INREBIC (fedratinib) 100 mg capsules: Reddish brown, opaque, size 0 capsule, printed with "FEDR 100 mg" in white ink.
Bottles of 120 capsules (NDC 59572-720-12) These highlights do not include all the information needed to use INREBIC safely and effectively. See full prescribing information for INREBIC.
INREBIC� (fedratinib) capsules, for oral use
Initial U.S. Approval: 2019
WARNING: ENCEPHALOPATHY INCLUDING WERNICKE'S
See full prescribing information for complete boxed warning.
Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize. (2.6, 5.1, 6.1).
INDICATIONS AND USAGE
INREBIC is a kinase inhibitor 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) (1).
DOSAGE AND ADMINISTRATION
Recommended Dosage: 400 mg orally once daily with or without food for patients with a baseline platelet count of greater than or equal to 50 � 109/L (2.1).
Reduce dose for patients taking strong CYP3A inhibitors or with severe renal impairment (2.3, 2.4, 7.1, 8.6).
DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg (3).
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Anemia and Thrombocytopenia: Manage by dose reduction, interruption, or transfusion (5.2).
Gastrointestinal Toxicity: Manage by dose reduction or interruption if patient develops severe diarrhea, nausea, or vomiting. Prophylaxis with anti-emetics and treatment with anti-diarrhea medications are recommended (5.3).
Hepatic Toxicity: Manage by dose reduction or interruption (5.4).
Amylase and Lipase Elevation: Manage by dose reduction or interruption (5.5).
ADVERSE REACTIONS
The most common adverse reactions (?20%) are diarrhea, nausea, anemia, and vomiting (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP3A4 Inhibitors: Reduce INREBIC dose as recommended (2.3, 7.1).
Strong and Moderate CYP3A4 Inducers: Avoid use of INREBIC (7.1).
Dual CYP3A4 and CYP2C19 Inhibitor: Avoid use of INREBIC (7.1).
USE IN SPECIFIC POPULATIONS
Lactation: Advise not to breastfeed (8.2).
Severe Hepatic Impairment: Avoid use of INREBIC (8.7).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2019
16.2 Storage
Store below 86�F (30�C).
