Medically reviewed by Drugs.com. Last updated on Oct 11, 2019.
Applies to the following strengths: 100 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Myelofibrosis
For patients with a baseline platelet count of 50 x 109/L or greater:
400 mg orally once a day
Management of thiamine levels and Wernicke's encephalopathy (WE):
-Assess thiamine levels and nutritional status prior to starting therapy, periodically during therapy, and as indicated.
-Do not initiate this drug in patients with thiamine deficiency; replete thiamine prior to therapy initiation and during therapy if thiamine levels are low.
-If Wernicke's encephalopathy is suspected, immediately discontinue therapy and initiate parenteral thiamine treatment.
-Monitor until symptoms resolve or improve and thiamine levels normalize.
Use: For the treatment of intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)
Renal Dose Adjustments
Mild to moderate renal impairment: No adjustment recommended.
Severe renal impairment (CrCl 15 to 29 mL/min): Reduce the dose to 200 mg orally once a day.
Liver Dose Adjustments
Mild to moderate hepatic impairment: No adjustment recommended.
Severe hepatic impairment (total bilirubin greater than 3 x ULN and any AST): Not recommended.
Discontinue therapy in patients unable to tolerate 200 mg daily.
Consider dose reductions in patients who become transfusion-dependent during therapy with this drug.
DOSE MODIFICATIONS WITH CONCOMITANT USE OF STRONG CYP450 3A4 INHIBITORS:
-Reduce the dose of this drug when administering with strong CYP450 3A4 inhibitors to 200 mg orally once a day.
-If the strong CYP450 3A4 inhibitor is discontinued, increase the dose of this drug to 300 mg orally once d day during the first 2 weeks after discontinuation of the CYP450 3A4 inhibitor, and then to 400 mg orally once a day thereafter as tolerated.
DOSE MODIFICATIONS FOR HEMATOLOGIC ADVERSE REACTIONS:
-Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with active bleeding: Withhold therapy until resolved to Grade 2 or less or baseline; restart at 100 mg daily below the last given dose.
-Grade 4 Neutropenia: Withhold therapy until resolved to Grade 2 or less or baseline, restart dose at 100 mg daily below the last given dose.
`DOSE MODIFICATIONS FOR NONHEMATOLOGIC ADVERSE REACTIONS:
-Grade 3 or higher nausea, vomiting, or diarrhea not responding to supportive measures within 48 hours: Withhold therapy until resolved to Grade 1 or less or baseline; restart dose at 100 mg daily below the last given dose.
-Grade 3 or higher ALT, AST, or bilirubin: Withhold therapy until resolved to Grade 1 or less or baseline; restart dose at 100 mg daily below the last given dose; monitor ALT, AST, and bilirubin (total and direct) more frequently following the dose reduction; if reoccurrence of a Grade 3 or higher elevation, discontinue therapy.
-Grade 3 or higher other nonhematologic toxicities: Withhold therapy until resolved to Grade 1 or less or baseline; restart dose at 100 mg daily below the last given dose.
US BOXED WARNINGS:
-Serious and fatal encephalopathy, including Wernicke's, has occurred.
-Wernicke's encephalopathy is a neurologic emergency.
-Assess thiamine levels in all patients prior to initiating this drug, periodically during therapy, and as clinically indicated.
-Do not initiate this drug in patients with thiamine deficiency; replete thiamine prior to initiation.
-If encephalopathy is suspected, immediately discontinue this drug and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-This drug may be taken with or without food.
-Administration with a high fat meal may reduce the incidence of nausea and vomiting.
-If a dose of is missed, the next scheduled dose should be taken the following day.
-Patients taking ruxolitinib before initiation of this drug should taper and discontinue according to the ruxolitinib prescribing information.
-Store below 86F (30C).
-Obtain thiamine (Vitamin B1) levels, complete blood count with platelets, creatinine and BUN, hepatic panel, amylase levels, and lipase levels prior to initiation of therapy, periodically during therapy, and as indicated.
More about fedratinib
- Side Effects
- During Pregnancy
- Drug Interactions
- En Español
- 1 Review
- Drug class: multikinase inhibitors
- Other brands
Related treatment guides
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.