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Myelofibrosis

Possible Benefits of Jakafi


What are some possible benefits of Jakafi for adults with intermediate or high-risk myelofibrosis?

Jakafi® (ruxolitinib) has been shown to reduce spleen size and improve the core symptoms of myelofibrosis (MF)—including spleen-related symptoms—in some patients. Jakafi has also been shown to help improve fatigue-related symptoms in patients with MF.

Is Jakafi right for you?

Find out what it means to have intermediate or high-risk MF and discover if Jakafi may be a possible treatment option for you.

Did you know that an enlarged spleen is a common finding in people with MF?

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

How was Jakafi studied?

In a clinical trial in adults with intermediate or high-risk MF, treatment with Jakafi was compared with treatment with placebo (sugar pill). Patients were then watched to see whether either treatment resulted in a reduction in the size of the spleen and also a decrease in certain symptoms. Treatment with Jakafi was considered effective if it reduced spleen size by a set goal of at least 35%. This was the main study goal, or primary endpoint.

In this same trial, Jakafi was also said to work if people reached a goal of 50% or greater improvement in their Total Symptom Score, or TSS, after 6 months of treatment. This assessment was an additional goal (or secondary endpoint) of the study.

The MF symptoms included in the TSS were:

Abdominal discomfort* | Itching | Early feeling of fullness* | Night sweats | Pain under the left ribs* | Bone/muscle pain

*Symptoms related to an enlarged spleen

In a separate analysis of the same trial, researchers also looked at whether or not treatment with Jakafi helped improve fatigue-related symptoms in patients with MF.


What were the results of this clinical trial of Jakafi for the treatment of adults with certain types of MF?

The results of the clinical trial showed that Jakafi helped some patients reduce spleen size and improve the core symptoms of MF, including symptoms related to an enlarged spleen.

In a clinical trial:

 
Graphic of two circles – one is 42% vs the other circle showing <1% - showing that Jakafi reduced the size of the spleen by a set goal of at least 35% in 42% (65 of 155) of people with MF and <1% of people taking a placebo reached that goal.

Jakafi reduced the size of the spleen by a set goal of at least 35% (65 of 155) in 42% of people with MF when measured after 6 months of treatment. In contrast, less than 1% (1 of 154) of people taking a placebo (sugar pill) reached that goal.

 

Also in this trial:

Graphic of clipboard showing 99%

99% (150 of 155) of people on Jakafi had some response to therapy. This means that they had a reduction in spleen size even if it was less than the 35% goal achieved by some patients. In contrast, most patients receiving placebo experienced an increase in spleen size.

 
Graphic of spleen with arrows to represent spleen reduction.

Many people with MF have an enlarged spleen, which can cause symptoms such as abdominal discomfort, pain under the left ribs, and an early feeling of fullness. In adults with intermediate or high-risk MF, Jakafi may significantly reduce spleen size.


How does Jakafi affect symptoms in MF?

In that same clinical trial, Jakafi was also said to work if people reached a goal of 50% or greater improvement in their Total Symptom Score, or TSS, after 6 months of treatment.

The researchers found that:

Graphic of two circles – one is 46% vs the other circle showing 5% - showing that 46% of the people taking Jakafi reached this goal, compared to only 5% of people taking placebo.

46% (68 of 148) of the people taking Jakafi reached this goal, compared with only 5% (8 of 152) of people taking placebo.

 

Also in this trial:

Approximately 80% (116 of 145) of the patients taking Jakafi had some level of symptom improvement—even if it was less than 50%—while most of the people taking placebo actually saw their symptoms worsen.

 

Jakafi was also shown to reduce spleen-related symptoms

In the same clinical trial, Jakafi was also shown to reduce spleen-related symptoms in patients with MF. After 6 months of treatment, the percentage of patients with 50% or greater improvement in spleen-related symptoms included in the TSS was:

Early feeling of fullness

48% (69 of 155) of patients in the group that received Jakafi had early satiety (early feeling of fullness after eating) reduced by at least half compared with 11% (16 of 154) of patients in the group that received other treatments.

Pain under the left ribs

53% (72 of 155) of patients in the group that received Jakafi had pain under the left ribs reduced by at least half compared with 15% (21 of 154) of patients in the group that received other treatments.

Abdominal discomfort

48% (69 of 155) of patients in the group that received Jakafi had abdominal discomfort reduced by at least half compared with 9% (14 of 154) of patients in the group that received other treatments.

Icon of 2 people

Every person is unique. How your MF 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 trials and ask about the potential long-term effects of Jakafi treatment.


How does Jakafi help fatigue in MF?

In a separate analysis of the same trial, 35% of the patients taking Jakafi experienced improvement in their fatigue-related MF symptoms and in the associated impacts of fatigue on their daily activities, ie, work, self-care, and exercise.

By contrast, only 14% of patients in the placebo (sugar pill) group had a similar response.

 

Fatigue-related MF symptoms included:

Tiredness | Exhaustion | Mental tiredness | Lack of energy

Professional Perspective:

What Effects Has Jakafi Shown in Clinical Trials?

Learn about the results of two clinical studies that explored whether Jakafi® (ruxolitinib) reduced enlarged spleens in certain patients.

Watch Now

Are long-term data, including overall survival, available for Jakafi in the treatment of MF?

In key clinical trials for Jakafi, patients were followed for up to 3 years. One of the things the researchers looked at was the probability that patients taking Jakafi or other MF treatments would be alive at 1, 2, and 3 years of treatment.

While overall survival (OS)—or the probability that patients taking Jakafi would be alive after a certain period of time—was not the main goal (or primary endpoint) of the key clinical trials for Jakafi, these long-term data were captured as a secondary endpoint. These results are available in the Jakafi Prescribing Information and can be reviewed along with your Healthcare Professional.

Understanding these trials requires some knowledge about how they were designed. In the first trial, patients could initially receive either Jakafi or placebo (sugar pill). In the second trial, patients could initially receive either Jakafi or other therapies for the treatment of their MF.

Every person is unique. How you will respond to Jakafi depends on your individual circumstances. Talk to your Healthcare Professional about how patients responded to Jakafi in key clinical trials, including potential long-term effects of treatment with Jakafi.

Professional Perspective:

What Long-Term Data Are Available for Jakafi?

Learn more about the results of two clinical studies for Jakafi that researched spleen size and analyzed overall survival in certain types of MF.

Watch Now

What are possible side effects of Jakafi?

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will do a blood test 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.

Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with Jakafi. Your healthcare provider will regularly check your skin during your treatment with Jakafi. Tell your healthcare provider if you develop any new or changing skin lesions during treatment with Jakafi.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with Jakafi. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking Jakafi, and as needed.

Increased risk of major cardiovascular events such as heart attack, stroke or death in people who have cardiovascular risk factors and who are current or past smokers while using another JAK inhibitor to treat rheumatoid arthritis: Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Jakafi, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back, severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw, pain or discomfort in your arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort, breaking out in a cold sweat, nausea or vomiting, feeling lightheaded, weakness in one part or on one side of your body, slurred speech.

Increased risk of blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with Jakafi, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, shortness of breath or difficulty breathing.

Possible increased risk of new (secondary) cancers: People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers. People who smoke or who smoked in the past have an added risk of new cancers.

The most common side effects of Jakafi include: for certain types of myelofibrosis (MF) and polycythemia vera (PV) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea; for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling; and for chronic GVHD – low red blood cell or platelet counts and infections including viral infections.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

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 low white or red blood cell counts, have or had tuberculosis (TB) or have been in close contact with someone who has TB, had shingles (herpes zoster), have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have high cholesterol or triglycerides, had cancer, are a current or past smoker, had a blood clot, heart attack, other heart problems or stroke, 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.

Graphic that shows where the spleen is located in the body

Get facts about spleen enlargement in MF

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

Learn More
Image of Sue – Watch her story and learn how her MF symptoms affected her before she started taking Jakafi.

Learn how the symptoms of MF affected Sue before she started taking Jakafi.

Discover how Sue’s MF symptoms prompted her to talk to her Healthcare Professional about moving her treatment journey forward with Jakafi.

Watch Sue’s Story

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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 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.

Jakafi is also used to treat adults and children 12 years of age and older with chronic GVHD who have taken one or two types of treatments and they did not work well enough.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will do a blood test 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.

Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with Jakafi. Your healthcare provider will regularly check your skin during your treatment with Jakafi. Tell your healthcare provider if you develop any new or changing skin lesions during treatment with Jakafi.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with Jakafi. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking Jakafi, and as needed.

Increased risk of major cardiovascular events such as heart attack, stroke or death in people who have cardiovascular risk factors and who are current or past smokers while using another JAK inhibitor to treat rheumatoid arthritis: Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Jakafi, including: discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back, severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw, pain or discomfort in your arms, back, neck, jaw, or stomach, shortness of breath with or without chest discomfort, breaking out in a cold sweat, nausea or vomiting, feeling lightheaded, weakness in one part or on one side of your body, slurred speech.

Increased risk of blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with Jakafi, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, shortness of breath or difficulty breathing.

Possible increased risk of new (secondary) cancers: People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers. People who smoke or who smoked in the past have an added risk of new cancers.

The most common side effects of Jakafi include: for certain types of myelofibrosis (MF) and polycythemia vera (PV) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea; for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling; and for chronic GVHD – low red blood cell or platelet counts and infections including viral infections.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

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 low white or red blood cell counts, have or had tuberculosis (TB) or have been in close contact with someone who has TB, had shingles (herpes zoster), have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have high cholesterol or triglycerides, had cancer, are a current or past smoker, had a blood clot, heart attack, other heart problems or stroke, 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.