Onscreen text: Polycythemia Vera, Spleen Size & You: TAKING AN ACTIVE ROLE IN HELPING TO MANAGE YOUR POLYCYTHEMIA VERA
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: Polycythemia vera (PV) is a rare, chronic blood cancer in which a person’s body makes too many red blood cells, white blood cells, and platelets.
Voiceover: Polycythemia vera or PV is a rare, chronic blood cancer in which a person’s body makes too many red blood cells, white blood cells, and platelets. For people living with PV, the spleen is an important health focus. This video provides helpful information about the role of the spleen and what every patient with PV should know about monitoring spleen size in PV.
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 PV, 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.
Onscreen text: IN ONE CLINICAL STUDY, 36% (534 of 1477) of patients with PV had an enlarged spleen at the time of diagnosis.
Narrator: In one clinical study, 36% of patients with PV had an enlarged spleen at the time of diagnosis.
Onscreen text: Some patients with PV may experience spleen enlargement after living with the disease for a period of time.
Narrator: However, some patients with PV may experience spleen enlargement only after living with the disease for a period of time.
Onscreen text: What causes the spleen to become enlarged in PV?
Narrator: So what causes the spleen to become enlarged in PV?
Narrator: Blood cells are primarily made in the bone marrow.
Narrator: Patients with PV can often have too many blood cells, especially red blood cells (which can be measured by a lab test called hematocrit).
Narrator: As a result of the increased number of blood cells caused by PV, your spleen works harder than normal. This may cause the spleen to get bigger.
Onscreen text and narrator: Why is spleen size an important health focus for people with PV?
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 PV.
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 PV.
Onscreen text: PV is a progressive disease, which means that it can change or get worse over time.
Spleen enlargement may be a sign that your PV is changing.
Narrator: But spleen-related symptoms are not the only reason that patients with PV should be concerned about an enlarged spleen. PV is a progressive disease, which means that it can change or get worse over time. If your spleen becomes enlarged, it may be a sign your PV is changing.
Narrator: Early identification of an enlarged spleen is important and may help your Healthcare Professional to reassess your care management approach as needed.
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 PV journey as possible.
Onscreen text: It’s important to have your spleen size checked on a regular basis throughout your PV journey.
Narrator: Remember, it’s important to work with your care team to document and regularly keep track of any changes in your spleen size or symptoms.
Narrator: Your Healthcare Professional can help you keep track of your spleen size by feeling or “palpating” your spleen on a regular basis throughout your PV journey.
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.
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.
Onscreen text: Keep track of any changes in your condition.
Narrator: It’s also important to keep notes for yourself to monitor other ways that your PV may be changing over time. This may include changes in your blood counts, frequency of phlebotomies as well as any changes in your spleen size or spleen-related symptoms. Remember, early identification of any changes in your PV helps you and your Healthcare Professional have a more informed discussion. These insights can help ensure that your current PV management approach is the right one for you.
Onscreen text: Visit PVSpleenGuide.com to learn more.
Narrator: For additional information about spleen enlargement in PV, visit PVSpleenGuide.com.
Voiceover: If you have PV and have already taken a medicine called hydroxyurea (HU), ask your Healthcare Professional if Jakafi may be right for you.
Onscreen text and voiceover: Jakafi® (ruxolitinib) is the first FDA-approved prescription medicine for adults with PV who have already taken a medicine called hydroxyurea (HU) and it did not work well enough or they could not tolerate it.
Please see Important Safety Information included in this video and see Full Prescribing Informationfor Jakafi.
Onscreen text: 23% of patients taking Jakafi kept hematocrit under control and had a reduction in spleen size of at least 35% vs <1% in the group receiving other treatments.
Narrator: In a key clinical trial in adults with PV who did not benefit from treatment with HU or could not tolerate it, the results showed that after approximately 8 months of treatment 23% of patients in the group that received Jakafi reached the primary endpoint, or main goal, of keeping hematocrit under control and reducing spleen size by at least 35%.
This result was compared with <1% of patients in the group that received other treatments.
Onscreen text: 40% of patients receiving Jakafi had at least a 35% reduction in spleen size compared with 1% of patients receiving other treatments.
Narrator: When measured separately from hematocrit control, 40% of patients receiving Jakafi had at least a 35% reduction in their spleen size after approximately 8 months of treatment compared with <1% of patients receiving other treatments.
Onscreen text and voiceover: How your PV 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.
Narrator: 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 PV care.
Narrator: By understanding the connection between PV 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 PV care.
Important Safety Information to follow.
Onscreen text and voiceover: 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 at Jakafi.com, 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.
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Onscreen text: This video is sponsored by Incyte Corporation. Jakafi and the Jakafi logo are registered trademarks of Incyte.
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