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For adults and children 12 years of age and older who have taken one or two types of treatments and they did not work well enough

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What to Expect When Taking Jakafi: Dosing, Monitoring, and More


Exploring dosing, monitoring, and more

Explore how and when to take Jakafi® (ruxolitinib) and how Healthcare Professionals monitor the medication during treatment.

Video Transcript

Onscreen text and narrator: What to Expect When Taking Jakafi® (ruxolitinib): Dosing, Monitoring, and More

Onscreen text and narrator: Jakafi® (ruxolitinib) is the first and only prescription medicine approved by the FDA 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 is discussed later in this video.

Onscreen text and narrator: This video is intended for informational use only and is not medical advice. Your Healthcare Professional is the best source for treatment-related questions and medical advice.

Emily: Hi. I’m Emily Knight, an oncology clinical nurse educator for Incyte. For more than 14 years prior to joining Incyte, I worked with patients who had cancer, as well as patients who had stem cell transplants, including those who experienced acute graft-versus-host disease, or GVHD.

Emily: If you’ve been prescribed Jakafi, also known as ruxolitinib, you may be wondering how to take it, what testing is done along the way, and what kind of side effects some people encounter. In this video, I’ll walk you through these topics.

Emily: Jakafi is a pill you take by mouth. You can take it with or without food.

Emily: It’s a good idea to take your Jakafi at about the same time each day to help you remember. You might even tie it to another daily habit you have, like brushing your teeth.

Emily: Your Healthcare Professional will prescribe a starting dose of Jakafi that’s right for you.
From there, he or she may adjust your dose based on how you are responding to treatment and whether you are experiencing any side effects.

Emily: During Jakafi therapy, your Healthcare Professional will order blood tests for you. These are done to check your blood counts, cholesterol levels, and your liver function. Jakafi can affect these.

Emily: If the tests show that your blood counts are too low or that your liver function isn’t where it should be, your Healthcare Professional may decide to lower your dose of Jakafi. Or he or she may have you stop taking it for a while.

Onscreen text: Call your Healthcare Professional right away if you notice any new or worsening symptoms.

Emily: During treatment with Jakafi, you should always call your Healthcare Professional right away if you notice any new or worsening symptoms – even if you’re not sure they’re related to acute GVHD.

Emily: It’s also possible that your Healthcare Professional may increase your dose of Jakafi, if your blood counts are not decreased and your Healthcare Professional thinks your acute GVHD might improve with a higher dose.

Emily: While dose changes may be common with Jakafi treatment, it’s really important not to make changes or stop taking it on your own without first talking to your Healthcare Professional. However, if you develop bleeding, stop taking Jakafi and call your HCP.

Emily: Everyone taking Jakafi has different needs. So how long you might take Jakafi depends on your own results.
If you’ve been taking Jakafi for 6 months to treat your steroid-refractory acute GVHD with good results, and you’ve stopped taking steroids, your Healthcare Professional may start to gradually lower your Jakafi dose.

If your symptoms worsen or come back during this gradual lowering, your Healthcare Professional may increase your Jakafi dose again to address them.

Emily: Now, let’s talk a little about safety. Among the most serious side effects that can happen with Jakafi are those low blood counts I mentioned earlier. To help manage that risk, be sure to promptly get the blood tests your Healthcare Professional orders—so he or she can keep an eye on your blood counts and adjust your Jakafi dose as needed.

Onscreen text: Call your Healthcare Professional about:

  • Unusual bleeding
  • Bruising
  • Fatigue
  • Shortness of breath
  • Fever

Emily: You should also watch for symptoms of a low blood count, which include unusual bleeding or bruising, fatigue, shortness of breath, or a fever.

Onscreen text:Call your Healthcare Professional about:

  • Chills
  • Fever
  • Nausea or vomiting
  • Aches
  • Weakness
  • Skin rash with pain or blisters

Emily: Infection is another serious risk during Jakafi therapy. The symptoms of an infection to watch for are chills, fever, nausea or vomiting, aches, weakness, or a skin rash that becomes painful or blisters.

Emily: Be sure to contact your Transplant Team whenever you notice any symptoms like these or if you have questions or concerns about your medicine or your condition. Now, let’s review the Important Safety Information for Jakafi.

Onscreen text and narrator: 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.

Onscreen text: Please visit Jakafi.com to learn more.

Emily: Visit Jakafi.com to learn more about the possible risks and benefits of Jakafi for the treatment of acute GVHD for patients who have already taken corticosteroids and they did not work well enough.

Onscreen text: Learn more at IncyteCARES.com

Emily: If you’d like additional support while you’re taking Jakafi, ask your Healthcare Professional about enrolling you in IncyteCARES. Their call center can answer questions and connect you to helpful resources – like financial assistance, disease information, and more for eligible patients. You can learn more about this program at IncyteCARES.com.

Onscreen text: Please visit Jakafi.com to learn more.

This video is sponsored by Incyte Corporation.
Jakafi and the Jakafi logo are registered trademarks of Incyte.
© 2020, Incyte Corporation. MAT-JAK-03464  12/21

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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.