Inrebic Generic Name & Formulations
Fedratinib 100mg; caps.
Treatment of intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
Inrebic Dosage and Administration
Baseline platelet count ≥50X109/L: 400mg once daily. Given with a high fat meal may reduce nausea/vomiting. Concomitant strong CYP3A4 inhibitors: 200mg once daily; when CYP3A4 inhibitor discontinued: give 300mg once daily for the first 2 weeks, then 400mg once daily as tolerated. Severe renal impairment (CrCl 15–29mL/min): 200mg once daily. Dose modifications for adverse reactions: see full labeling.
Inrebic Boxed Warnings
Encephalopathy, including Wernicke’s.
Risk of serious encephalopathy, including Wernicke’s; if suspected, immediately discontinue and initiate parenteral thiamine. Monitor until symptoms resolve and thiamine levels normalize. Do not start in thiamine deficiency; replete thiamine prior to treatment initiation. Risk of anemia, thrombocytopenia. Obtain thiamine levels, CBC with platelets, creatinine, BUN, hepatic panel, amylase, lipase, and nutritional status prior to initiation, during therapy, and as clinically indicated. Consider prophylaxis with anti-emetics (eg, 5-HT3 antagonists) during therapy. Monitor for serious cardiovascular events, secondary malignancies. Evaluate and treat if thrombosis occurs. Current or past smokers. Severe or pre-existing moderate renal impairment. Severe hepatic impairment: avoid. Pregnancy. Nursing mothers: not recommended (during and for ≥1 month after the last dose).
Potentiated by strong CYP3A4 inhibitors; consider alternatives or reduce Inrebic dose (see Adult). Avoid concomitant strong or moderate CYP3A4 inducers, dual CYP3A4/CYP2C19 inhibitors. Potentiates CYP3A4, CYP2C19, or CYP2D6 substrates; monitor and adjust dose of these substrates. Decreased renal clearance of OCT2 and MATE1/2-K substrates (eg, metformin); monitor and consider dose modifications as needed.
Inrebic Adverse Reactions
Diarrhea, nausea, anemia, vomiting; GI toxicity, hepatic toxicity, amylase/lipase elevation.
Inrebic Clinical Trials
Inrebic Patient Counseling