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Getting Started With Jakafi in PV

Dose optimization is key to maintaining the balance of safety and efficacy.

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START with the appropriate dose

A complete blood count (CBC) and platelet (PLT) count must be performed before initiating therapy.1

A complete blood count (CBC) and platelet (PLT) count must be performed before initiating therapy.1

Image of 10 mg bottle of Jakafi Image of 10 mg bottle of Jakafi

Jakafi is also available in tablets of

Image of 5 mg, 15 mg, 20mg, 25mg
Image of 5 mg
Image of 15 mg
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MONITOR: Monitoring patients after initiation of Jakafi is essential

MONITOR: Monitoring patients after initiation of Jakafi is essential

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

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…of patients treated with Jakafi in the RESPONSE clinical trial in PV had dose adjustments from the recommended starting dose by week 322*

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OPTIMIZE: Individualize dosing of Jakafi to optimize the balance between safety and efficacy1

OPTIMIZE: Individualize dosing of Jakafi to optimize the balance between safety and efficacy1

Image with an arrow pointing up INCREASING DOSE FOR INSUFFICIENT RESPONSE
Image showing 2 groups of people – 1st group WEEK 8 - 37% (41/110); 2nd group WEEK 32 – 54% (59/110) – Percent of patients randomized to Jakafi in the phase 3 RESPONSE trial who increased from starting dose Image showing 2 groups of people – 1st group WEEK 8 - 37% (41/110); 2nd group WEEK 32 – 54% (59/110) – Percent of patients randomized to Jakafi in the phase 3 RESPONSE trial who increased from starting dose
Image with an arrow pointing down DECREASING DOSE FOR ANEMIA OR THROMBOCYTOPENIA
Image showing 2 groups of people – 1st group WEEK 8 - 5% (6/110); 2nd group WEEK 32 – 13% (14/110) – Percent of patients randomized to Jakafi in the phase 3 RESPONSE trial who decreased from starting dose Image showing 2 groups of people – 1st group WEEK 8 - 5% (6/110); 2nd group WEEK 32 – 13% (14/110) – Percent of patients randomized to Jakafi in the phase 3 RESPONSE trial who decreased from starting dose

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

Image that says 66% – 73 out of 110

…of patients randomized to Jakafi discontinued treatment due to an adverse event1,3

Image shows a hand in a stop sign INTERRUPTING/RESTARTING DOSING
Special populations:

Dosing in patients with renal or hepatic impairment1

Modify the dose of Jakafi accordingly in patients with moderate or severe renal impairment, patients with hepatic impairment, and patients on dialysis.

Image of chart showing Renal Impairment Status/Hepatic Impairment Status – Platelet Count Recommended Starting Dosage Image of chart showing Renal Impairment Status/Hepatic Impairment Status – Platelet Count Recommended Starting Dosage

CrCl, creatinine clearance.

Patients on dialysis

  • The recommended starting dose in patients with PV who have end-stage renal disease and are on dialysis is 10 mg
  • Additional dose modifications should be made with frequent monitoring of safety and efficacy
  • Avoid use of Jakafi in patients with end-stage renal disease (CrCl <15 mL/min) not requiring dialysis

Concomitant use with strong CYP3A4 inhibitors or fluconazole1

  • Modify the dose of Jakafi when coadministered with strong CYP3A4 inhibitors and fluconazole doses of ≤200 mg
  • Avoid the use of fluconazole doses of >200 mg daily with Jakafi
  • Additional dose modifications should be made with frequent monitoring of safety and efficacy
Image of chart showing Patients on Concomitant Strong CYP3A4 Inhibitors or Fluconazole Doses of ≤200mg – Recommended Dose Modification Image of chart showing Patients on Concomitant Strong CYP3A4 Inhibitors or Fluconazole Doses of ≤200mg – Recommended Dose Modification

For further information and to download the Jakafi dosing guide, click here.

  Video

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.

WATCH NOW

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*The phase 3 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

  1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
  2. Data on file. Incyte Corporation. Wilmington, DE.
  3. 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):426-435.

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

  • 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 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
  • In myelofibrosis and polycythemia vera, the three most common nonhematologic adverse reactions (incidence >10%) were bruising, dizziness and headache. In acute graft-versus-host disease, the most common nonhematologic adverse reactions (incidence >50%) were infections and edema
  • Dose modifications may be required 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.
© 2014-2019, Incyte Corporation. MAT-JAK-01411  11/19

Jakafi and the Jakafi logo are registered trademarks of Incyte.
All other trademarks are the property of their respective owners.
© 2014-2019, Incyte Corporation. MAT-JAK-01411  11/19