For US Healthcare Professionals Only
For US Healthcare Professionals Only
For adults with intermediate- or high-risk MF, the recommended starting doses are based on platelet counts1
A CBC, including platelet count, must be performed before initiating Jakafi® (ruxolitinib)1
Jakafi is also available in 10-mg and 25-mg tablets.
Special populations: Please refer to the Full Prescribing Information for starting dose and other dose modifications, and for when to avoid treatment in patients with renal or hepatic impairment and in those receiving concomitant strong CYP3A4 inhibitors or fluconazole.
Monitoring patients after initiation of Jakafi is essential, especially during the first 12 weeks of therapy1
Individualize dosing of Jakafi to optimize the balance between safety and efficacy1
Managing anemia and thrombocytopenia
ANC=absolute neutrophil count; CBC=complete blood count; COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin; MF=myelofibrosis.
In COMFORT-I, 46% of patients receiving Jakafi had anemia at baseline; among these patients, mean Hb was 9.2 g/dL (range, 6.6 g/dL to 13.7 g/dL)4
Efficacy based on titrated dose
This material is under a CC BY-NC License and is the property of the Ferrata Storti Foundation. © 2023 Ferrata Storti Foundation. All rights reserved.
COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment.
Dose modifications of Jakafi and/or blood transfusions may be required for patients developing anemia1
From The New England Journal of Medicine, Verstovsek S, Mesa RA, Gotlib J, et al, A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis, 2012;366(9):799-807. Supplementary appendix available at: doi:10.1056/NEJMoa1110557. Copyright © 2012 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
This material is under a CC BY-NC License and is the property of the Ferrata Storti Foundation. © 2023 Ferrata Storti Foundation. All rights reserved.
ANC=absolute neutrophil count; CBC=complete blood count; COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin; RBC=red blood cell; SEM=standard error of the mean.
In patients with cytopenias, consider dose reductions, temporarily withholding Jakafi, or transfusions as clinically indicated.1
Monitor CBCs during treatment, beginning as early as weeks 2 to 4.1
aProtocol-mandated dose modifications occurred based on platelet count.
CBC=complete blood count; COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin; LLN=lower limit of normal.
In the case of a hematologic toxicity, including:
Thrombocytopenia
Discontinuations can be avoided by reducing the dose or temporarily withholding Jakafi.
Anemia
Dose modifications of Jakafi and/or blood transfusions may be required for patients developing anemia.1
COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin.
Decreasing dose for hematologic toxicity
Reduce the dose of Jakafi in patients with platelet counts <35 × 109/L.
Interrupt treatment for bleeding requiring intervention regardless of current platelet count. Once the bleeding event has resolved, consider resuming treatment at the prior dose if the underlying cause of bleeding has been controlled. If the bleeding event has resolved but the underlying cause persists, consider resuming treatment with Jakafi at a lower dose.
Dose modifications in patients with renal or hepatic impairment, or when coadministered with strong CYP3A4 inhibitors or fluconazole
Patients with ESRD on dialysis
Concomitant use with strong CYP3A4 inhibitors or fluconazole
BID=twice daily; CLcr=creatinine clearance; ESRD=end-stage renal disease; MPN=myeloproliferative neoplasm; OS=overall survival; SVR=spleen volume reduction.
References: 1. Jakafi [package insert]. Wilmington, DE: Incyte Corporation. 2. Verstovsek S, Mesa RA, Gotlib J, et al. Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica. 2013;98(12):1865-1871. Supplementary appendix available at: https://haematologica.org/article/view/6861. 3. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807. Supplementary appendix available at: https://www.nejm.org/doi/full/10.1056/nejmoa1110557. 4. 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.