Possible Benefits of Jakafi®


Clinical trial with Jakafi

In order to better understand how medicines work and what side effects they may cause, researchers perform clinical trials in which patients with a disease often receive a medicine and researchers observe the results.

Jakafi was studied in a clinical trial in patients with acute graft-versus-host disease (GVHD) who had taken steroids and they did not work well enough.


Who was included in the clinical trial of Jakafi for acute GVHD?

71 patients with acute graft-versus-host disease (GVHD) who were not responding well to steroids with or without other medicines that suppress the immune system were enrolled in the clinical trial for Jakafi.

All patients were treated with Jakafi.

49 patients who had not responded to steroid treatment alone (steroid-refractory acute GVHD) were evaluated to see how well treatment worked.


What else should I know about these 49 patients?

  • Patients had moderate to severe acute GVHD with about 73% (36 patients) having severe disease
  • Acute GVHD affected at least 2 organs in about 55% (27 patients)
  • In addition to steroids, 96% (47 patients) were receiving other medications that suppress the immune system
  • Average age of patients was 57 years

How was response to Jakafi defined?

Response was measured at 1 month (the 28th day of treatment) and meant either:

  • Complete resolution of signs and symptoms of acute GVHD or
  • At least some improvement in skin, gastrointestinal tract, or liver signs and symptoms, without worsening or new symptoms in another organ

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Possible benefits of Jakafi

Image of 57% in a circle representing the number of patients who had a response at 1 month

28 of 49 patients who had not responded to steroid treatment alone had a response at 1 month

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About 68% of those who responded (19 of 28 patients) did so within 7 days

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In a separate evaluation:

About 47% of patients (14 of 30) who were still receiving both steroids and Jakafi at 1 month had their steroid dose reduced by 50% or more

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Your results with Jakafi may vary. Talk to your Transplant Team about any questions you have.

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Already taking Jakafi? IncyteCARES is a patient support program for people taking Jakafi that offers ongoing education and resources

If you and your Healthcare Professional decide that Jakafi is right for you, the registered nurses of IncyteCARES can help eligible patients understand their insurance coverage and financial assistance options, access possible travel cost assistance, plus provide ongoing education and support resources.

IncyteCARES: Connecting to Access, Reimbursement, Education and Support

Learn More
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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.