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The dose of Jakafi should be individualized in order to optimize the balance between safety and efficacy

A complete blood count (CBC) and platelet (PLT) count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized and then as clinically indicated.1 (See Getting started with Jakafi below.)

Consider a dose increase for insufficient response. (See Dose modifications based on insufficient response below.)

Consider a dose reduction for hemoglobin (Hb) <12 g/dL or PLT count <100 x 109/L. (See Dose modifications for safety below.)

Interrupt dose for anemia (Hb <8 g/dL), thrombocytopenia (PLT count <50 × 109/L), or neutropenia (absolute neutrophil count [ANC] <1.0 × 109/L), but consider restarting after recovery of the hematologic parameter(s) to acceptable levels. (See Treatment interruption and restarting dosing in PV below.)

For dose modifications for Special Populations, see Special Populations below.

The dose of Jakafi should be individualized in order to optimize the balance between safety and efficacy

A complete blood count (CBC) and platelet (PLT) count must be performed before initiating therapy, every 2 to 4 weeks until doses are stabilized and then as clinically indicated.1 (See Getting started with Jakafi below.)

Consider a dose increase for insufficient response. (See Dose modifications based on insufficient response below.)

Consider a dose reduction for hemoglobin (Hb) <12 g/dL or PLT count <100 x 109/L. (See Dose Modifications for Safety below.)

Interrupt dose for anemia (Hb <8 g/dL), thrombocytopenia (PLT count <50 × 109/L), or neutropenia (absolute neutrophil count [ANC] <1.0 × 109/L), but consider restarting after recovery of the hematologic parameter(s) to acceptable levels. (See Treatment interruption and restarting dosing in PV below.)

For dose modifications for Special Populations, see Special Populations below.

Getting started with Jakafi

Start, monitor, and optimize

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

Image of Jakafi bottle and steps to start dosing – 1=Start, 2=Monitor, 3=Optimize
1 START
1 START

For polycythemia vera (PV) in adults who have an inadequate response to or intolerance of hydroxyurea (HU), the recommended starting dose of Jakafi is 10 mg twice daily.1 A 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 the use of fluconazole doses of >200 mg daily with Jakafi1
  • 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 Hb, PLT, or neutrophil counts1
  • Additionally, dosing may be increased to achieve desired clinical response, if Hb, PLT, and neutrophil counts are adequate1
  • Interrupt treatment for bleeding1
  • Refer to the Full Prescribing Information for Jakafi for details on dose modification1

Dose modifications based on insufficient response

If the response is insufficient and PLT, 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
    • PLT count greater than the ULN range
    • Palpable spleen that is reduced <25% from baseline
  2. PLT count ≥140 × 109/L
  3. Hb ≥12 g/dL
  4. ANC ≥1.5 × 109/L

Dose modifications for safety

Dose reductions should be considered for Hb and PLT count decreases1:

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

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

Treatment interruption and restarting dosing

  • Interrupt treatment for Hb <8 g/dL, PLT counts <50 × 109/L, or ANC <1.0 × 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, PLT count, or ANC abnormality to determine the corresponding maximum restarting dose:

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

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, PLT 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

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 frequent monitoring of safety and efficacy
  • Avoid the use of fluconazole doses of >200 mg daily with Jakafi

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

Special populations: Dosing in patients with renal or hepatic impairment1

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

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

Special populations: Patients on dialysis

  • The recommended starting dose in patients with PV who have end-stage renal disease and are on dialysis is 10 mg once after dialysis session
  • 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

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.