Polycythemia Vera

What Effects Has Jakafi Shown in Clinical Trials?


Understanding how Jakafi compared to other standard therapies in a clinical trial

In this video, Gary Grad, MD, describes how a targeted therapy called Jakafi® (ruxolitinib) was compared against other standard therapies in a clinical trial. Dr Grad explains the effects of the therapies on patients’ hematocrit control, other blood counts, and spleen size after 8 months of treatment. ...more

Video Transcript

Onscreen text and narrator: What Effects Has Jakafi® (ruxolitinib) Shown in Clinical Trials in Patients With Polycythemia Vera Who Have Taken Hydroxyurea and It Didn’t Work Well Enough?

Onscreen text and narrator: This video is intended for informational use only, and is not designed to replace the medical advice of your Healthcare Professional.

Onscreen text: Your Healthcare Professional is the best source for treatment-related questions and medical advice.

Dr Grad: Hi. I'm Dr Gary Grad, a hematologist-oncologist who specializes in the treatment of myeloproliferative neoplasms such as polycythemia vera, or PV.

Dr Grad: Jakafi® (ruxolitinib) is a prescription medication available as a pill.

Onscreen text: Jakafi® (ruxolitinib) is the first and only prescription medicine approved by the FDA to treat people with PV who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it. Important Safety Information is discussed later in this video.

Dr Grad: Jakafi is used to treat people with PV who have already taken hydroxyurea and it did not work well enough or they could not tolerate it.

Dr Grad: Jakafi is the first and only medicine approved by the Food and Drug Administration, or FDA, for the treatment of these patients.

Onscreen text: Clinical trials are also called “clinical studies”

Dr Grad: In order to better understand how medicines may work and what side effects they may cause, researchers perform clinical trials, often by comparing new treatments with existing treatments.

Onscreen text: Jakafi was compared against best available therapies, which included:

  • Hydroxyurea (HU)
  • Interferon
  • Other

Dr Grad: Jakafi was compared against other standard therapies in a clinical trial of patients with polycythemia vera who had already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it.

Onscreen text: Hematocrit or HCT is a measure of how much space red blood cells take up in your blood and is stated as a percentage.

Dr Grad: Hematocrit—or HCT—is a measure of how much space red blood cells take up in your blood and can be high in patients with PV.

Onscreen text: The combination of hematocrit (HCT) control and spleen volume reduction was the main goal (or primary endpoint) of this study.

Dr Grad: The main measure—or primary endpoint—of the study was a combination of the ability to keep hematocrit under control without the need for phlebotomy and the ability to reduce the volume of an enlarged spleen, which can be an issue in some patients with PV.

Onscreen text: Control of all 3 blood counts—HCT, white blood cells (WBCs), and platelets—was a secondary endpoint.

Dr Grad: A secondary endpoint of this clinical trial was the ability of the treatments to help control 3 different blood counts—HCT, white blood cells, and platelets—by keeping these counts below specified levels.

Onscreen text: Results from the clinical trial showed that Jakafi worked better than other standard treatments in terms of controlling HCT and reducing the spleen volume, as well as for keeping blood counts under control.

Dr Grad: In this clinical trial, after 8 months of treatment, Jakafi was shown to work better than other standard treatments in terms of controlling hematocrit and reducing spleen volume, as well as for keeping blood counts under control.

Dr Grad: In addition, many patients in the clinical trial who initially responded to Jakafi continued to respond at 20 months of treatment.

Dr Grad: If you have PV and are on—or have taken—hydroxyurea and it has not worked well enough for you or you cannot tolerate it, talk to your Healthcare Professional about whether Jakafi may be right for you.

Onscreen text: Only your Healthcare Professional can decide if Jakafi is right for you.

Dr Grad: To learn more about how patients responded to Jakafi in the clinical trial—and to learn if it may be right for you—be sure to talk with your Healthcare Professional.

Onscreen text and narrator: Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB) or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change your dose or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.

Onscreen text: Register now for information, support, and resources. Visit Jakafi.com/Register

Onscreen text: This video is sponsored by Incyte Corporation. Jakafi and the Jakafi logo are registered trademarks of Incyte. © 2019, Incyte Corporation. MAT-JAK-00387  03/19

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INDICATIONS AND USAGE

INDICATIONS AND USAGE

Jakafi is a prescription medicine used to treat adults with polycythemia vera who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it.

Jakafi is used to treat adults with certain types of myelofibrosis.

Jakafi is also used to treat adults and children 12 years of age and older with acute graft-versus-host disease (GVHD) who have taken corticosteroids and they did not work well enough.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: for certain types of MF and PV – low platelet or red blood cell counts, bruising, dizziness, and headache; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB) or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have high cholesterol or triglycerides, had skin cancer, or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change your dose or stop taking Jakafi without first talking to your healthcare provider.

Women should not take Jakafi while pregnant or planning to become pregnant. Do not breastfeed during treatment with Jakafi and for 2 weeks after the final dose.

Please see the Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You may also report side effects to Incyte Medical Information at 1-855-463-3463.