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Clinical characteristics of advanced polycythemia (PV)

In a subset of patients, these characteristics may indicate advanced PV despite treatment with HU at the maximum tolerated dose and phlebotomy1-5

Image that says Hct ≥ 45% PLUS WBC COUNT > 11X10^9/L OR Disease-related SYMPTOMS (eg. splenomegaly)
Image of laptop computer – Review Jakafi Efficacy Data for PV

REVIEW JAKAFI EFFICACY
DATA FOR PV

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms

These clinical characteristics are also included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).

...actively monitoringa patients’ responseb and signs/symptoms of disease progression while on cytoreductive therapy6

The presence of any one of these factors may warrant a change in cytoreductive therapy

  • Intolerance or resistance to HU7 or interferon
  • Leukocytosis
  • Disease-related symptoms
  • New thrombosis or disease-related major bleeding
  • Thrombocytosis
  • Frequent and/or persistent need for phlebotomy, but with poor tolerance of phlebotomy
  • Splenomegaly
  • Jakafi is FDA approved for use in PV after inadequate response to or intolerance of HU8
  • The phase 3 RESPONSE study defined inadequate response to include the maximum tolerated dose of HU, not just the ELN criteria of 2 g/d, after 3 months7,9
  • RESPONSE was an open-label trial and therefore not designed to evaluate a difference in symptoms.1 Jakafi was also studied in a phase 3 trial evaluating symptom reduction vs HU and did not meet the primary end point10
  • The clinical effect of Jakafi on thrombosis has not been established
  • ELN=European LeukemiaNet; IWG-MRT=International Working Group-Myeloproliferative Neoplasms Research and Treatment.
    aEvery 3–6 months or more frequently as clinically indicated.
    bPer IWG-MRT and ELN response criteria.
Image of Patients not responding adequately to hydroxyurea? - Learn about Jakafi for these Patients

Patients not responding adequately to hydroxyurea?

LEARN ABOUT JAKAFI
FOR THESE PATIENTS

Image of 6+ YEARS

Experience with Jakafi
since FDA approval11*

MORE THAN 26,000 PATIENTS TREATED

*Estimated total patients treated with commercially available Jakafi in the US since 2011.11

  Video

Identifying Patients for Whom Jakafi Might Be Appropriate

How could polycythemia vera (PV) be managed in patients with an intolerance of or inadequate response to hydroxyurea? Hematologic malignancy expert Dr Harry Erba presents clinical considerations for identifying and managing such patients. In addition, Dr Erba reviews the data about Jakafi® (ruxolitinib) from the RESPONSE† trial.

WATCH NOW

†RESPONSE=Randomized study of Efficacy and Safety in POlycythemia vera with JAK iNhibitor ruxolitinib verSus bEst available care.

Image of Dr. Harry Erba
Image of laptop computer – Review Jakafi Efficacy Data for PV

REVIEW JAKAFI EFFICACY
DATA FOR PV

Image of 3 people – Identify Appropriate Patients for Jakafi

REVIEW JAKAFI EFFICACY
DATA FOR PV

References

  1. Barosi G, Birgegard G, Finazzi G, et al. A unified definition of clinical resistance and intolerance to hydroxycarbamide in polycythaemia vera and primary myelofibrosis: results of a European LeukemiaNet (ELN) consensus process. Br J Haematol. 2010;148(6):961-963.
  2. Marchioli R, Finazzi G, Specchia G, et al. Cardiovascular events and intensity of treatment in polycythemia vera. N Engl J Med. 2013;368(1):22-33.
  3. Barbui T, Masciulli A, Marfisi M. White blood cell counts and thrombosis in polycythemia vera: a subanalysis of the CYTO-PV study. Blood. 2015;126(4):560-561.
  4. Emanuel R, Dueck A, Geyer H, et al. Myeloproliferative neoplasm (MPN) symptom assessment form total symptom score: prospective international assessment of an abbreviated symptom burden scoring system among patients with MPNs. J Clin Oncol. 2012;30(33):4098-4103.
  5. Verstovsek S, Passamonti F, Rambaldi A, et al. A phase 2 study of ruxolitinib, an oral JAK1 and JAK2 Inhibitor, in patients with advanced polycythemia vera who are refractory or intolerant to hydroxyurea. Cancer. 2014;120(4):513-520.
  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms V.1.2019. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed September 4, 2018. 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.
  7. 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.
  8. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
  9. Vannucchi AM, Kiladjian JJ, Griesshammer M, et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015;372(5)(suppl):1-25.
  10. Mesa R, Vannucchi A, Yacoub A, et al. The efficacy and safety of continued hydroxycarbamide therapy versus switching to ruxolitinib in patients with polycythaemia vera: a randomized, double-blind, double-dummy, symptom study (RELIEF). Br J Haematol. 2017;176:76-85.
  11. Data on file. Incyte Corporation. Wilmington, DE.

Indications and Usage

Jakafi is indicated for treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is indicated for treatment of patients with intermediate or high‐risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF.

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
  • 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 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
  • The three most frequent non‐hematologic adverse reactions (incidence >10%) were bruising, dizziness and headache
  • A dose modification is recommended when administering Jakafi with strong CYP3A4 inhibitors or fluconazole 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 two 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.
© 2014-2018, Incyte Corporation. All rights reserved.
MAT-JAK-00067  11/18

Jakafi and the Jakafi logo are registered trademarks of Incyte.
All other trademarks are the property of their respective owners.
© 2014-2018, Incyte Corporation. All rights reserved.
MAT-JAK-00067  11/18