Myelofibrosis, Spleen Size & You
Taking an active role in helping to manage your MF

Onscreen text: Myelofibrosis, Spleen Size & You: TAKING AN ACTIVE ROLE IN HELPING TO MANAGE YOUR MYELOFIBROSIS

Onscreen text and voiceover: This video is intended for informational use only and is not designed to replace the medical advice of your Healthcare Professional. Your Healthcare Professional is the best source for treatment-related questions and medical advice.

Onscreen text: Graphics are for illustrative purposes only.

Onscreen text: Myelofibrosis (MF) is a rare, chronic blood cancer that affects the bone marrow and the production of blood cells.

Voiceover: For people living with myelofibrosis (or MF), the spleen is an important health focus. This video provides helpful information about the role of the spleen and what every patient with MF should know about monitoring spleen size in MF.

Narrator: The spleen is an organ located near the stomach under your left rib cage.

Narrator: It has a number of important jobs, including helping the body filter the blood by removing old or damaged blood cells. Healthy red blood cells are able to pass back into circulation through small holes or slits in veins in the spleen, while old or damaged cells can’t, and are broken down. In addition, the spleen stores red blood cells and platelets.

Narrator: It also helps fight infection by producing white blood cells and fighting off invading disease-causing germs.

Narrator: Typically, the spleen is about the size of your fist.

Narrator: However, in people with MF, the spleen may become enlarged.

Onscreen text: An enlarged spleen is called splenomegaly (splee-nuh-MEG-uh-lee).

Narrator: The medical term for an enlarged spleen is called splenomegaly. And it’s a common finding in people with MF.

Onscreen text: IN ONE CLINICAL STUDY, ~90% of people with MF had an enlarged spleen at diagnosis

Narrator: In fact, in one clinical study, nearly 90% of people with MF had an enlarged spleen at the time of diagnosis. So, what causes the spleen to become enlarged in MF?

Onscreen text: 

• Red blood cells
• Platelets
• White blood cells

Narrator: Bone marrow is where blood cells are primarily made.

Narrator: In people with MF, scar tissue builds up in the bone marrow. As scar tissue builds up, the bone marrow can’t make enough normal blood cells. Red blood cell and platelet counts typically decrease over time, while white blood cell counts may increase or decrease.

Narrator: The spleen partially takes over blood cell production, and this may make the spleen get bigger. This is a common finding in people with MF.

Onscreen text: Why is spleen size an important health focus for people with MF?

Narrator: So, why is spleen size an important health focus for people with MF?

Narrator: First, as the spleen gets bigger in size, it can cause a variety of symptoms. Because the spleen is located in your abdominal area, an enlarged spleen may press on the stomach, making it difficult for the stomach to expand normally when eating.

Onscreen text:

• Early feeling of fullness (early satiety)
• Abdominal pain
• Discomfort under the left ribs

Be sure to share all of your symptoms with your Healthcare Professional, even if you’re not sure that they are related to your MF.

Narrator: For this reason, people with an enlarged spleen may feel full—even if they’ve eaten only a little bit of food. This early feeling of fullness is called early satiety. Enlargement of the spleen may also cause pain or discomfort in the abdominal area or below your left ribs. It’s important to share all of your symptoms with your Healthcare Professional, even if you’re not sure that they are related to your MF.

Narrator: But symptoms are not the only reason that patients with MF should be concerned about an enlarged spleen.

Onscreen text: MF is a progressive disease, which means that it can change or get worse over time.

Spleen enlargement may be a sign of disease progression in some people with MF.

Narrator: MF is a progressive disease, which means that it can change or get worse over time. In some people with MF, enlargement of the spleen may be a sign of disease progression.

Narrator: Early identification of an enlarged spleen is important and may help your Healthcare Professional to reassess your care management approach sooner if your MF is progressing. Remember, it’s important to work with your care team to regularly keep track of any changes in your spleen size or symptoms.

Onscreen text: Establish your baseline spleen size.

Narrator: Be sure to work with your Healthcare Professional to establish your “baseline” spleen size at diagnosis—or as early on in your treatment journey as possible.

Onscreen text: It’s important to have your spleen size checked on a regular basis.

Narrator: Because spleen enlargement is a common finding among people with MF, your Healthcare Professional can help you keep track of your spleen size by feeling or “palpating” your spleen on a regular basis.

Narrator: He or she can do this by gently feeling your left upper abdominal area, just below the left rib cage, to determine if there have been any changes in spleen size. Healthcare Professionals can feel for an enlarged spleen during a physical exam.

Onscreen text:

• CT Scan
• Ultrasound
• MRI

Narrator: However, depending on your body type, it can sometimes be difficult to accurately measure spleen size through physical exam alone. Your Healthcare Professional may order an imaging test, such as an ultrasound, CT scan or MRI, to provide a more accurate measure. He or she can help you document and keep track of spleen size by evaluating your spleen on a regular basis. Remember, early identification of any changes in your MF helps you and your Healthcare Professional have a more informed discussion.

Onscreen text: Keep track of any changes in your condition.

Narrator: Be sure to keep notes for yourself to document and keep track of any changes in your condition, such as increases or decreases in both MF symptoms and spleen size. Remember, regularly keeping track of your condition can help you and your Healthcare Professional identify possible changes over time. These insights can help ensure that your current MF management approach is the right one for you.

Onscreen text: Visit MFSpleenGuide.com to learn more.

Narrator: For additional information about spleen enlargement in MF, download a helpful guide at MFSpleenGuide.com.

Narrator: If you and your Healthcare Professional determine that your spleen size is enlarged, discover what may be possible with JAKAFI.

Onscreen text and Voiceover: JAKAFI or JAKAFI XR (ruxolitinib) is prescription medication used to treat adults with certain types of myelofibrosis (MF). It is not known if JAKAFI or JAKAFI XR is safe or effective in children for treatment of myelofibrosis.

Onscreen text and voiceover: Please see the Full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with JAKAFI or JAKAFI XR at Jakafi.com.

Onscreen text: 42% of people reached the set goal of reduction in the size of the spleen of at least 35%.
The efficacy and safety of JAKAFI XR is based on clinical trials using JAKAFI.

Narrator: JAKAFI may help reduce spleen size and spleen-related symptoms. The results of a key clinical trial in adults with intermediate or high-risk MF showed that after 6 months of treatment with JAKAFI: 42% of people reached the set goal of reduction in the size of the spleen of at least 35%. In contrast, less than 1% of people taking a placebo (sugar pill) reached that goal.

Onscreen text and narrator: JAKAFI has also been shown to help reduce spleen-related symptoms.

Onscreen text and narrator: How your MF may respond to JAKAFI depends on your specific circumstances. Individual results may vary. Talk to your Healthcare Professional to see if JAKAFI may be right for you.

Onscreen text: Learning to recognize the signs and symptoms of spleen enlargement can help you partner with your care team and take a more active role in your ongoing MF care.

Narrator: By understanding the connection between MF and your spleen, you can partner with your care team to help identify the signs and symptoms of spleen enlargement. And this can help you take a more active role in your ongoing MF care. Important Safety Information to follow.

Onscreen text and voiceover: Important Safety Information

What is JAKAFI^® or JAKAFI XR™?

JAKAFI or JAKAFI XR (ruxolitinib) is a prescription medication used to treat adults with certain types of myelofibrosis (MF).

It is not known if JAKAFI or JAKAFI XR is safe or effective in children for treatment of myelofibrosis.

Important Safety Information

JAKAFI^® or JAKAFI XR™ can cause serious side effects, including:

Low blood counts: JAKAFI^® or JAKAFI XR™ (ruxolitinib) may cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking JAKAFI or JAKAFI XR and call your healthcare provider. Your healthcare provider will do a blood test to check your blood counts before you start and regularly during your treatment. Your healthcare provider may change your dose 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
• a fever

Infection: You may be at risk for developing a serious infection during treatment with JAKAFI or JAKAFI XR. 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

Worsening of symptoms after interrupting or stopping treatment. Signs and symptoms of myelofibrosis may worsen after you stop treatment.
Do not interrupt or stop treatment without talking to your healthcare provider. Tell your healthcare provider right away if you have any of the following after stopping treatment:

• fever
• trouble breathing
• weakness
• night sweats
• feeling dizzy or lightheaded
• pain in left upper stomach area or left shoulder

Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will regularly check your skin during your treatment. Tell your healthcare provider if you develop any new or changing skin lesions during treatment.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking JAKAFI or JAKAFI XR 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 get any symptoms of a heart attack or stroke during treatment with JAKAFI or JAKAFI XR, 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 or JAKAFI XR, 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 or JAKAFI XR include:

• for certain types of myelofibrosis (MF) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea

These are not all the possible side effects. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

Before taking JAKAFI or JAKAFI XR, tell your healthcare provider about: 

• all the medications, vitamins, and herbal supplements you are taking
• your medical conditions, including if you
  • have or had low white or red blood cell counts
  • have an infection
  • 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 a high level of fat in your blood (high blood cholesterol or triglycerides)
  • have or have had a blood clot, heart attack, other heart problems, or stroke
  • are a current or past smoker
  • had cancer
  • have or had liver or kidney problems or are on dialysis. If you are on dialysis, JAKAFI or JAKAFI XR should be taken after your dialysis
  • have any other medical condition

Women should not take JAKAFI or JAKAFI XR while pregnant or planning to become pregnant. Do not breastfeed during treatment with JAKAFI or JAKAFI XR and for 2 weeks after the final dose.

How should I take JAKAFI or JAKAFI XR?

• Take exactly as your healthcare provider tells you.
• Do not change your dose or stop taking JAKAFI or JAKAFI XR without first talking to your healthcare provider. If you stop treatment, symptoms of your condition may return.
• If you miss a dose, take your next dose at your regular time. Do NOT take 2 doses at the same time.
• You may have regular blood tests during your treatment. Based on the results, your healthcare provider may change your dose or stop JAKAFI or JAKAFI XR.

• IF YOU ARE PRESCRIBED JAKAFI:
  • Take JAKAFI 2 times a day or exactly as your healthcare provider tells you, with or without food.
  • JAKAFI may also be given through certain nasogastric tubes.
  • Tell your healthcare provider if you cannot take JAKAFI by mouth. Your healthcare provider will decide if you can take JAKAFI through a nasogastric tube. Ask your healthcare provider to give you specific instructions on how to properly take JAKAFI through a nasogastric tube.
• IF YOU ARE PRESCRIBED JAKAFI XR:
  • Take JAKAFI XR 1 time a day with or without food.
  • Swallow JAKAFI XR whole. Do not split, crush, or chew.

Please see the Full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with JAKAFI or JAKAFI XR at Jakafi.com.

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 about JAKAFI or JAKAFI XR. Visit Jakafi.com/register-for-resources

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JAKAFI and the JAKAFI logo are registered trademarks of Incyte.   
JAKAFI XR and the JAKAFI XR logo are trademarks of Incyte.   
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