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 JAK2 inhibitor presented as a tablet for oral use. It is approved in the European Union for the treatment of primary myelofibrosis and for post‑polycythemia vera or post‑essential thrombocythemia myelofibrosis in adult patients.

GNH India supplies Inrebic as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, transplant centres and pharmacies worldwide, ensuring quality and regulatory compliance. Our distribution network reaches major treatment facilities across Europe, Asia and the Americas, providing reliable access to this targeted therapy.

Manufacturer / TM Owner

Bristol-Myers Squibb Pharma Eeig

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Indications & Clinical Uses

  • Inrebic (fedratinib) is indicated for the treatment of myeloproliferative neoplasms that involve abnormal JAK2 signaling.
  • Primary myelofibrosis: reduces spleen volume, alleviates constitutional symptoms and may improve blood counts in patients with this primary disease.
  • Post‑polycythemia vera myelofibrosis: mitigates disease progression, lessens splenomegaly and helps control anemia and other myelofibrosis‑related symptoms.
  • Post‑essential thrombocythemia myelofibrosis: helps manage splenomegaly, reduces symptom burden and supports hematologic stability in patients who have transformed from essential thrombocythemia.

How It Works

  • Fedratinib selectively inhibits Janus kinase 2 (JAK2), a central enzyme in the JAK‑STAT signaling cascade that drives proliferation of malignant hematopoietic cells. By blocking JAK2 activity, the drug prevents downstream STAT phosphorylation, decreasing transcription of genes that promote cell growth and survival, thereby limiting the expansion of clonal myeloid cells in myelofibrosis.

Side Effects

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

Common Side Effects

  • Diarrhea: loose stools that may be mild to moderate.
  • Nausea: feeling of sickness often occurring after dosing.
  • Fatigue: persistent tiredness affecting daily activities.
  • Anemia: reduced red blood cell count leading to weakness.

Serious or Rare Side Effects

  • Wernicke encephalopathy: neurological disorder associated with thiamine deficiency.
  • Severe infections: opportunistic bacterial or fungal infections requiring medical attention.
  • Hepatotoxicity: elevated liver enzymes indicating potential liver injury.

Precautions & Warnings

  • When using Inrebic, several safety measures should be observed.
  • Monitor blood counts: regular CBC testing to detect anemia or thrombocytopenia.
  • Assess liver function: periodic liver enzyme tests for hepatotoxicity.
  • Evaluate for thiamine deficiency: consider supplementation to prevent Wernicke encephalopathy.
  • Avoid use in patients with active severe infections.
  • Pregnancy and lactation: use only if potential benefit outweighs risk; data are limited.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.

Avoid Interactions

Fedratinib can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: may increase fedratinib plasma levels, raising toxicity risk.
  • Concomitant use with other JAK inhibitors: can cause additive myelosuppression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers: may reduce fedratinib efficacy.
  • Anticoagulants: increased bleeding risk due to possible thrombocytopenia.
  • Live vaccines: potential reduced efficacy; assess timing relative to therapy.

Frequently Asked Questions

Inrebic is prescribed for adult patients with primary myelofibrosis or for those whose disease has progressed from polycythemia vera or essential thrombocythemia to myelofibrosis. It targets the underlying JAK2-driven pathology to reduce spleen size, improve symptoms and help manage blood count abnormalities.

Fedratinib works by selectively inhibiting the Janus kinase 2 (JAK2) enzyme, a key component of the JAK‑STAT signaling pathway that drives the growth of malignant blood cells. Blocking JAK2 reduces downstream signaling, limiting the proliferation and survival of the abnormal hematopoietic clones responsible for myelofibrosis.

The dose of Inrebic is determined by the prescribing healthcare professional based on the patient’s clinical condition, disease severity, and laboratory parameters. The prescriber will select the appropriate strength and dosing schedule according to the product labeling and individual patient needs.

Safety data for Inrebic in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women of childbearing potential should discuss contraception and risk with their healthcare provider before starting therapy.

To order 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 the request, the sales team will verify trade or institutional credentials and respond with pricing, availability, shipping details and any required import documentation.

The primary alternative to Inrebic is ruxolitinib, a JAK1/2 inhibitor. While both target the JAK‑STAT pathway, fedratinib is more selective for JAK2 and may be preferred in patients who have progressed after ruxolitinib or who have specific JAK2‑driven disease characteristics. Efficacy and safety profiles differ, so treatment choice depends on individual patient factors.

Inrebic tablets should be stored at ambient temperature, below 25 °C, in their original packaging to protect them from moisture. Keep the container tightly closed and out of direct sunlight. Do not refrigerate or freeze the tablets, and keep them out of reach of children.

Inrebic is taken orally as a tablet with a full glass of water. It is usually taken once daily, but the exact schedule is set by the prescribing clinician. Patients should follow any specific instructions regarding food intake or timing relative to other medications as indicated in the prescribing information.

The most serious risks include Wernicke encephalopathy, which can result from thiamine deficiency, severe infections due to immunosuppression, and hepatotoxicity manifested by elevated liver enzymes. Patients should be monitored closely for neurological symptoms, signs of infection, and liver function abnormalities throughout treatment.

Inrebic should be avoided in patients with known hypersensitivity to fedratinib or any tablet excipients, in those with active severe infections, and in individuals with uncontrolled liver disease. Caution is also advised for patients with a history of thiamine deficiency or those taking strong CYP3A4 inhibitors without appropriate dose adjustments.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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