Polycythemia Vera

Possible Benefits of Jakafi


What are some possible benefits of Jakafi for 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® (ruxolitinib) may help control hematocrit (percentage of red blood cell volume) and reduce spleen size in adults with polycythemia vera (PV) who did not benefit from treatment with hydroxyurea (HU) or could not tolerate it.

Did you know that the spleen may become enlarged in people with PV?

Learn how you can help identify the signs and symptoms of spleen enlargement.

How was Jakafi studied?

Jakafi was compared against other standard therapies in a clinical trial of adults with PV who had already taken a medicine called HU and it did not work well enough or they could not tolerate it. Treatment was said to be effective if Jakafi kept a patient’s hematocrit level under control, while at the same time reducing spleen size by at least 35%.

The combination of these two measurements (hematocrit control and spleen size reduction) made up the primary endpoint, or the main goal, of the study.


What were the results of the clinical study of Jakafi for the treatment of PV?

After approximately 8 months of therapy:

Graphic of two circles – one is 23% vs the other circle showing <1% - displaying the results after approximately 8 months of therapy. 23% of patients in the group that received Jakafi compared with <1% of patients in the group that received other treatments.
Primary endpoint

23% of patients in the group that received Jakafi kept their hematocrit under control and had a reduction in spleen size of at least 35% compared with <1% of patients in the group that received other treatments

Graphic of two circles – one is 60% vs the other circle showing 19%. 60% of patients in the group that received Jakafi kept their hematocrit under control without phlebotomy.
Hematocrit portion of the primary endpoint

60% of patients in the Jakafi group kept their hematocrit under control without phlebotomy compared with 19% of patients in the group that received other therapies

 
Graphic of two circles – one is 40% vs the other circle showing <1%. 40% of patients in the group that received Jakafi had at least 35% reduction in their spleen size compared to <1% of patients who received other therapies.
Spleen size portion of the primary endpoint

40% of patients in the group receiving Jakafi had at least a 35% reduction in their spleen size compared with <1% of patients who received other therapies

Take an active role in identifying spleen enlargement in PV

Learn how you can partner with your Healthcare Professional to help identify the signs and symptoms of spleen enlargement in PV.

Professional Perspective:

What Effects Has Jakafi Shown in Clinical Trials?

Learn how targeted therapy with Jakafi affected patients’ hematocrit control, blood counts and spleen size after 8 months of treatment, when compared against other standard therapies.

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How does Jakafi affect blood counts?

Because PV can affect not only red blood cells, but also white blood cells and platelets, researchers looked at all 3 blood counts (red blood cells, white blood cells, and platelets) and whether Jakafi helped control them. This was a secondary goal (or secondary endpoint) of the clinical trial.

Results of the clinical trial demonstrated that more patients receiving Jakafi achieved the combined goal of hematocrit (HCT) control plus white blood cell (WBC) count and platelet count within goal ranges compared with other standard therapies. After approximately 8 months of therapy:

Graphic of two circles – one is 24% vs the other circle showing 8%. 24% of patients in the group that received Jakafi achieved HCT control and had WBC and platelet counts within goal ranges compared with 8% of patients who received other therapies.
24% of patients in the group receiving Jakafi achieved HCT control and had WBC and platelet counts within goal ranges compared with 8% of patients who received other therapies

Patient Perspectives: Cindy’s Story

image of Cindy

An unusually high hematocrit level led to Cindy’s diagnosis of PV. Learn how she moved her treatment journey forward with Jakafi.

What are some possible longer-term effects of Jakafi treatment?

Additional analyses of the key clinical trial for Jakafi were conducted at 20 months to look at the potential for PV patients to maintain the primary response of HCT control plus spleen size reduction of at least 35%.

Of the 25 patients who achieved the primary goal of hematocrit control plus spleen size reduction of at least 35% at 8 months:

Graphic showing 76% (19 of 25) maintained their response at approximately 20 months.

76% (19 of 25) maintained their response at approximately 20 months

Of the 66 patients who achieved hematocrit control at 8 months:

Graphic showing 77% (51 of 66) maintained hematocrit control at approximately 20 months.

77% (51 of 66) maintained hematocrit control at approximately 20 months

Of the 26 patients who achieved the secondary endpoint of HCT control and had WBC and platelet counts within goal range at 8 months:

Graphic showing 58% (15 of 26) maintained this response at approximately 20 months.

58% (15 of 26) maintained this response at approximately 20 months

Icon of 2 people

Every person is unique. How your PV progresses and how you will respond to Jakafi depends on your individual circumstances. Talk to your Healthcare Professional to learn more about how patients responded to Jakafi in the key clinical trial and ask about the potential long-term effects of Jakafi treatment.


What are possible side effects of Jakafi?

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, headache, and diarrhea; 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.

Image of a Healthcare Professional sittingat a desk talking with a patient about IncyteCARES – patient support program

Already taking Jakafi? IncyteCARES is a patient support program for people taking Jakafi that offers ongoing education and resources

IncyteCARES: Connecting to Access, Reimbursement, Education and Support

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Graphic that shows where the spleen is located in the body

Get facts about spleen enlargement in PV

Learn how you can partner with your Healthcare Professional to help identify and monitor the signs and symptoms of spleen enlargement in PV.

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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, headache, and diarrhea; 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.