and improvement of marrow fibrosis.

The dosing regimen for Inrebic is determined by the prescribing healthcare professional based on the individual patient's clinical condition, liver function, and concomitant medications. Physicians tailor the dose to achieve optimal therapeutic benefit while monitoring safety parameters.

Safety data for fedratinib in pregnancy and lactation are limited. The product should be used only if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women of child‑bearing potential should discuss contraception and risk with their physician.

To request Inrebic, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including any cold‑chain requirements), and import documentation.

Inrebic (fedratinib) and ruxolitinib are both JAK inhibitors approved for myelofibrosis. Fedratinib is a more selective JAK2 inhibitor, which may offer efficacy in patients who have progressed on or are intolerant to ruxolitinib. Safety profiles differ; for example, fedratinib carries a specific risk of Wernicke encephalopathy, whereas ruxolitinib is associated with different hematologic toxicities.

Inrebic tablets should be stored at ambient temperature, below 25 °C, in their original packaging. Protect the product from moisture, excessive heat, and direct sunlight. Keep out of reach of children and do not use after the expiry date indicated on the label.

Inrebic is taken orally as a whole tablet with water. Patients should swallow the tablet whole and not crush, split, or chew it unless specifically instructed by a healthcare professional. The medication is usually taken once daily, but exact timing is determined by the prescriber.

The most serious adverse events linked to fedratinib include Wernicke encephalopathy (a neurological disorder related to thiamine deficiency), severe or opportunistic infections, significant hepatic toxicity, and profound myelosuppression such as severe anemia or thrombocytopenia. Prompt medical attention is required if any of these occur.

Inrebic should be avoided in patients with known hypersensitivity to fedratinib or any tablet excipients, those with severe hepatic impairment, active uncontrolled infections, or a history of Wernicke encephalopathy. Caution is also advised for patients on strong CYP3A4 inhibitors or inducers, and for pregnant or breastfeeding women unless the benefit justifies the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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