Myelofibrosis

Possible Benefits of Jakafi®


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

Jakafi has been shown to reduce spleen size and improve the core symptoms of myelofibrosis (MF) 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.


How was Jakafi studied?

In a clinical trial in patients 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

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 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.

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% 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% in 42% of people with MF when measured after 6 months of treatment. In contrast, less than 1% of people taking a placebo (sugar pill) reached that goal.

Also in this trial:

Graphic of clipboard showing 99%

99% 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 people 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% of the people taking Jakafi reached this goal, compared with only 5% of people taking placebo.

Also in this trial:

Approximately 80% 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.

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.


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


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.


What are possible side effects of Jakafi?

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi 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 Professional. Your Healthcare Professional will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your Healthcare Professional may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your Healthcare Professional 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 Professional 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 Professional if you develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood cholesterol levels. Your Healthcare Professional 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 Professional for more information. Tell your Healthcare Professional about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your Healthcare Professional 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 Professional tells you. Do not change your dose or stop taking Jakafi without first talking to your Healthcare Professional. 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.

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

Image of woman – Jakafi patient – talking on the phone, sitting on a park bench

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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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Important Safety Information

Indications and Usage

Jakafi is a prescription medicine used to treat people 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 also used to treat certain types of myelofibrosis.

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.