first and only prescription medicine approved by the FDA
Polycythemia Vera

How Do I Know if Hydroxyurea Is Not Right for Me?


Identifying HU intolerance

Hematologist-oncologist Gary Grad, MD, addresses the challenges that patients with polycythemia vera (PV) may experience when treated with a chemotherapy medicine called hydroxyurea. ...more

Video Transcript

Onscreen text and narrator: How Do I Know if Hydroxyurea Is Not Working Well Enough for Me or if I'm Intolerant to It?

Onscreen text and narrator: This video is intended for informational use only, and is not designed to replace the medical advice of your Healthcare Professional.

Onscreen text: Your Healthcare Professional is the best source for treatment-related questions and medical advice.

Dr Grad: Hi. I'm Dr Gary Grad, a hematologist-oncologist who specializes in the treatment of myeloproliferative neoplasms such as polycythemia vera, or PV.

Dr Grad: To understand if your treatment is working well enough, it is important to understand the goals of treatment in PV.

Onscreen text: Goals of therapy in patients with PV

  • Control blood counts
  • Relieve symptoms

Dr Grad: The goals of therapy are to optimally control blood counts, preferably without frequent phlebotomy, relieve disease-related symptoms, and to do so without significant side effects of therapy.

Onscreen text: Hydroxyurea (HU) may be appropriate for:

  • Patients who don't respond to initial therapy with low-dose aspirin and phlebotomy
  • Patients at higher risk
    • Age 60 or older
    • Previous history of blood clots

Dr Grad: Hydroxyurea is a drug used in patients with PV who are not responding optimally to treatment with phlebotomy and low-dose aspirin or who are at higher risk due to age or history of a blood clot.

Dr Grad: Not all patients respond adequately to hydroxyurea or are able to tolerate it, at the doses necessary to control their PV.

Onscreen text: Signs that HU may not be working well enough include:

  • Blood counts are still too high
  • The need for phlebotomy in addition to HU
  • It fails to reduce spleen enlargement

Dr Grad: You can tell hydroxyurea isn’t working well enough for you if your blood counts are not under optimal control,

Dr Grad: the need for phlebotomy in addition to HU

Dr Grad: …or, in cases of a very enlarged spleen, the spleen continues to be enlarged or cause symptoms, such as abdominal pain or an early feeling of fullness when eating.

Onscreen text: Signs of HU intolerance may include side effects such as:

  • Mouth sores
  • Leg ulcers
  • Nausea
  • Vomiting
  • Fever
  • Low blood counts

Dr Grad: In other cases, patients may not be able to continue treatment because of unacceptable side effects, such as mouth sores; leg ulcers; gastrointestinal side effects, such as nausea or vomiting; fevers; or too low of a white blood cell count or platelet count at the hydroxyurea dose needed.

Onscreen text: It's important to take an active role in your own care.

Onscreen text: Keep track of your blood counts and other aspects of your PV.

Dr Grad: You can track your response to hydroxyurea by tracking your blood counts and symptoms and discussing that information with your Healthcare Professional.

Onscreen text: Your Healthcare Professional can help you decide if Jakafi may be right for you.

Dr Grad: If it turns out hydroxyurea isn’t working well enough for you or if you have side effects from it that make you unable to take it, Jakafi may be an option.

Onscreen text and narrator: Jakafi® (ruxolitinib) is the first and only prescription medicine approved by the FDA to treat adults with PV who have already taken a medicine called hydroxyurea and it did not work well enough or they could not tolerate it. Important Safety Information is discussed later in this video.

Onscreen text: Only your Healthcare Professional can decide if Jakafi is right for you.

Dr Grad: Your healthcare professional can help you decide if Jakafi may be right for you.

Onscreen text and narrator: 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: for certain types of MF and PV – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

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, have high cholesterol or triglycerides, 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.

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: Register now for information, support, and resources. Visit Jakafi.com/Register

Onscreen text: This video is sponsored by Incyte Corporation. Jakafi and the Jakafi logo are registered trademarks of Incyte.
© 2020, Incyte Corporation. MAT-JAK-02309  07/20

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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.