Myelofibrosis

What Effects Has Jakafi Shown in Clinical Trials?


Hematologist-oncologist Gary Grad, MD, explains the results of two clinical studies that explored whether Jakafi® (ruxolitinib) reduced enlarged spleens in people with intermediate or high-risk myelofibrosis (MF). ...more

Video Transcript

Onscreen text and narrator: In Clinical Trials, What Effects Has Jakafi® (ruxolitinib) Been Shown to Have in Patients With Intermediate- or High-Risk Myelofibrosis?

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.

Onscreen text: Jakafi (ruxolitinib) is a prescription medicine available as a pill

Dr Grad: Hi. I’m Dr Gary Grad, a hematologist-oncologist in private practice in the Chicago area. I treat patients with myelofibrosis, or MF, and other conditions in my practice.

Onscreen text and narrator: Jakafi is the first and only medicine approved by the Food and Drug Administration, or FDA, for the treatment of patients with certain types of myelofibrosis.

Jakafi is a prescription medicine available as a pill.

Dr Grad: Many patients with MF may have an enlarged spleen as well as symptoms related to their disease.

Onscreen text: Symptoms of an enlarged spleen:

  • Abdominal discomfort
  • Pain under the left ribs
  • Early feeling of fullness

Dr Grad: Spleen-related symptoms may include abdominal pain, pain under the left ribs, or early satiety, meaning that patients feel full soon after starting to eat.

Dr Grad: An enlarged spleen may also be a sign of progressive disease in MF. Therefore, it is important for your doctor to monitor your symptoms and your spleen size regularly, either by physical exam or imaging studies such as ultrasound, CT scan, or MRI.

Dr Grad: One of the goals of managing MF may be to reduce the size of the spleen if it is enlarged.

Dr Grad: In order to better understand how medicines may work and what side effects they may cause, researchers perform clinical trials, sometimes by comparing new treatments with existing treatments.

Onscreen text: Jakafi was studied in 2 clinical trials.

Dr Grad: Two clinical trials were conducted with Jakafi to evaluate the treatment of patients with certain types of MF.

Dr Grad: In one trial, Jakafi was compared with a placebo or sugar pill, and in the other Jakafi was compared with other treatments used for MF.

Onscreen text: In both clinical trials, Jakafi was better able to reduce spleen size.

Dr Grad: In both clinical trials, Jakafi was better able to reduce the size of the spleen. This was the main measure, or primary endpoint, of the study.

Onscreen text: Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered.

More information about this and other risks is presented later in this video.

Narrator: Jakafi (ruxolitinib) can cause low blood counts and may cause your platelet, red blood cell, or white blood cell counts to be lowered.

More information about this and other risks are presented later in this video.

Onscreen text: Symptoms included:

  • Abdominal discomfort
  • Pain under the left fibs
  • Early feeling of fullness
  • Itching
  • Night sweats
  • Bone/muscle pain

Dr Grad: In one trial, researchers found that Jakafi also reduced symptoms better than placebo.

Onscreen text: In people with intermediate or high-risk MF, Jakafi may help improve fatigue-related MF symptoms

Dr Grad: Patients may have symptoms directly related to MF, one of the most prominent of which is fatigue.

Dr Grad: In a separate analysis of the same trial, researchers specifically examined the symptom of fatigue and found that a higher percentage of patients with MF-related fatigue experienced improvement compared with patients given placebo.

Dr Grad: You can talk to your Healthcare Professional to learn more about the clinical trials with Jakafi and to better understand the results.

Dr Grad: If you have intermediate or high-risk MF, talk to your Healthcare Professional about whether Jakafi might 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: low platelet count, low red blood cell counts, bruising, dizziness, headache.

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, 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. Do not drink grapefruit juice while on Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.

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 www.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-00389   03/19

connect-patient

Connect With
a Patient
Like Dan

Connect With a
Patient Like Dan

Register for the Incyte Mentor Program and connect with another patient taking Jakafi.

Email Address

Continue Registering

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 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.