Dose optimization is key to maintaining the balance between safety and efficacy

1
START

For adults with intermediate- or high-risk MF, the recommended starting doses are based on platelet counts1

A CBC, including platelet count, must be performed before initiating Jakafi® (ruxolitinib)1

  • Platelet count of 50 to <100 × 109/L: 5 mg BID
  • Platelet count of 100 to 200 × 109/L: 15 mg BID
  • Platelet count >200 × 109/L: 20 mg BID
Jakafi 5 mg, 15 mg, and 20 mg tablet bottles

Jakafi is also available in 10-mg and 25-mg tablets.

Special populations: Please refer to the Full Prescribing Information for starting dose and other dose modifications, and for when to avoid treatment in patients with renal or hepatic impairment and in those receiving concomitant strong CYP3A4 inhibitors or fluconazole.

 
2
MONITOR

Monitoring patients after initiation of Jakafi is essential, especially during the first 12 weeks of therapy1

  • A CBC and platelet count must be performed every 2 to 4 weeks until doses are stabilized, and then as clinically indicated. Doses may be titrated based on safety and efficacy
  • 70% of patients receiving Jakafi in COMFORT-I required a dose adjustment in the first 12 weeks of therapy2
 
3
OPTIMIZE

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

Managing anemia and thrombocytopenia

  • In COMFORT-I, grades 3 and 4 thrombocytopenia or anemia occurred in 13% and 45% of patients receiving Jakafi, respectively. All grades of thrombocytopenia or anemia occurred in 70% and 96% of patients receiving Jakafi, respectively1,3
  • Dose modifications, temporarily withholding Jakafi, and/or transfusions may be required for patients developing anemia or thrombocytopenia1
  • Interrupt treatment for bleeding, neutropenia (ANC <0.5 × 109/L), or thrombocytopenia (based on starting platelet count)1

ANC=absolute neutrophil count; CBC=complete blood count; COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin; MF=myelofibrosis.

There are no contraindications for use of Jakafi, including in patients with anemia1

In COMFORT-I, 46% of patients receiving Jakafi had anemia at baseline; among these patients, mean Hb was 9.2 g/dL (range, 6.6 g/dL to 13.7 g/dL)4

Dose may be increased in the case of an insufficient response1

Efficacy based on titrated dose

COMFORT-I: Mean Change in Spleen Volume by Dose at Week 242
COMFORT-I mean change in dose volume chart

This material is under a CC BY-NC License and is the property of the Ferrata Storti Foundation. © 2023 Ferrata Storti Foundation. All rights reserved.

  • Doses may be increased if the response is insufficient and platelet and neutrophil counts are adequate and treatment has not been reduced or interrupted in the prior 4 weeks1
  • Doses should not be increased during the first 4 weeks of therapy and not more frequently than every 2 weeks1
  • Discontinue Jakafi if there is no spleen size reduction or symptom improvement after 6 months of therapy1
  • In patients with starting platelet counts ≥100 × 109/L, based on limited clinical data, long-term maintenance at a 5-mg BID dose has not shown responses. Continued use at this dose should be limited to patients in whom the benefits outweigh the potential risks1

COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment.

Dosing in COMFORT-I1

  • Treatment with Jakafi can cause thrombocytopenia, anemia, and neutropenia, which are each dose-related effects. Perform a pretreatment 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

Anemia clinical trial data

Dose modifications of Jakafi and/or blood transfusions may be required for patients developing anemia1

  • In patients receiving Jakafi in the COMFORT studies, mean decreases in Hb levels reached a nadir of approximately 1.5 g/dL to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to a new steady state that was approximately 1.0 g/dL below baseline1
  • In COMFORT-I, 60% of patients treated with Jakafi and 38% of patients receiving placebo had RBC transfusions during randomized treatment1
COMFORT-I: Mean Hb Levels Over Time3
COMFORT-I Mean Hb Levels Graph

From The New England Journal of Medicine, Verstovsek S, Mesa RA, Gotlib J, et al, A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis, 2012;366(9):799-807. Supplementary appendix available at: doi:10.1056/NEJMoa1110557. Copyright © 2012 Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.

  • In COMFORT-I, grade 3 or 4 anemia occurred in 45% of patients receiving Jakafi1
  • <1% of patients receiving Jakafi in the COMFORT studies discontinued due to anemia or thrombocytopenia3
COMFORT-I: Patients Requiring RBC Transfusions2
COMFORT-I Patients Requiring RBC Transfusions Graph

This material is under a CC BY-NC License and is the property of the Ferrata Storti Foundation. © 2023 Ferrata Storti Foundation. All rights reserved.

ANC=absolute neutrophil count; CBC=complete blood count; COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin; RBC=red blood cell; SEM=standard error of the mean.

Thrombocytopenia clinical trial data

In patients with cytopenias, consider dose reductions, temporarily withholding Jakafi, or transfusions as clinically indicated.1

Monitor CBCs during treatment, beginning as early as weeks 2 to 4.1

COMFORT-I: Mean Platelet Counts Over Time4
COMFORT-I Mean Platelet Counts Graph

aProtocol-mandated dose modifications occurred based on platelet count.

  • In COMFORT-I, grade 3 or 4 thrombocytopenia occurred in 13% of patients receiving Jakafi1
  • Initial reductions in Hb and platelets can occur in as early as 2 to 4 weeks3,4
  • Dosing may need to be modified to avoid dose interruption, with the goal of achieving clinical benefit1

CBC=complete blood count; COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin; LLN=lower limit of normal.

Appropriate dose management

Dose modifications for patients with starting platelet count ≥100 × 109/L1

In the case of a hematologic toxicity, including:

Thrombocytopenia

Discontinuations can be avoided by reducing the dose or temporarily withholding Jakafi.

Dose modifications for hematologic toxicity ≥100 x 10^9/L chart

In patients receiving Jakafi in the COMFORT studies, platelet counts and Hb levels generally stabilized after 8 to 12 weeks3,4

Anemia
Dose modifications of Jakafi and/or blood transfusions may be required for patients developing anemia.1

COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin.

Interrupt Jakafi treatment for:

  • Bleeding requiring intervention, regardless of current platelet count,
  • Thrombocytopenia (platelet count <50 × 109/L), or
  • Neutropenia (ANC <0.5 × 109/L)

Restarting after treatment interruption

  • After recovery of platelet counts >50 × 109/L and ANC >0.75 × 109/L, dosing may be restarted
  • The maximum allowable dose that may be used in restarting Jakafi after a previous interruption is shown below

Maximum restarting doses for Jakafi after safety interruption for thrombocytopenia

Dose modifications for hematologic toxicity ≥100 x 10^9/L chart

aMaximum doses are displayed. When restarting, begin with a dose ≥5 mg BID below the dose at interruption.

  • Following treatment interruption for ANC <0.5 × 109/L, after ANC recovers to >0.75 × 109/L, restart dosing at the higher of 5 mg once daily or 5 mg BID below the largest dose in the week prior to the treatment interruption

ANC=absolute neutrophil count.

Increasing dose for insufficient response

In the case of an insufficient response, consider an increase in the dose if patient meets all of these criteria:

  • Insufficient spleen reduction*
  • Platelet count >125 × 109/L at 4 weeks and never <100 × 109/L
  • ANC >0.75 × 109/L

*Failure to achieve a reduction from pretreatment baseline in either palpable spleen length of 50% or spleen volume of 35% as measured by CT or MRI.

Increase dose by increments of 5 mg BID to a maximum of 25 mg BID

Doses should not be increased during the first 4 weeks of therapy and should not be increased more frequently than every 2 weeks.

Discontinue Jakafi if there is no spleen size reduction or symptom improvement after 6 months of therapy.

ANC=absolute neutrophil count; CT=computed tomography; MRI=magnetic resonance imaging.

Appropriate dose management

Dose modifications for patients with starting platelet count ≥100 × 109/L1

In the case of a hematologic toxicity, including:

Thrombocytopenia

Discontinuations can be avoided by reducing the dose or temporarily withholding Jakafi.

Dose modifications for hematologic toxicity ≥100 x 10^9/L chart

In patients receiving Jakafi in the COMFORT studies, platelet counts and Hb levels generally stabilized after 8 to 12 weeks3,4

Anemia
Dose modifications of Jakafi and/or blood transfusions may be required for patients developing anemia.1

COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; Hb=hemoglobin.

Interrupt Jakafi treatment for:

  • Bleeding requiring intervention, regardless of current platelet count,
  • Thrombocytopenia (platelet count <50 × 109/L), or
  • Neutropenia (ANC <0.5 × 109/L)

Restarting after treatment interruption

  • After recovery of platelet counts >50 × 109/L and ANC >0.75 × 109/L, dosing may be restarted
  • The maximum allowable dose that may be used in restarting Jakafi after a previous interruption is shown below

Maximum restarting doses for Jakafi after safety interruption for thrombocytopenia

Dose modifications for hematologic toxicity ≥100 x 10^9/L chart

aMaximum doses are displayed. When restarting, begin with a dose ≥5 mg BID below the dose at interruption.

  • Following treatment interruption for ANC <0.5 × 109/L, after ANC recovers to >0.75 × 109/L, restart dosing at the higher of 5 mg once daily or 5 mg BID below the largest dose in the week prior to the treatment interruption

ANC=absolute neutrophil count.

Increasing dose for insufficient response

In the case of an insufficient response, consider an increase in the dose if patient meets all of these criteria:

  • Insufficient spleen reduction*
  • Platelet count >125 × 109/L at 4 weeks and never <100 × 109/L
  • ANC >0.75 × 109/L

*Failure to achieve a reduction from pretreatment baseline in either palpable spleen length of 50% or spleen volume of 35% as measured by CT or MRI.

Increase dose by increments of 5 mg BID to a maximum of 25 mg BID

Doses should not be increased during the first 4 weeks of therapy and should not be increased more frequently than every 2 weeks.

Discontinue Jakafi if there is no spleen size reduction or symptom improvement after 6 months of therapy.

ANC=absolute neutrophil count; CT=computed tomography; MRI=magnetic resonance imaging.

Dose modifications for patients with starting platelet count of 50 to <100 × 109/L1

Decreasing dose for hematologic toxicity

Reduce the dose of Jakafi in patients with platelet counts <35 × 109/L.

Dose modifications for hematologic toxicity 50 to <100 x 10^9/L chart

Interrupt Jakafi treatment for:

  • Bleeding requiring intervention, regardless of current platelet count,
  • Platelet counts <25 × 109/L, or
  • ANC <0.5 × 109/L

Restarting after treatment interruption

Restart dosing after recovery of platelet counts to >35 × 109/L and ANC <0.75 × 109/L at the higher of:

  • 5 mg once daily or
  • 5 mg BID below the largest dose in the week prior to the decrease in platelet count below 25 × 109/L or ANC below 0.5 × 109/L that led to dose interruption

ANC=absolute neutrophil count.

The recommended starting dose in MF for patients with a starting platelet count of 50 to <100 x 109/L is 5 mg BID

Increasing dose for insufficient response

In the case of an insufficient response, consider an increase in the dose only after the first 4 weeks of therapy and not more frequently than every 2 weeks if patients meet all of these criteria:

  • Insufficient spleen reduction*
  • Platelet count has remained ≥40 × 109/L at 4 weeks and has not decreased by >20% in the prior 4 weeks
  • ANC >1.0 × 109/L
  • No dose reduction or interruption for an AE or hematological toxicity in the prior 4 weeks

*Failure to achieve a reduction from pretreatment baseline in either palpable spleen length of 50% or spleen volume of 35% as measured by CT or MRI.

Increase dose by increments of 5 mg daily to a maximum of 10 mg BID

Continuation of treatment for more than 6 months should be limited to patients in whom the benefits outweigh the risks.

Discontinue Jakafi if there is no spleen size reduction or symptom improvement after 6 months of therapy.

AE=adverse event; ANC=absolute neutrophil count; CT=computed tomography; MF=myelofibrosis; MRI=magnetic resonance imaging.

Dose modifications for patients with starting platelet count of 50 to <100 × 109/L1

Decreasing dose for hematologic toxicity

Reduce the dose of Jakafi in patients with platelet counts <35 × 109/L.

Dose modifications for hematologic toxicity 50 to <100 x 10^9/L chart

Interrupt Jakafi treatment for:

  • Bleeding requiring intervention, regardless of current platelet count,
  • Platelet counts <25 × 109/L, or
  • ANC <0.5 × 109/L

Restarting after treatment interruption

Restart dosing after recovery of platelet counts to >35 × 109/L and ANC <0.75 × 109/L at the higher of:

  • 5 mg once daily or
  • 5 mg BID below the largest dose in the week prior to the decrease in platelet count below 25 × 109/L or ANC below 0.5 × 109/L that led to dose interruption

ANC=absolute neutrophil count.

The recommended starting dose in MF for patients with a starting platelet count of 50 to <100 x 109/L is 5 mg BID

Increasing dose for insufficient response

In the case of an insufficient response, consider an increase in the dose only after the first 4 weeks of therapy and not more frequently than every 2 weeks if patients meet all of these criteria:

  • Insufficient spleen reduction*
  • Platelet count has remained ≥40 × 109/L at 4 weeks and has not decreased by >20% in the prior 4 weeks
  • ANC >1.0 × 109/L
  • No dose reduction or interruption for an AE or hematological toxicity in the prior 4 weeks

*Failure to achieve a reduction from pretreatment baseline in either palpable spleen length of 50% or spleen volume of 35% as measured by CT or MRI.

Increase dose by increments of 5 mg daily to a maximum of 10 mg BID

Continuation of treatment for more than 6 months should be limited to patients in whom the benefits outweigh the risks.

Discontinue Jakafi if there is no spleen size reduction or symptom improvement after 6 months of therapy.

AE=adverse event; ANC=absolute neutrophil count; CT=computed tomography; MF=myelofibrosis; MRI=magnetic resonance imaging.

Dose modification for bleeding1

Interrupt treatment for bleeding requiring intervention regardless of current platelet count. Once the bleeding event has resolved, consider resuming treatment at the prior dose if the underlying cause of bleeding has been controlled. If the bleeding event has resolved but the underlying cause persists, consider resuming treatment with Jakafi at a lower dose.

Dose modifications for special populations1

Dose modifications in patients with renal or hepatic impairment, or when coadministered with strong CYP3A4 inhibitors or fluconazole

Dose modification chart for patients coadministered strong CYP3A4 inhibitors or flucanozole doses ≤200 mg table

Patients with ESRD on dialysis

  • The recommended starting dose in patients with MF who have ESRD (CLcr <15 mL/min) and are on dialysis is:
    • 15 mg once after a dialysis session for patients with a platelet count between 100 × 109/L and 200 × 109/L
    • 20 mg once after a dialysis session for patients with a platelet count >200 × 109/L
  • Additional dose modifications should be made with frequent monitoring of safety and efficacy
  • Avoid use of Jakafi in patients with ESRD (CLcr <15 mL/min) not requiring dialysis

Concomitant use with strong CYP3A4 inhibitors or fluconazole

  • Modify the dose of Jakafi when coadministered with strong CYP3A4 inhibitors and fluconazole doses of ≤200 mg
  • Avoid the use of fluconazole doses >200 mg daily with Jakafi
  • Additional dose modifications should be made with frequent monitoring of safety and efficacy
Dose modification chart for patients coadministered strong CYP3A4 inhibitors or flucanozole doses ≤200 mg table
EXPLORE SVR AND
5-YEAR OS DATA HEAR FROM MPN EXPERTS

BID=twice daily; CLcr=creatinine clearance; ESRD=end-stage renal disease; MPN=myeloproliferative neoplasm; OS=overall survival; SVR=spleen volume reduction.

References: 1. Jakafi [package insert]. Wilmington, DE: Incyte Corporation. 2. Verstovsek S, Mesa RA, Gotlib J, et al. Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica. 2013;98(12):1865-1871. Supplementary appendix available at: https://haematologica.org/article/view/6861. 3. 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. Supplementary appendix available at: https://www.nejm.org/doi/full/10.1056/nejmoa1110557. 4. Data on file. Incyte Corporation. Wilmington, DE.

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Indications and Usage

Jakafi® (ruxolitinib) 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 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
  • Herpes zoster infection has been reported in patients receiving Jakafi. Advise patients about early signs and symptoms of herpes zoster and to seek early treatment. Herpes simplex virus reactivation and/or dissemination has been reported in patients receiving Jakafi. Monitor patients for the development of herpes simplex infections. If a patient develops evidence of dissemination of herpes simplex, consider interrupting treatment with Jakafi; patients should be promptly treated and monitored according to clinical guidelines
  • 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.

Indications and Usage

Jakafi® (ruxolitinib) 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 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
  • Herpes zoster infection has been reported in patients receiving Jakafi. Advise patients about early signs and symptoms of herpes zoster and to seek early treatment. Herpes simplex virus reactivation and/or dissemination has been reported in patients receiving Jakafi. Monitor patients for the development of herpes simplex infections. If a patient develops evidence of dissemination of herpes simplex, consider interrupting treatment with Jakafi; patients should be promptly treated and monitored according to clinical guidelines
  • 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.