For US Healthcare Professionals Only
For US Healthcare Professionals Only
For PV in adults who have had an inadequate response to HU1
For patients with PV who have an inadequate response to HU, the recommended starting dose is 10 mg BID.
A CBC and platelet count must be performed before initiating Jakafi.
Jakafi is also available in tablets of:
A CBC and platelet count must be performed before initiating Jakafi, every 2 to 4 weeks until doses are stabilized, and then as clinically indicated.
of patients treated with Jakafi in the RESPONSE trial had dose adjustments from the recommended starting dose by week 322
Individualize dosing of Jakafi to optimize the balance between safety and efficacy.
BID=twice daily; CBC=complete blood count; Hb=hemoglobin; HU=hydroxyurea; PV=polycythemia vera; RESPONSE=Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care.
Among those taking Jakafi in the RESPONSE trial, 5% (6/110) of patients decreased from the starting dose at week 8, and 13% (14/110) of patients decreased from the starting dose at week 32.2
BID=twice daily; Hb=hemoglobin; RESPONSE=Randomized study of Efficacy and Safety in Polycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care.
Doses may be increased in increments of 5 mg BID to a maximum of 25 mg BID
Among those taking Jakafi in the RESPONSE trial, 37% (41/110) of patients increased from the starting dose at week 8, and 54% (59/110) of patients increased from the starting dose at week 32.2
of patients randomized to Jakafi discontinued treatment due to an adverse event1
ANC=absolute neutrophil count; BID=twice daily; Hb=hemoglobin; RESPONSE=Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care; ULN=upper limit of normal; WBC=white blood cell.
Interrupt Jakafi treatment for:
After recovery of hematologic parameter(s) to acceptable levels, dosing may be restarted
Use the most severe category of patients’ Hb, platelet count, or ANC abnormality to determine the corresponding maximum restarting dose:
Patients who required dose interruption while receiving a dose of 5 mg BID may restart at a dose of 5 mg BID or 5 mg once daily, but not higher, when they have:
Dose management after restarting treatment in PV
Special populations:
ANC=absolute neutrophil count; BID=twice daily; CLcr=creatinine clearance; Hb=hemoglobin; PV=polycythemia vera.
Modify the dose of Jakafi accordingly in patients with moderate or severe renal impairment, patients with hepatic impairment, and patients on dialysis.
Patients with end-stage renal disease on dialysis
Concomitant use with strong CYP3A4 inhibitors or fluconazole
BID=twice daily; CLcr=creatinine clearance; PV=polycythemia vera.
HU=hydroxyurea; MPN=myeloproliferative neoplasm; PV=polycythemia vera.
References: 1. Jakafi [package insert]. Wilmington, DE: Incyte Corporation. 2. Data on file. Incyte Corporation. Wilmington, DE.
Indications and Usage
Jakafi® (ruxolitinib) 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 (aGVHD) in adult and pediatric patients 12 years and older.
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.
Indications and Usage
Jakafi® (ruxolitinib) 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 (aGVHD) in adult and pediatric patients 12 years and older.
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.