Inrebic®

Drug - Inrebic® (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

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

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