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DrugInrebic® (fedratinib) [Celgene Corporation]

February 2020

Therapeutic area - Oncology, Oral - Hematologic

Initial approval criteria

  • Patient is ≥ 18 years old AND
  • Patient has adequate thiamine (vitamin B1) levels as evidenced by baseline testing prior to initiation of therapy AND
  • Patient has had a documented baseline amylase and lipase level tested prior to initiation of therapy AND
  • Therapy will not be used with other JAK2-inhibitor type drugs (e.g.,ruxolitinib) AND
  • Therapy will not be used in combination with other systemic chemotherapy (e.g., hydroxyurea, lenalidomide, thalidomide, azacitidine, etc.) AND
  • Patient will avoid concomitant use with the following drugs:
    • Moderate and strong CYP3A4 inducers (e.g., rifampin, carbamazepine, St. John’s wort, etc.) OR
    • Patient will avoid concomitant use with dual CYP3A4 and CYP2C19 inhibitors (e.g., ketoconazole, etc.). If avoidance is not possible, Inrebic dose will be decreased AND
  • Patient has a diagnosis of myelofibrosis (MF) (including primary, post-polycythemia vera and post-essential thrombocythemia MF) AND
  • Patient has intermediate-2 or high-risk disease AND
  • Patient’s baseline platelet count (<30 days old) is ≥ 50 X 109/L AND
  • Patient has palpable splenomegaly (e.g., at least 5 cm below costal margin)
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the above initial approval criteria AND
  • Patient is absent of unacceptable toxicity from the drug including severe hematologic toxicity (thrombocytopenia and anemia), hepatotoxicity, severe nausea/vomiting/diarrhea, amylase/lipase elevations, etc. AND
  • Patient demonstrates treatment response to fedratinib (Inrebic) with a decrease in spleen size or improvements in other myelofibrosis symptoms (such as fatigue, bone pain, frequent infections, fever, night sweats, easy bruising/bleeding, etc.)
  • Renewal approval is for 12 months

Quantity limits

  • 120 capsules per 30 days


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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