Primary Myelofibrosis (MF) Disease | Jakafi HCP
For US Healthcare Professionals Only
Image of doctor and patient learning about advanced PV

When do you intervene in patients with intermediate- or high-risk MF?

 

MF is a serious disease that may require active management at diagnosis.1

 
Image of chart that shows Cancer 5- Year Overall Survival Rates
Image of chart that shows Cancer 5- Year Overall Survival Rates

aFive-year overall survival rates were estimated using SEER data obtained from population-based cancer registries of the US population and SEER*Stat Software version 8.3.2. The analysis included patients with initial/primary site diagnosis between years 2007-2011. Overall survival is defined as the time from diagnosis until death from any cause.

 

In MF, the presence of any of the following risk factors* indicates that a patient is already intermediate risk3,4:

  • Hemoglobin level <10 g/dL
  • Leukocyte count >25 × 109/L
  • Age >65 years
  • Red cell transfusion dependency
  • Circulating blast cells ≥1%
  • Platelet count <100 × 109/L
  • Constitutional symptoms
  • Unfavorable karyotype

*As included in the Dynamic International Prognostic Scoring System Plus tool.

Image of 3 bottles of Jakafi – Review Jakafi Dosing in Myelofibrosis

REVIEW JAKAFI DOSING
IN MYELOFIBROSIS

In a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis4

Image of graphic that reads – 90% In a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis

In a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis4

Consider one of your patients with myelofibrosis

Which risk factors† does your patient have?

As the clinical understanding of myelofibrosis has evolved, a variety of prognostic systems have been developed.3

All of the systems utilize a group of risk factors to assign risk level (low, intermediate, or high) which may be useful in counseling patients with MF and deciding on therapeutic approach.3-5

One of these systems, DIPSS Plus, is based on 8 risk factors, including karyotype, transfusion dependency, and platelet count less than 100 × 109/L.4

Select as many risk factors as apply for your patient. When done, click "Submit." To consider another patient, click "Reset."

†As included in the Dynamic International Prognostic Scoring System Plus tool.

 
SUBMIT RESET Scroll down to see results.

FOR EDUCATIONAL PURPOSES ONLY. This does not take the place of a physician’s clinical judgment. Results provide a suggested approach to diagnosis and are not a substitute for a series of clinical decisions over time for each individual patient.

Dynamic International Prognostic Scoring System Plus4

Risk Factors
Risk Stratification
Median Life Expectancy
0
Low Risk
15.4 years
1
Intermediate-1
6.5 years
2-3
Intermediate-2
2.9 years
4 or more
High Risk
1.3 years

Adapted from Gangat, J Clin Oncol. 2011;29:392-397.4

Actively manage your patients by intervening at diagnosis.

…of patients with primary MF may be appropriate for treatment with Jakafi‡

Image of graphic that reads – 90% In a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis

…of patients with primary MF may be appropriate for treatment with Jakafi‡

‡Based on a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis.4

 

New or increasing splenomegaly is considered to be a marker of disease progression in myelofibrosis.6

A palpable spleen of ≥5 cm below the left costal margin constitutes progressive disease,§ according to the IWG-MRT and ELN response criteria.6

In a study of 1,054 patients with primary myelofibrosis, approximately 90% of patients for whom data were available had palpable splenomegaly at diagnosis3||

Image of graphic that reads – 90% In a study of patients with primary MF, approximately 90% (375/428) of evaluable patients were considered to be intermediate or high risk within 1 year of diagnosis

In a study of 1,054 patients with primary myelofibrosis, approximately 90% of patients for whom data were available had palpable splenomegaly at diagnosis3||

Imaging, including ultrasound, may be appropriate for patients with a body habitus which precludes palpation.8

ELN, European LeukemiaNet; IWG-MRT, International Working Group-Myeloproliferative Neoplasms Research and Treatment; SEER, Surveillance, Epidemiology, and End Results.

§Progressive disease assignment for splenomegaly requires confirmation by computed tomography (CT) or magnetic resonance imaging (MRI) showing a ≥25% increase in spleen volume from baseline. Baseline values for both physical examination and imaging studies refer to pretreatment baseline and not to posttreatment measurements.6

Image of 3 bottles of Jakafi – Review Jakafi Dosing in Myelofibrosis

REVIEW JAKAFI DOSING
IN MYELOFIBROSIS

Image of 3 bottles of Jakafi – Review Jakafi Dosing in Myelofibrosis

REVIEW JAKAFI DOSING
IN MYELOFIBROSIS

References

  1. Barbui T, Barosi G, Birgegard G, et al. Philadelphia-negative classical myeloproliferative neoplasms: critical concepts and management recommendations from European LeukemiaNet. J Clin Oncol. 2011;29(6):761-770.
  2. Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 18 Regs Research Data + Hurricane Katrina Impacted Louisiana Cases, November 2015 Submission (1973-2013 varying) - Linked To County Attributes - Total U.S., 1969-2014 Counties. Accessed January 4, 2017.
  3. Cervantes F, Dupriez B, Pereira A, et al. New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and Treatment. Blood. 2009;113(13):2895-2901.
  4. Gangat N, Caramazza D, Vaidya R, et al. DIPSS plus: a refined Dynamic International Prognostic Scoring System for primary myelofibrosis that incorporates prognostic information from karyotype, platelet count, and transfusion status. J Clin Oncol. 2011;29(4):392-397.
  5. Passamonti F, Cervantes F, Vannucchi AM, et al. A dynamic prognostic model to predict survival in primary myelofibrosis: a study by the IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment). Blood. 2010;115(9):1703-1708.
  6. Tefferi A, Cervantes F, Mesa R, et al. Revised response criteria for myelofibrosis: International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) consensus report. Blood. 2013;122(8):1395-1398.
  7. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms V.1.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 4, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  8. Tremblay D, Schwartz M, Bakst R, et al. Modern management of splenomegaly in patients with myelofibrosis. Ann Hematol. 2020. doi.org/10.1007/s 00277-020-04069-4.
  9. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
  10. 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.
  11. Harrison C, Kiladjian J-J, Al-Ali HK, et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med. 2012;366(9):787-798.

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 (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

  • Treatment with Jakafi® (ruxolitinib) can cause thrombocytopenia, anemia and neutropenia, which are each dose-related effects. Perform a pre-treatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated
  • Manage thrombocytopenia by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary
  • Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi
  • Severe neutropenia (ANC <0.5 × 109/L) was generally reversible by withholding Jakafi until recovery
  • Serious bacterial, mycobacterial, fungal and viral infections have occurred. Delay starting Jakafi until active serious infections have resolved. Observe patients receiving Jakafi for signs and symptoms of infection and manage promptly. Use active surveillance and prophylactic antibiotics according to clinical guidelines
  • Tuberculosis (TB) infection has been reported. Observe patients taking Jakafi for signs and symptoms of active TB and manage promptly. Prior to initiating Jakafi, evaluate patients for TB risk factors and test those at higher risk for latent infection. Consult a physician with expertise in the treatment of TB before starting Jakafi in patients with evidence of active or latent TB. Continuation of Jakafi during treatment of active TB should be based on the overall risk-benefit determination
  • Progressive multifocal leukoencephalopathy (PML) has occurred with Jakafi treatment. If PML is suspected, stop Jakafi and evaluate
  • Advise patients about early signs and symptoms of herpes zoster and to seek early treatment
  • Increases in hepatitis B viral load with or without associated elevations in alanine aminotransferase and aspartate aminotransferase have been reported in patients with chronic hepatitis B virus (HBV) infections. Monitor and treat patients with chronic HBV infection according to clinical guidelines
  • When discontinuing Jakafi, myeloproliferative neoplasm-related symptoms may return within one week. After discontinuation, some patients with myelofibrosis have experienced fever, respiratory distress, hypotension, DIC, or multi-organ failure. If any of these occur after discontinuation or while tapering Jakafi, evaluate and treat any intercurrent illness and consider restarting or increasing the dose of Jakafi. Instruct patients not to interrupt or discontinue Jakafi without consulting their physician. When discontinuing or interrupting Jakafi for reasons other than thrombocytopenia or neutropenia, consider gradual tapering rather than abrupt discontinuation
  • Non-melanoma skin cancers (NMSC) including basal cell, squamous cell, and Merkel cell carcinoma have occurred. Perform periodic skin examinations
  • Treatment with Jakafi has been associated with increases in total cholesterol, low-density lipoprotein cholesterol, and triglycerides. Assess lipid parameters 8-12 weeks after initiating Jakafi. Monitor and treat according to clinical guidelines for the management of hyperlipidemia
  • Another JAK-inhibitor has increased the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and stroke (compared to those treated with tumor TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur
  • Another JAK-inhibitor has increased the risk of thrombosis, including deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. In patients with myelofibrosis (MF) and polycythemia vera (PV) treated with Jakafi in clinical trials, the rates of thromboembolic events were similar in Jakafi and control treated patients. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately
  • Another JAK-inhibitor has increased the risk of lymphoma and other malignancies excluding NMSC (compared to those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which Jakafi is not indicated. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Jakafi, particularly in patients with a known secondary malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers
  • In myelofibrosis and polycythemia vera, the most common nonhematologic adverse reactions (incidence ≥15%) were bruising, dizziness, headache, and diarrhea. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections (pathogen not specified) and edema. In chronic graft-versus-host disease, the most common nonhematologic adverse reactions (incidence ≥20%) were infections (pathogen not specified) and viral infections
  • Avoid concomitant use with fluconazole doses greater than 200 mg. Dose modifications may be required when administering Jakafi with fluconazole doses of 200 mg or less, or with strong CYP3A4 inhibitors, or in patients with renal or hepatic impairment. Patients should be closely monitored and the dose titrated based on safety and efficacy
  • Use of Jakafi during pregnancy is not recommended and should only be used if the potential benefit justifies the potential risk to the fetus. Women taking Jakafi should not breastfeed during treatment and for 2 weeks after the final dose

Please see Full Prescribing Information for Jakafi.

Jakafi and the Jakafi logo are registered trademarks of Incyte. All other trademarks are the property of their respective owners.
© 2014-2022, Incyte Corporation. MAT-JAK-03799  03/22

Jakafi and the Jakafi logo are registered trademarks of Incyte. All other trademarks are the property of their respective owners.
© 2014-2022, Incyte Corporation. MAT-JAK-03799  03/22