Inrebic

Fedratinib

• Brand(s): Inrebic
• Dosage Form/Strength: 100 mg capsule
• Effective date: September 8, 2022

Initiation criteria:

For the treatment of splenomegaly and/or disease related symptoms of myelofibrosis in patients meeting the following criteria:

1. Patient is 18 years of age or older; AND

2. Has been diagnosed with one of the following conditions which have resulted in the splenomegaly and/or other constitutional symptoms

   a) intermediate-2 or high-risk primary myelofibrosis

   b) post-polycythemia vera myelofibrosis

   c) post-essential thrombocythemia myelofibrosis.
   
   AND

3. Has a contraindication to ruxolitnib or has developed intolerances to ruxolitinib but has not experienced disease progression while on ruxolitinib; AND

4. Has a good performance status; AND

5. Patient is using fedratinib under the care of a clinician who is experienced in the treatment of myelofibrosis.

Notes:

1. The details of contraindications and intolerances are to be included with the application

2. Patients should have documented improvement of spleen size or constitutional symptoms within 6 months of start of fedratinib.

3. Patients should be monitored every 3 to 6 months.

4. Treatment with fedratinib should be discontinued in patients who demonstrate progressive increase in spleen size, return of constitutional symptoms, development of serious adverse events

Exclusion criteria:

• Fedratinib will not be funded in patients who have experienced disease progression while on ruxolitinib.
• Fedratinib will not be funded in combination with another Janus kinase (JAK) inhibitor or other therapies used to treat MF

Approved dose: Up to 400 mg daily

Renewal Criteria:
Renewal of funding will continue in patients who have demonstrated response to treatment until any one of the following are demonstrated; progressive increase in spleen size, return of constitutional symptoms, or development of serious adverse events.

Approval duration of initials: 7 months

Approval duration of renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests