INDICATIONS AND USAGE

INREBIC® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).

DOSAGE

Recommended Dosage

Conduct baseline testing of thiamine (Vitamin B1) levels prior to initiation of INREBIC.

The recommended dosage of INREBIC is 400 mg taken orally once daily for patients with a baseline platelet count of greater than or equal to 50 × 109/L.

INREBIC may be taken with or without food. Administration with a high fat meal may reduce the incidence of nausea and vomiting.

Modify the dose for patients using concomitant strong CYP3A4 inhibitors, and in patients with severe renal impairment (creatinine clearance (CLcr) 15 mL/min to 29 mL/min).

If a dose of INREBIC is missed, the next scheduled dose should be taken the following day.

Patients that are on treatment with ruxolitinib before the initiation of INREBIC must taper and discontinue according to the ruxolitinib prescribing information.

ADVERSE REACTIONS

Encephalopathy, including Wernicke's

Anemia and Thrombocytopenia

Gastrointestinal Toxicity

Hepatic Toxicity

Amylase and Lipase Elevation

Major Adverse Cardiac Events

Thrombosis

Secondary Malignancies

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f0f55a2a-4e0c-4cba-8571-03e1424486d7/spl-doc?hl=Fedratinib

Inrebicinformation