Polycythemia Vera Medication – Jakafi Benefits & Side Effects

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

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2. WHAT TO EXPECT

What Can I Expect When Taking Jakafi?

In clinical trials, how did Jakafi help adults with polycythemia vera who had already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it?

Remember, Jakafi® (ruxolitinib) may not work the same way in every person. Patients with polycythemia vera (PV) who did not benefit from or could not tolerate the chemotherapy drug hydroxyurea respond differently to treatment, and their disease progresses differently as well. While Jakafi may not work the same way in every person, you may experience an improvement in hematocrit control—reducing the need for phlebotomy—and reduced spleen size.

For more information about the possible benefits of Jakafi, click here to learn how patients in a clinical trial responded to Jakafi.

Explore the possible benefits of Jakafi

Learn how patients in a clinical trial responded to Jakafi.

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What should I watch for when taking Jakafi?

Jakafi can cause serious side effects including low blood counts and infection. Some people who take Jakafi have developed certain types of non‐melanoma skin cancers. Increases in blood cholesterol levels can also occur. In patients who took another JAK inhibitor to treat rheumatoid arthritis, there was an increased risk of potentially fatal cardiovascular events like heart attack or stroke in patients with risk factors for these events who smoke now or smoked in the past, as well as an increased risk of blood clots in legs or lungs and new (secondary) cancers like lymphoma, especially in patients who smoke now or smoked in the past.

The most common side effects of Jakafi for certain types of myelofibrosis and PV include: low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea. Call your doctor for medical advice about side effects.

To learn more about these and other risks, please read the Important Safety Information below and Full Prescribing Information.

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 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. Do not breastfeed during treatment with Jakafi or for 2 weeks after the final dose.

Take Jakafi exactly as your Healthcare Professional tells you. Do not change your dose or stop taking Jakafi without first talking to yourHealthcare Professional. Do not drink grapefruit juice while on Jakafi. Women should not take Jakafi while pregnant or planning to become pregnant.Do not breastfeed during treatment with Jakafi or for 2 weeks after the final dose.

How does Jakafi affect blood counts?

Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. Your Healthcare Professional will monitor your blood counts regularly once you start taking Jakafi. Your Healthcare Professional may lower your dose of Jakafi, temporarily stop Jakafi, or give blood transfusions if needed.

Jakafi may cause your platelet, red blood cell, or white blood cell counts to be lowered. Your Healthcare Professional will monitor your blood counts regularly once you start taking Jakafi. Your Healthcare Professional may lower your dose of Jakafi, temporarily stop Jakafi, or give blood transfusions if needed.

How long will I need to take Jakafi?

If your Healthcare Professional decides that Jakafi is right for you, it is important that you continue to take it as prescribed. Jakafi is a long-term treatment.

Your Healthcare Professional may allow up to 6 months to see if Jakafi is working for you. If you do not see an improvement after 6 months of treatment, your Healthcare Professional may have you stop taking Jakafi.

It is important to take Jakafi exactly as directed by your Healthcare Professional. Do not stop taking Jakafi without speaking with your Healthcare Professional. The only exception is that if you start bleeding, stop taking Jakafi and call your Healthcare Professional.

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Is Jakafi Long-Term Treatment?

Learn about the patients and conditions Jakafi is used to treat.

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How will my Healthcare Professional monitor me while I’m taking Jakafi?

Before you start treatment and periodically during treatment, your Healthcare Professional may perform a blood test called a complete blood count (CBC). The results of this test can help your Healthcare Professional:

• Monitor your blood counts during treatment to monitor the progression of your condition
• Adjust your dose of Jakafi, if necessary

Your Healthcare Professional may also perform regular physical examinations, update your medical history, or ask if you are taking any new medicines. In some cases, your Healthcare Professional may perform a bone marrow biopsy. This test involves taking a sample of your bone marrow with a needle. The results of this biopsy can tell your Healthcare Professional if you have any scar-like, or fibrous, tissue in your bone marrow, which may be a sign of progression to myelofibrosis.

It is important to talk to your Healthcare Professional about how you are feeling and how your condition is affecting you, even if you’re not sure that how you are feeling is caused by your condition.

Talking to your Healthcare Professional helps you both:

• Understand how your condition is affecting you
• Follow how your condition is changing over time
• Discuss options for managing your condition

Before you start treatment and periodically during treatment, your Healthcare Professional may perform a blood test called a complete blood count (CBC). The results of this test can help your Healthcare Professional:

• Monitor your blood counts during treatment to monitor the progression of your condition
• Adjust your dose of Jakafi, if necessary

Your Healthcare Professional may also perform regular physical examinations, update your medical history, or ask if you are taking any new medicines. In some cases, your Healthcare Professional may perform a bone marrow biopsy. This test involves taking a sample of your bone marrow with a needle. The results of this biopsy can tell your Healthcare Professional if you have any scar-like, or fibrous, tissue in your bone marrow, which may be a sign of progression to myelofibrosis.

It is important to talk to your Healthcare Professional about how you are feeling and how your condition is affecting you, even if you’re not sure that how you are feeling is caused by your condition.

Talking to your Healthcare Professional helps you both:

• Understand how your condition is affecting you
• Follow how your condition is changing over time
• Discuss options for managing your condition

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About Polycythemia Vera What Can I Expect When Taking Jakafi? Taking Jakafi

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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.

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