About Jakafi®

What is Jakafi?

Jakafi (JAK-ah-fye) is a prescription medicine available as a pill. Jakafi is used to treat people with polycythemia vera (PV) 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 (MF).

Jakafi is the first and only medicine approved by the Food and Drug Administration (FDA) for the treatment of these patients.

Learn about the clinical trials for Jakafi

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How does Jakafi work?

Polycythemia vera (PV) and myelofibrosis (MF) are complex conditions, and researchers are still trying to discover their exact causes. Evidence suggests that proteins known as Janus kinases, or JAKs, are involved. JAK proteins send signals that affect the production of blood cells in the bone marrow. When JAKs send too many signals, they cause the body to make the wrong number of blood cells. This chain of events is called overactive JAK signaling.

JAK signaling may become overactive in many ways. One way is by a JAK mutation. A mutation is a small change in the DNA that causes proteins to act differently than normally intended. All people with PV and MF are believed to have overactive JAK signaling even if they do not have a JAK mutation.

Jakafi works by targeting JAKs, which control the production of blood cells. In doing so, Jakafi reduces overactive JAK signaling.
PVContent

What are some possible benefits of Jakafi for patients with polycythemia vera (PV) who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it?

Jakafi was compared against other standard therapies in a clinical trial of patients with polycythemia vera (PV) who had already taken a medicine called hydroxyurea 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 (percentage of red blood cell volume) under control, while at the same time reducing spleen volume by at least 35%. Here are 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 kept their hematocrit under control and  had a reduction in spleen volume of at least 35%
  • 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
  • 40% of patients in the group receiving Jakafi had at least a 35% reduction in their spleen volume compared with <1% of patients who received other therapies

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 about how patients responded to Jakafi in the key clinical trial, and ask about the potential long-term effects of Jakafi treatment.

MFContent

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

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

How does Jakafi affect spleen size in MF?

Enlarged spleen

Many people with MF have enlarged spleens, 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.

In a clinical trial, 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, 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.

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 46% of the people taking Jakafi reached this goal, compared with only 5% of people taking placebo. In fact, 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.

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

Although every person taking Jakafi may not experience the same results, Jakafi may help reduce these core symptoms and the size of the spleen.

What long-term data for Jakafi are available for 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 with Jakafi or other MF treatments would be alive at 1, 2, and 3 years of treatment.

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 about how patients responded to Jakafi in the key clinical trials, and ask about the potential long-term effects of Jakafi treatment.

Is Jakafi a long-term treatment for MF?

Myelofibrosis is a chronic disease that progresses—or gets worse—over time. By taking Jakafi as prescribed by your Healthcare Professional, you may be able to continue receiving the benefits of this medicine. Once treatment with Jakafi stops, the spleen is expected to get bigger again, and symptoms are expected to return. The symptoms may return in as little as a week.

Your Healthcare Professional may allow up to 6 months to see if Jakafi is working to reduce the size of your spleen and to improve your symptoms. If you do not have a reduction in spleen size or an improvement in your symptoms after 6 months of treatment, your Healthcare Professional may have you stop taking Jakafi.

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 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.


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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.
 
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.

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.