INREBIC (fedratinib)
SELF ADMINISTRATION- ORAL
Indications for Prior Authorization:
- Indicated for adults with intermediate-2 risk or high-risk primary or secondary (post-polycythemia vera (PV) or post-essential thrombocytopenia) myelofibrosis (MF).
Patients must meet the following criteria for the indication(s) above:
- Patient is 18 years of age or older, AND
- Diagnosis of intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocytopenia) myelofibrosis, AND
- Prescribed by or in consultation with an oncologist and/or physician who specializes in the management of bone cancer disorders, AND
- Documentation of baseline laboratory testing for thiamine, Vitamin B1 (Inrebic should not be started in patients with thiamine deficiency due to risk of Wernicke’s encephalopathy) AND platelet levels prior to initiation (baseline platelet count at least 50 x 109/L), AND
- Patient has tried and failed or intolerant to Jakafi, AND
- Patients receiving ruxolitinib (Jakafi) must taper and discontinue prior to initiation of Inrebic
Dosing:
- Recommended dosing is 400 mg once daily for patient with a baseline platelet count of greater than or equal to 50 x10^9/L
Approval:
- 1 year
Last review date: October 15, 2019