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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 due to insufficient response in PV.

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Narrator: Dosing of Jakafi® (ruxolitinib) in patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea

Narrator: Jakafi® (ruxolitinib) is indicated for treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Dr Erba: Hello, my name is Harry Erba. I'm a professor of internal medicine at the University of Alabama at Birmingham where I serve as the director of the hematologic malignancies program as well as the associate director of the cancer center for clinical research. For the last 20 years, I have been a clinical investigator evaluating novel therapies for people with myeloid neoplasms including the myeloproliferative neoplasms.

Narrator: This promotional presentation is being sponsored by Incyte Corporation.

Dr Erba: We're going to speak about the labeled indication for Jakafi® (ruxolitinib) for patients with polycythemia vera who have had either an inadequate response to or are intolerant of hydroxyurea.

Dr Erba: The information that I will present is all consistent with the labeled indication and consistent with FDA regulations. We will also discuss important safety information regarding Jakafi.

Dr Erba: Now let's discuss the appropriate dosing of Jakafi in patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

The starting dose of Jakafi in this patient population is 10 mg twice daily. Now remember the drug is potentially myelosuppressive and so blood counts should be checked frequently at first, every two to four weeks, and as they stabilize as clinically indicated. Also remember that the dose of Jakafi should be adjusted based on tolerability and the goals of your therapy.

Dr Erba: Although the starting dose of Jakafi is 10 mg twice daily, remember it's important to optimize the dose of Jakafi to these patients. In the RESPONSE trial in the first eight weeks, 9% of patients required a dose reduction. But it’s also important to remember that 37% of patients in the first eight weeks actually had a dose increase of Jakafi in an effort to actually achieve the goals of therapy.

Dr Erba: Remember as well that Jakafi is cleared by renal-hepatic mechanisms and so patients with renal-hepatic insufficiency should be considered for lower starting doses of Jakafi. Jakafi is metabolized by CYP3A4 and so patients on CYP3A4 inhibitors, strong ones or even the moderately strong CYP3A4 inhibitor fluconazole, should have a lower starting dose if the CYP3A4 inhibitor cannot be stopped.

Dr Erba: The prescribing information for polycythemia vera indicates that you should consider dose reductions of Jakafi based on platelet counts and hemoglobin.

Dr Erba: And this should be followed so as to attempt to avoid abrupt discontinuation for a hemoglobin less than eight or a platelet count less than 50,000.

Dr Erba: Why would we consider increasing the dose of Jakafi? Well remember in patients who are being treated with Jakafi, we're trying to achieve certain goals.

Dr Erba: The dose of Jakafi can be increased in 5 mg twice-daily increments. The maximum dose of Jakafi is 25 mg twice daily.

A dose adjustment or dose increase should not be done in the first four weeks and no sooner than every two weeks.

Dr Erba: I would consider a dose increase for my patients up to the maximum dose of 25 mg twice daily if they require and continue to require phlebotomy, if they still have leukocytosis, thrombocytosis, or splenomegaly.

Dr Erba: As long as they have appropriate marrow reserve and so their hemoglobin isn't low and their platelets and neutrophils can tolerate a higher dose.

Dr Erba: But remember if the patient has cytopenias you should not go up on the dose. And so in patients who have low ANC or low platelet count this will keep us from going up on the dose in those situations.

A dose adjustment or dose increase should not be done in the first four weeks and no sooner than every two weeks.

Narrator: 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 ruxolitinib treatment for myelofibrosis. 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 breast‐feed

Please view Full Prescribing Information.

Dr Erba: Thank you for listening and watching this presentation on the appropriate dosing of Jakafi for patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

Image of the video Interactive Case Study - Uncontrolled Polycythemia Vera (PV) Inadequate Response to Hydroxyurea
Interactive Case Study | Uncontrolled Polycythemia Vera (PV) | Inadequate Response to Hydroxyurea

This video offers healthcare professionals the opportunity to participate in a clinical treatment challenge. Hematology specialist Dr Harry Erba presents the case of a patient with uncontrolled polycythemia vera despite treatment with hydroxyurea and invites clinicians to select an appropriate treatment strategy.

Image of Dr Harry Erba from the video Efficacy and Safety of Jakafi® (ruxolitinib) from the RESPONSE Trial
Efficacy and Safety of Jakafi® (ruxolitinib) From the RESPONSE* Trial

Dr Harry Erba, Director of the Hematologic Malignancy Program at the University of Alabama, reviews the efficacy and safety of Jakafi® (ruxolitinib) in polycythemia vera (PV). Dr Erba presents evidence from the RESPONSE* trial, which compared Jakafi to best available therapy for patients with PV who were either intolerant of or had an inadequate response to hydroxyurea.

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

Image of Dr Harry Erba from the video Uncontrolled Polycythemia Vera (PV) Inadequate Response to Hydroxyurea
Identifying Patients Whose Polycythemia Vera Is Uncontrolled With Hydroxyurea

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.

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

Image from the video Dosing of Jakafi® (ruxolitinib) in Patients With Polycythemia Vera Who Have Had an Inadequate Response to or Are Intolerant of Hydroxyurea
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 due to insufficient response in PV.

Illustration of Jakafi® (ruxolitinib) targeting hematopoietic cell proliferation due to an overactive JAK pathway signaling.
Mechanism of Action of Jakafi® (ruxolitinib)

Hematology specialist Dr Harry Erba reviews the mechanism of action of Jakafi® (ruxolitinib), a JAK1 and JAK2 inhibitor, highlighting how Jakafi works to inhibit overactive JAK pathway signaling. Dr Erba also discusses safety data from the RESPONSE* trial, which compared Jakafi to best available therapy for patients with polycythemia vera who were either intolerant of or had an inadequate response to hydroxyurea.

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

Image from the video The Pathogenesis of Polycythemia Vera
The Pathogenesis of Polycythemia Vera

This video illustrates the pathogenesis of polycythemia vera (PV), a myeloproliferative neoplasm that arises from overproduction of hematopoietic stem cells in the bone marrow. The cause of PV is unknown, but may be related to a mutation in the gene coding for the Janus-associated kinase 2 (JAK2) protein. The JAK-STAT pathway helps to regulate normal blood cell production. In PV, the JAK-STAT pathway becomes overactive, leading to an increased number of red blood cells, but overproduction of white blood cells and platelets may also occur. Understanding the cellular origins of PV may lead to further insights into its clinical manifestations, including symptomatology and potential for disease progression.

Jakafi® (ruxolitinib) Efficacy and Safety: The COMFORT* trials

In this video, Salman Fazal, MD, discusses two myelofibrosis clinical trials—the COMFORT I and COMFORT II trials. In addition to reviewing the study design for each, Dr Fazal highlights important efficacy and safety data in these trials. The data show efficacy and safety results of Jakafi® (ruxolitinib) in patients with intermediate-2 risk and high-risk myelofibrosis.

* COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment

Initial Dosing for Jakafi® (ruxolitinib) in Intermediate or High-Risk Myelofibrosis (MF)

Salman Fazal, MD, of the Allegheny Health Network Cancer Institute in Pittsburgh, discusses Jakafi® dosing recommendations in intermediate or high-risk myelofibrosis. Dr Fazal begins by reviewing the recommended starting dose of Jakafi, which is based on a patient’s baseline platelet count. Also discussed are dose modifications, dose reductions, and treatment interruptions for Jakafi in intermediate or high-risk myelofibrosis.

Risk Assessment in Patients With Myelofibrosis (MF)

In this video, Salman Fazal, MD, discusses two commonly employed scoring systems to help estimate prognosis in patients with myelofibrosis (MF)—the International Prognostic Scoring System (IPSS) and Dynamic International Prognostic Scoring System (DIPSS). When evaluated by these risk assessment tools, the majority of patients with MF are found to have either intermediate or high-risk MF. Using IPSS and DIPSS, healthcare providers can accurately determine the risk category of their patients with MF and engage in meaningful discussions about survival and treatment options.

Next: Mechanism of Action of Jakafi® (ruxolitinib)

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 x 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.

 
IMPORTANT SAFETY INFORMATION
 
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 x 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.