Myelofibrosis

What Are the Common Side Effects of Jakafi?


Understanding possible common side effects associated with Jakafi

In this video, hematologist-oncologist Gary Grad, MD, talks about the most common side effects of a prescription medicine called Jakafi® (ruxolitinib). ...more

Video Transcript

Onscreen text: What Are the Most Common Side Effects of Jakafi 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 and for Adults With Certain Types of Myelofibrosis?

Narrator: What Are the Most Common Side Effects of Jakafi® (ruxolitinib) and What Should I Report to My Healthcare Professional When Taking 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, and myelofibrosis, or MF.

Onscreen text and Dr Grad: Jakafi® (ruxolitinib) is a prescription medicine available as a pill.

Onscreen text: Important Safety Information is discussed later in this video.

Onscreen text and Dr Grad: Jakafi® (ruxolitinib) is the first and only FDA-approved 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 also used to treat adults with certain types of myelofibrosis.

Dr Grad: Jakafi can have side effects. The most common side effects with Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, and headache.

Onscreen text: Your Healthcare Professional will regularly monitor your blood counts

Dr Grad: Your Healthcare Professional will regularly monitor your blood counts and may change your dose of Jakafi or stop your treatment based on the results of your blood tests

Dr Grad: Also, because Jakafi affects the production of blood cells, patients taking Jakafi may be at risk for developing serious infections.

Additional risks associated with Jakafi include certain types of non-melanoma skin cancers and increases in blood cholesterol levels.

Dr Grad: Some other medications that you may be taking or changes in your kidney or liver function might affect dosing of Jakafi.

Dr Grad: You should make your Healthcare Professional aware of any changes in your health status, any new medications or any changes in medications that you may already be taking

Onscreen text: It is important that you continue to take Jakafi exactly as prescribed.

Dr Grad: You should take Jakafi exactly as your healthcare professional tells you.

Onscreen text and Dr Grad: Do not change your dose or stop taking Jakafi without first talking to your Healthcare Professional.

Onscreen text: Grapefruit juice can affect the amount of Jakafi in your blood.

Dr Grad: Do not drink grapefruit juice while on Jakafi.

Onscreen text: Tell your Healthcare Professional if you develop any of the following symptoms of infection:

  • Chills
  • Fever
  • Nausea
  • Vomiting
  • Aches
  • Weakness
  • Painful skin rash or blisters

Dr Grad: You can help your Healthcare Professional by tracking your blood counts and by telling your Healthcare Professional if you develop any of the following symptoms of infection: chills, fever, nausea, vomiting, aches, weakness, painful skin rash or blisters.

Onscreen text: Tell your Healthcare Professional if you develop any of the following:

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

Dr Grad: 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.

Onscreen text and Dr Grad: For more information about the possible side effects of Jakafi, be sure to speak with your Healthcare Professional.

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, and headache; 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.
© 2019, Incyte Corporation. MAT-JAK-01081   08/19

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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 also 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.

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, and headache; 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.