Is Jakafi Right for My Acute GVHD When Steroids Haven’t Worked Well Enough?


Taking Jakafi after steroids did not work well enough

Learn about factors that you and your Healthcare Professionals can discuss when considering treatment with Jakafi® (ruxolitinib).

Video Transcript

Onscreen text and narrator: Is Jakafi® (ruxolitinib) Right for My Acute GVHD When Steroids Haven't Worked Well Enough?

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.

Erin: Hi. I'm Erin Blackwell, an oncology clinical nurse educator for Incyte. For more than 8 years prior to coming to 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 acute GVHD.

Erin: Acute GVHD is a serious and sometimes life-threatening complication that can occur after a stem cell or bone marrow transplant.

Onscreen text: Corticosteroids—or steroids—are often the first treatment option for acute GVHD.

Erin: If acute GVHD does develop, the first treatment option is usually corticosteroids, also known as steroids. They are used to suppress the patient’s immune system.

Erin: Steroids may help to block or reduce the attack on the transplant patient’s organs from the donor immune cells.

Onscreen text: Approximately half of patients do not respond well enough to steroids.

Erin: Although steroid treatment is successful for some people with acute GVHD, approximately half of patients taking steroids do not respond initially or do not fully respond. That’s why it’s important to talk with your Transplant Team about any changes you may notice while you are being treated for acute GVHD.

Onscreen text: Patients who do not respond well enough to steroids are said to have steroid-refractory acute GVHD.

Erin: When patients don’t respond well enough to steroids—either because they didn’t have the desired response or because they required high doses that could not be reduced—they are said to have steroid-refractory acute GVHD.

Erin: Patients with steroid-refractory acute GVHD can be identified as early as 3 days after starting steroid treatment. That’s why it’s important to talk with your Transplant Team about any changes you may notice while you are being treated for acute GVHD.

Onscreen text and Erin: Healthcare Professionals may recommend or may suggest a different type of treatment for patients with steroid-refractory acute GVHD.

Erin: If you or a loved one has acute GVHD and it has not responded to therapy with steroids, you and your Transplant Team may discuss treatment with Jakafi.

Erin: Jakafi was studied in a clinical trial of patients with acute GVHD who were not responding well to steroids. Seventy-one patients were enrolled in the clinical trial for Jakafi. All patients were treated with Jakafi. Forty-nine patients who had not responded to steroid treatment alone (steroid-refractory acute GVHD) were evaluated to see how well treatment worked.

Onscreen text: 57% (28 of 49 patients) had a response with Jakafi at 1 month

Erin: In that trial, 57% of patients (28 of 49) who had not responded to steroid treatment alone had a response with Jakafi at 1 month.

Erin: 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 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: Your treatment journey depends on your individual circumstances and the decisions you make with your Transplant Team. Results may vary.

Erin: Talk to your Transplant Team to discover if Jakafi may be an option for you.

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

Erin: Be sure to talk with your Healthcare Professional or 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

Erin: 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-00547  03/20

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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 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, 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.