For polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea (HU)1
Dose optimization is key to maintaining the balance between safety and efficacy.
A complete blood count (CBC) and platelet (PLT) count must be performed before initiating therapy.1
Jakafi is also available in tablets of
A CBC and PLT count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.1
…of patients treated with Jakafi in the RESPONSE* trial had dose adjustments from the recommended starting dose by week 322
…of patients randomized to Jakafi discontinued treatment due to an adverse event1,3
Dosing in patients with renal or hepatic impairment, or when coadministered with strong CYP3A4 inhibitors or fluconazole1
DOSE MODIFICATIONS FOR SPECIAL POPULATIONS
For further information and to download the Jakafi dosing guide, click here.
Dosing of Jakafi® (ruxolitinib) in Patients With Polycythemia Vera Who Have Had an Inadequate Response to or Are Intolerant of Hydroxyurea
Hematology specialist Dr Harry Erba discusses the appropriate dosing of Jakafi® (ruxolitinib) in patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Dr Erba addresses the recommended starting dose, dose reductions based on hemoglobin levels and/or platelet counts, and dose modifications because of insufficient response in PV.
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*The RESPONSE (Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care) trial was a randomized, open-label, active-controlled phase 3 trial comparing Jakafi with best available therapy (BAT) in 222 patients with polycythemia vera. BAT included hydroxyurea (60%), interferon/pegylated interferon (12%), anagrelide (7%), pipobroman (2%), lenalidomide/thalidomide (5%), and observation (15%). Patients enrolled in the study had been diagnosed with polycythemia vera for at least 24 weeks, had an inadequate response to or were intolerant of hydroxyurea, required phlebotomy for hematocrit (Hct) control, and exhibited splenomegaly. All patients were required to demonstrate Hct control between 40% and 45% prior to randomization. After week 32, patients were able to cross over to Jakafi treatment. The composite primary endpoint was defined as Hct control without phlebotomy eligibility and a ≥35% spleen volume reduction as measured by CT or MRI. To achieve the Hct control endpoint, patients could not become eligible for phlebotomy between weeks 8 and 32. Phlebotomy eligibility was defined as Hct >45% that is ≥3 percentage points higher than baseline or Hct >48% (lower value). 23% of patients receiving Jakafi achieved the composite primary endpoint at week 32 vs <1% for BAT (P <0.0001).1,3
References
Reference
Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
Doses may be increased in 5 mg twice daily increments to a maximum of 25 mg twice daily
Use the most severe category of patients’ Hb, PLT count, or ANC abnormality to determine the corresponding maximum restarting dose:
aContinue treatment for at least 2 weeks; if stable, may increase dose by 5 mg twice daily.
Patients who required dose interruption while receiving a dose of 5 mg twice daily may restart at a dose of 5 mg twice daily or 5 mg once daily, but not higher, once:
Modify the dose of Jakafi accordingly in patients with moderate or severe renal impairment, patients with hepatic impairment, and patients on dialysis.
CrCl, creatinine clearance; PV, polycythemia vera.
Indications and Usage
Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is indicated for treatment of intermediate or high‐risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF in adults.
Jakafi is indicated for treatment of steroid‐refractory acute graft‐versus‐host disease (GVHD) in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.
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