Sorry, you need to enable JavaScript to visit this website.

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 particular condition receive a medicine and researchers observe the results.

Jakafi® (ruxolitinib) 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
Photo of a couple looking out a window
 

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

Icon of a calendar

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

 

 
Icon of an arrow pointing down

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

Icon of 2 people

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


Graphic of a woman with a headset, sitting at a desk, in front of a computer

Already taking Jakafi? IncyteCARES for Jakafi is a patient support program helping eligible patients with access and support.

Learn More
Image of a healthcare professional

Hear From Incyte’s Experienced Nurse Educators.

In this video series, our team shares their insights on common acute GVHD questions and questions related to Jakafi.

View Videos
cgvhd

Looking for Chronic
Graft-Versus-Host Disease?
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

Expand
 
Collapse
 
 
 

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.