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Home > Drugs > Drugs > Fedratinib (systemic) (monograph) > Fedratinib Dosage
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https://themeditary.com/dosage-information/fedratinib-dosage-15680.html

Fedratinib Dosage

Drug Detail:Fedratinib (systemic) (monograph) (Inrebic)

Drug Class:

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Usual Adult Dose for Myelofibrosis

For patients with a baseline platelet count of 50 x 10(9)/L or greater:
400 mg orally once a day

Comments:

  • Patients who are taking ruxolitinib: Patients should taper off and discontinue ruxolitinib prior to starting this drug.
  • Assess thiamine (vitamin B1) levels and nutritional status prior to starting therapy, periodically during therapy, and as indicated.
  • Administration with a high fat meal may reduce the incidence of nausea and vomiting.
  • Subsequent doses of this drug are subject to dose adjustments based on the concomitant use of CYP450 3A4 inhibitors, renal function, prior adverse reactions, and/or thiamine levels.

Use: For the treatment of patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF)

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 to 89 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl 15 to 29 mL/min): Reduce the dose to 200 mg/day.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction (total bilirubin greater than 3 times the upper limit of normal [3 x ULN] and any AST): Not recommended.

Baseline liver function test levels should be obtained before starting treatment; levels should be obtained periodically and when clinically indicated throughout treatment.

Dose Adjustments

DISCONTINUATION OF TREATMENT:

  • Treatment should be discontinued in patients unable to tolerate 200 mg/day.

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:
  • Consider dose reductions in patients who become transfusion-dependent during therapy with this drug.
  • 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/day below the last given dose.
  • Grade 4 Neutropenia: Withhold therapy until resolved to Grade 2 or less or baseline, restart dose at 100 mg/day 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/day 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/day below the last given dose; monitor ALT, AST, and bilirubin (total and direct) more frequently following the dose reduction.
  • Discontinue therapy if a Grade 3 or higher elevation recurs
  • Grade 3 or Higher Other Nonhematologic Toxicities: Withhold therapy until resolved to Grade 1 or less or baseline; restart dose at 100 mg/day below the last given dose.

MANAGEMENT OF THIAMINE LEVELS AND WERNICKE'S ENCEPHALOPATHY (WE):
  • Assess thiamine (vitamin B1) 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 WE is suspected, immediately discontinue therapy and initiate parenteral thiamine treatment.
  • Monitor until symptoms resolve or improve and thiamine levels normalize.

Precautions

US BOXED WARNINGS:
ENCEPHALOPATHY INCLUDING WERNICKE'S:

  • Serious and fatal encephalopathy, including Wernicke's, occurred in patients treated with this drug.
  • Wernicke's encephalopathy is a neurologic emergency.
Recommendations:
  • Thiamine levels should be assessed in all patients prior to starting treatment, and then should be assessed periodically during treatment, as clinically indicated.
  • This drug should not be started in patients with thiamine deficiency; thiamine should be repleted prior to initiating treatment.
  • Treatment should be immediately discontinued and parenteral thiamine initiated if encephalopathy is suspected.
  • Patients should be monitored until symptoms resolve and/or thiamine levels resolve.

CONTRAINDICATIONS:
  • None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • This drug may be taken with or without food.
  • If a dose 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.

Storage requirements:
  • Store below 86F (30C).

Monitoring:
Levels of the following should be obtained prior to initiation, periodically during therapy, and as indicated:
  • GASTROINTESTINAL: Amylase and lipase levels
  • GENITOURINARY: Creatinine
  • HEMATOLOGIC: Complete blood count with platelets
  • HEPATIC: Liver function tests
  • METABOLIC: Thiamine (Vitamin B1) levels
  • RENAL: BUN

Patient advice:
  • Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
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