Dosing for Jakafi in Polycythemia Vera

START, MONITOR,
AND OPTIMIZE
DOSE MODIFICATIONS
FOR SAFETY
OPTIMIZING DOSE
FOR EFFICACY
SPECIAL
POPULATIONS

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How is Jakafi dosed
in PV?
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Start, monitor,
and optimize

Start, monitor, and optimize

In 3 steps you can start, monitor, and optimize Jakafi dosing for your patients:

1 START

For patients with polycythemia vera (PV) who have an inadequate response to or intolerance of hydroxyurea (HU), the recommended starting dose of Jakafi is 10 mg twice daily.¹ A complete blood count (CBC) must be performed before initiating Jakafi treatment for your patients.

Special Populations:

For patients with renal or hepatic impairment or receiving concomitant strong CYP3A4 inhibitors or fluconazole, please refer to the Full Prescribing Information for starting dose, other dose modifications, and when to avoid treatment with Jakafi.

Avoid fluconazole doses of >200 mg daily¹
Avoid use of Jakafi in patients with end-stage renal disease (creatinine clearance, <15 mL/min) not requiring dialysis¹

2 MONITOR

A CBC must be performed before initiating Jakafi, every 2 to 4 weeks until doses are stabilized and then as clinically indicated.¹

3 OPTIMIZE

Individualize dosing of Jakafi to optimize balance between safety and efficacy.¹

Dosing may be reduced or temporarily interrupted based on decreases in hemoglobin, platelet, or neutrophil counts¹
Additionally, dosing may be increased to achieve desired clinical response, if hemoglobin, platelet, and neutrophil counts are adequate¹
Interrupt treatment for bleeding¹
Refer to the Full Prescribing Information for Jakafi for details on dose modification¹

DOSE MODIFICATIONS
FOR SAFETY

Dose modifications in polycythemia vera (PV)

Dose reductions should be considered for hemoglobin (Hb) and platelet count decreases¹:

Image of chart showing Hemoglobin and/or Platelet Count – Dosing Recommendations

Treatment interruption and restarting dosing in PV

Interrupt treatment for Hb <8 g/dL, platelet counts <50 × 10⁹/L, or absolute neutrophil count (ANC) <1 × 10⁹/L¹
After recovery of hematologic parameter(s) to acceptable levels, dosing may be restarted¹

PV: Restarting doses of Jakafi after safety interruption for hematologic parameter(s)

Use the most severe category of patients’ Hb, platelet count, or ANC abnormality to determine the corresponding maximum restarting dose:

Image of chart showing Hemoglobin, Platelet Count or ANC – Dosing Recommendations

Patients who had required dose interruption while receiving a dose of 5 mg twice daily may restart at a dose of 5 mg twice daily or 5 mg once daily—but not higher—once Hb is ≥10 g/dL, platelet count is ≥75 × 10⁹/L, and ANC is ≥1.5 × 10⁹/L.¹

Dose management after restarting treatment in PV

After restarting Jakafi following treatment interruption, doses may be titrated, but the maximum total daily dose should not exceed 5 mg less than the dose that resulted in the dose interruption. An exception to this is dose interruption following phlebotomy-associated anemia, in which case the maximal total daily dose allowed after restarting Jakafi would not be limited.¹

OPTIMIZING DOSE
FOR EFFICACY

Dose modifications based on insufficient response for patients with polycythemia vera (PV)

If the response is insufficient and platelet, hemoglobin (Hb), and neutrophil counts are adequate, doses may be increased in 5-mg-twice-daily increments to a maximum of 25 mg twice daily. Doses should not be increased during the first 4 weeks of therapy and not more frequently than every 2 weeks.¹

Consider dose increases in patients who meet all of these criteria¹

1. Inadequate efficacy as demonstrated by one or more of the following:
- Continued need for phlebotomy
- White blood cell count greater than the upper limit of normal (ULN) range
- Platelet count greater than the ULN range
- Palpable spleen that is reduced <25% from baseline
2. Platelet count ≥140 × 10⁹/L
3. Hb ≥12 g/dL
4. ANC ≥1.5 × 10⁹/L

SPECIAL
POPULATIONS

Special populations: 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 as follows.

Additional dose modifications should be made with careful monitoring of safety and efficacy
Avoid the use of fluconazole doses of >200 mg daily concomitantly with Jakafi

Image of chart showing Patients on Concomitant Strong CYP3A4 Inhibitors or Fluconazole Doses of ≤200mg – Recommended Dose Modification

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

Special populations: Patients on dialysis

The recommended starting dose in patients with polycythemia vera 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

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

GET THE JAKAFI DOSING GUIDE

Reference

Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.

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

Individualized Dosingfor Jakafi in Polycythemia Vera

Start, monitor, and optimize

Dose modifications in polycythemia vera (PV)

Treatment interruption and restarting dosing in PV

PV: Restarting doses of Jakafi after safety interruption for hematologic parameter(s)

Dose management after restarting treatment in PV

Dose modifications based on insufficient response for patients with polycythemia vera (PV)

Consider dose increases in patients who meet all of these criteria1

Special populations: Concomitant use with strong CYP3A4 inhibitors or fluconazole1

Special populations: Dosing in patients with renal or hepatic impairment1

Special populations: Patients on dialysis

Video

Individualized Dosing
for Jakafi in Polycythemia Vera

Consider dose increases in patients who meet all of these criteria¹

Special populations: Concomitant use with strong CYP3A4 inhibitors or fluconazole¹

Special populations: Dosing in patients with renal or hepatic impairment¹