Once-daily oral PROMACTA (eltrombopag) may increase platelet counts in children 1 year of age and older

Transcription

1 Once-daily oral PROMACTA (eltrombopag) may increase platelet counts in children 1 year of age and older Indications PROMACTA is a prescription medicine used to treat adults and children 1 year and older with low blood platelet counts due to chronic immune (idiopathic) thrombocytopenia (ITP) when other medicines to treat your ITP or surgery to remove the spleen have not worked well enough. PROMACTA is used to try to raise platelet counts in order to lower your risk for bleeding. PROMACTA is not used to make platelet counts normal. PROMACTA is for the treatment of certain people with low platelet counts caused by chronic ITP, chronic hepatitis C virus (HCV), or severe aplastic anemia (SAA), not for a precancerous condition called myelodysplastic syndromes (MDS) or low platelet counts caused by other conditions or diseases. Important Safety Information for PROMACTA (eltrombopag) What is the most important information I should know about PROMACTA? PROMACTA can cause serious side effects, including: Liver problems. If you have chronic hepatitis C virus and take PROMACTA with interferon and ribavirin treatment, PROMACTA may increase your risk of liver problems. Tell your health care provider right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of right upper stomach area (abdomen) pain the eyes (jaundice) confusion unusual darkening of the urine swelling of the stomach area unusual tiredness (abdomen) Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide.

2 This booklet is designed to help you better understand chronic ITP as well as available treatment options, including PROMACTA (eltrombopag). This booklet is also a resource to help support you in your important role as a caregiver to a child with chronic ITP. Chronic ITP varies from child to child and is diagnosed based on medical history, a physical exam, and blood test results. Table of contents What is chronic ITP? 3 Why are platelets important? 4 What is PROMACTA? 6 PROMACTA benefits and side effects 8 PROMACTA dosing 10 Dietary considerations for PROMACTA 12 Other considerations 14 Resources and support 17 Important Safety Information for PROMACTA 18 Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. 2

3 Caring for your child with chronic ITP What is chronic ITP? Chronic immune (idiopathic) thrombocytopenia (ITP) is a blood disorder in which there is an abnormal decrease in the number of platelets in the blood. Platelets are cells in the blood that help stop bleeding. A decrease in platelets can lead to bruising, bleeding gums, and internal bleeding. Chronic ITP is ITP that has lasted 6 months or longer and requires continual follow-up care with a doctor who specializes in blood diseases (hematologist) Idiopathic means that the cause is unknown Thrombocytopenia means a decreased number of platelets in the blood As a parent or caregiver of a child with chronic ITP, you might be well aware of the challenges associated with an unpredictable disease that can change from day to day. Chronic ITP can limit certain activities and affect how active your child can be. There are several treatment options available for chronic ITP, and your child may have tried one or more of them, including treatment with corticosteroids. If your child has chronic ITP, and has not had success with prior treatments, your child s doctor may recommend treatment with PROMACTA. In the following pages, you will find helpful information about PROMACTA. Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. 3

4 Why are platelets important? Platelets are cells that are made in the bone marrow and circulate in the blood Clot Blood vessel Platelet Platelets stick together to help form blood clots. Blood clots help prevent bleeding and bruising when your child gets a cut or wound. In a child with chronic ITP, there are not enough platelets, and blood clots do not form properly. When your child s platelet count is low, he or she may have bruising and/or bleeding that is hard to stop. What makes your child s platelet levels low? In chronic ITP, the way your child s body controls the number of platelets in circulation is out of balance. There are 3 ways that this can happen: 1 Platelets are destroyed. Your child s immune system thinks platelets are cells that will hurt the body, so it attacks them. 2 Platelets are trapped in the spleen. The spleen is an organ that removes old and damaged platelets and red blood cells from the blood circulation. Platelets that are attacked by the immune system are removed from the blood and trapped in the spleen. 3 Fewer platelets are made. In children with chronic ITP, there usually is not enough thrombopoietin (TPO) reaching the bone marrow. TPO is a protein produced primarily in the liver that controls how many platelets are made. This means that there are not enough platelets being made to replace destroyed platelets. Platelets destroyed Platelets trapped in spleen Circulating platelets Please see Important Safety Information for PROMACTA on pages

5 A number of treatment options are available to help restore normal platelet counts in patients with chronic ITP Immunosuppressants Immunosuppressants are agents that slow down the immune system. Medications like corticosteroids and intravenous immunoglobulin (IVIG) are immunosuppressants that decrease the number of platelets being destroyed. Splenectomy Splenectomy is the surgical removal of the spleen. In chronic ITP, platelets are removed from the blood and trapped in the spleen. By removing the spleen, more platelets remain in the blood circulation. TPO-receptor agonists Thrombopoietin receptor agonists, or TPO-receptor agonists for short, are medicines that work by sending signals to the body to make more platelets. Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. 5

6 What is PROMACTA (eltrombopag)? PROMACTA may increase platelet counts in children 1 year of age and older PROMACTA is the first and only approved TPO-receptor agonist for managing pediatric and adult chronic ITP. PROMACTA is a prescription medicine used to treat adults and children 1 year and older with low blood platelet counts due to chronic immune (idiopathic) thrombocytopenia (ITP) when other medicines to treat your child s ITP or surgery to remove the spleen have not worked well enough. PROMACTA is also used to treat patients with: Low blood platelet counts due to chronic hepatitis C virus (HCV) infection before and during treatment with interferon Severe aplastic anemia (SAA) when other medicines to treat SAA have not worked well enough PROMACTA is used to try to raise platelet counts in order to lower your child s risk of bleeding. PROMACTA is not used to make platelet counts normal. PROMACTA is for the treatment of certain people with low platelet counts caused by chronic ITP, chronic HCV, or SAA, not for a precancerous condition called myelodysplastic syndromes (MDS) or low platelet counts caused by other conditions or diseases. PROMACTA has been approved by the Food and Drug Administration for patients aged 1 year and older with chronic ITP. Important Safety Information for PROMACTA (eltrombopag) What are the possible side effects of PROMACTA? PROMACTA may cause serious side effects, including: Worsening of a precancerous blood condition to a blood cancer called acute myelogenous leukemia (AML). PROMACTA is not for treatment of people with a precancerous condition called myelodysplastic syndromes (MDS). If you have MDS and receive PROMACTA, your MDS condition may worsen and become AML. If MDS worsens to become AML, you may die sooner from AML Abnormal liver function tests. Your health care provider will order blood tests to check your liver before you start taking PROMACTA and during your treatment. In some cases, treatment with PROMACTA may need to be stopped due to changes in your liver function tests 6 Please see Important Safety Information for PROMACTA on pages

7 It is not known if PROMACTA is safe and effective when used with other antiviral medicines that are approved to treat chronic hepatitis C. It is not known if PROMACTA is safe and effective in children with chronic hepatitis C or severe aplastic anemia, or in children younger than 1 year of age with ITP. High platelet counts and higher risk for blood clots. Your risk of getting a blood clot is increased if your platelet count is too high during treatment with PROMACTA. Your risk of getting a blood clot may also be increased during treatment with PROMACTA if you have normal or low platelet counts. You may have severe problems or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your health care provider will check your blood platelet counts and change your dose or stop PROMACTA if your platelet counts get too high. Tell your health care provider right away if you have signs and symptoms of a blood clot in the leg such as swelling, pain, or tenderness. People with chronic liver disease may be at risk for a type of blood clot in the stomach area. Tell your health care provider right away if you have stomach area pain that may be a symptom of this type of blood clot New or worsened cataracts (a clouding of the lens in the eye). New or worsened cataracts have happened in people taking PROMACTA. Your health care provider will check your eyes before and during your treatment with PROMACTA. Tell your health care provider about any changes in your eyesight while taking PROMACTA Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. 7

8 How PROMACTA (eltrombopag) may help your child If your child has been diagnosed with chronic ITP, and other treatments have not worked well enough, the doctor may recommend PROMACTA. PROMACTA is a once-daily oral medicine that helps to boost your child s platelet counts and keep them higher than before treatment. The safety and benefits of taking PROMACTA for children aged 1 to 17 years with chronic ITP were evaluated across 2 clinical studies. In 2 clinical studies, one lasting 7 weeks and the other lasting 13 weeks, when pediatric patients received PROMACTA PROMACTA helped increase platelet counts to target levels* PROMACTA helped maintain target platelet levels over the course of 13 weeks in the second study Platelet levels started to increase within 1 to 2 weeks after starting PROMACTA and decreased within 1 to 2 weeks after stopping PROMACTA In the 2 studies, 46% (6/13) and 53% (8/15) of patients, respectively, who were treated with PROMACTA and were also receiving other ITP therapy were able to reduce or discontinue their other medications for chronic ITP (mainly corticosteroids). * Target levels: platelet counts equal to or greater than 50,000/mcL achieved at least once between Week 1 and Week 6 of the study. Maintained target levels: platelet counts equal to or greater than 50,000/mcL for at least 6 of 8 weeks. 8 Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide.

9 Safety and side effects of PROMACTA In the clinical trials, the most common side effects of PROMACTA when used in children were: Upper respiratory tract infection. Symptoms may include runny nose, stuffy nose, and sneezing (rhinitis) Pain or swelling (inflammation) in your child s nose, throat, or mouth (oropharyngeal pain and pharyngitis/nasopharyngitis) Cough Diarrhea Fever Stomach (abdominal) pain Mouth or throat pain Toothache Abnormal liver function tests Rash PROMACTA may cause serious side effects, including: Worsening of a precancerous blood condition to a blood cancer called acute myelogenous leukemia (AML). PROMACTA is not for treatment of people with a precancerous condition called myelodysplastic syndromes (MDS). If you have MDS and receive PROMACTA, your MDS condition may worsen and become AML. If MDS worsens to become AML, you may die sooner from AML Abnormal liver function tests. Your health care provider will order blood tests to check your liver before you start taking PROMACTA and during your treatment. In some cases, treatment with PROMACTA may need to be stopped due to changes in your liver function tests High platelet counts and higher risk for blood clots. Your risk of getting a blood clot is increased if your platelet count is too high during treatment with PROMACTA. Your risk of getting a blood clot may also be increased during treatment with PROMACTA if you have normal or low platelet counts. You may have severe problems or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your health care provider will check your blood platelet counts and change your dose or stop PROMACTA if your platelet counts get too high. Tell your health care provider right away if you have signs and symptoms of a blood clot in the leg such as swelling, pain, or tenderness. People with chronic liver disease may be at risk for a type of blood clot in the stomach area. Tell your health care provider right away if you have stomach area pain that may be a symptom of this type of blood clot New or worsened cataracts (a clouding of the lens in the eye). New or worsened cataracts have happened in people taking PROMACTA. Your health care provider will check your eyes before and during your treatment with PROMACTA. Tell your health care provider about any changes in your eyesight while taking PROMACTA Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. 9

10 Once-daily dosing for patients 1 year and older with chronic ITP Your child can take PROMACTA (eltrombopag) at home or on the go PROMACTA tablets are available in 4 strengths Once-daily tablets 12.5 mg 25 mg 50 mg 75 mg Tablets not actual size. Store PROMACTA at room temperature between 68 F and 77 F 10 Please see Important Safety Information for PROMACTA on pages

11 How and when your child should take PROMACTA Be sure your child takes PROMACTA exactly as instructed by the doctor Your child s doctor may adjust the dose of PROMACTA to your child s individual needs Your child should not stop taking PROMACTA without you discussing it with his or her doctor first Do not change your child s dosage or schedule for taking PROMACTA unless his or her doctor tells you to change it If your child misses a dose of PROMACTA, he or she should wait and take the next scheduled dose. Your child should not take more than 1 dose of PROMACTA in 1 day If your child takes too much PROMACTA, he or she may be at a higher risk of serious side effects. Call your child s doctor right away Tell your child s doctor about any bruising or bleeding that happens while your child is taking PROMACTA and after he or she stops taking it Please see Important Safety Information for PROMACTA on pages

12 How your child should take PROMACTA (eltrombopag) PROMACTA should be taken on an empty stomach Your child should take PROMACTA at least 1 hour before or 2 hours after eating. Below are examples of foods your child may eat. These are just examples be sure to talk with your doctor about your child s meal plan. If your child has already taken PROMACTA, wait at least 1 hour before eating these foods. If your child has already eaten, wait at least 2 hours to take PROMACTA. Dairy-free, low-calcium foods* Fruits such as apples, cherries, bananas, berries, watermelon, and grapes Nonleafy vegetables such as carrots, cucumbers, corn, tomatoes, potatoes, and mushrooms Certain types of nuts such as pine nuts, and peanut butter Eggs, and meats and poultry such as bacon, hot dogs, beef, pork, chicken, salami, corned beef, sausage, ham, and turkey Certain types of fish such as swordfish, flounder, and bass Snacks such as bagels, popcorn, pretzels, and raisins Desserts such as gelatin, cookies, and angel food cake Example snack: A cup of sliced apples dipped in peanut butter (1 tablespoon). Approximate total calcium content: 20 mg. * All foods listed above have less than or equal to 50 mg of calcium. Food allergies should be a consideration with any change in diet. Make sure that your child s total meal contains less than 50 mg of calcium if your child plans to take or has taken PROMACTA within the 1- to 2-hour time frame. A good resource for checking the calcium content of hundreds of foods is the National Nutrient Database: ndb.nal.usda.gov/ndb/foods. 12 Please see Important Safety Information for PROMACTA on pages

13 PROMACTA cannot be taken with calcium-rich foods and supplements Your child should take PROMACTA at least 2 hours before or 4 hours after taking other medications, calcium-rich foods, and certain supplements. These can change how much of PROMACTA your child s body absorbs. Calcium-rich foods and supplements include : Dairy products such as frozen and unfrozen yogurt, buttermilk, cheese, pudding, milk, and ice cream Calcium-rich and fortified foods (those with added calcium) such as some types of oatmeal, orange juice, dry cereal, and bread Some types of seafood such as clams or trout Leafy green vegetables such as collard greens and spinach Tofu or other soy products Antacids used to treat stomach ulcers or heartburn; vitamins; or supplements such as iron, calcium, aluminum, magnesium, selenium, or zinc. Talk with your doctor before allowing your child to take any over-the-counter medications, herbs, or supplements Note: many dairy alternatives, such as almond or rice milk, may still contain calcium. Make sure to check these products before consuming. All foods listed above have more than 50 mg of calcium. To help you remember how and when to take PROMACTA, follow the before-or-after rule: PROMACTA should be taken at least 1 hour before or 2 hours after a meal PROMACTA should be taken at least 2 hours before or 4 hours after consuming more than 50 mg of calcium This includes calcium-rich foods, other medications (such as antacids), or supplements. You may find it convenient to have your child take PROMACTA at bedtime. Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. 13

14 Other considerations for PROMACTA (eltrombopag) Monitoring platelet counts Platelet counts in children taking PROMACTA are monitored every week at first, while the dose is being adjusted Once the doctor decides your child s dose can stay the same, your child s platelet count will be checked once a month After stopping PROMACTA, your child s platelet count needs to be monitored twice weekly for at least 4 weeks to check if it drops too low Your child s doctor will order blood tests to check your child s liver before your child starts taking PROMACTA and during his/her treatment In some cases, treatment with PROMACTA may need to be stopped due to changes in your child s liver function tests The doctor will check your child s eyes before and during his/her treatment with PROMACTA. Tell the doctor about any changes in your child s eyesight while taking PROMACTA 14 Please see Important Safety Information for PROMACTA on pages

15 Why doctors may recommend PROMACTA If your child has been diagnosed with chronic ITP and if corticosteroids, IVIGs, or a splenectomy haven t worked well enough, his or her doctor may recommend PROMACTA. PROMACTA helps to boost your child s platelet counts and keep them higher than before treatment PROMACTA has also been studied in pediatric patients who have low platelet counts (less than 30,000/mcL) and for whom corticosteroids, IVIGs, or splenectomy haven t worked well enough In 2 clinical studies, some patients treated with PROMACTA were able to stop other medicines like corticosteroids or IVIGs PROMACTA is a once-daily medicine that your child can take at home or on the go. Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. 15

16 What should you tell the doctor before your child takes PROMACTA (eltrombopag)? Tell your doctor if your child: Yes No Has liver or kidney problems Has a precancerous condition called MDS or a blood cancer Has a history of cataracts Has or has had a blood clot Has had surgery to remove his or her spleen (splenectomy) Has bleeding problems Is of East Asian ancestry, such as Chinese, Japanese, Taiwanese, or Korean (a lower dose of PROMACTA may be needed) Has any other medical conditions Is pregnant or plans to become pregnant. It is not known if PROMACTA will harm an unborn baby Is breastfeeding or plans to breastfeed. It is not known if PROMACTA passes into breast milk. You and your child s doctor should decide whether your child will take PROMACTA or breastfeed. She should not do both Tell your child s doctor about all the medicines he or she takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PROMACTA may affect the way certain medicines work. Certain other medicines may affect the way PROMACTA works. Tell your child s doctor if he or she takes certain medicines called statins (used to treat high cholesterol) or a blood thinner medicine. Call your child s doctor to report any bleeding or bruising. 16 Please see Important Safety Information for PROMACTA on pages

17 Resources and support available while your child is taking PROMACTA This website is a source of comprehensive information relating to PROMACTA. PROMACTA Meal Planner The PROMACTA Meal Planner is a brochure available to you from the doctor s office. It contains information about dietary restrictions and can help you plan when your child should take PROMACTA. This informational brochure is also available as a PDF download at Please see Important Safety Information for PROMACTA on pages

18 Important Safety Information for PROMACTA (eltrombopag) What is the most important information I should know about PROMACTA? PROMACTA can cause serious side effects, including: Liver problems. If you have chronic hepatitis C virus and take PROMACTA with interferon and ribavirin treatment, PROMACTA may increase your risk of liver problems. Tell your health care provider right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice) unusual darkening of the urine unusual tiredness right upper stomach area (abdomen) pain confusion swelling of the stomach area (abdomen) What are the possible side effects of PROMACTA? PROMACTA may cause serious side effects, including: Worsening of a precancerous blood condition to a blood cancer called acute myelogenous leukemia (AML). PROMACTA is not for treatment of people with a precancerous condition called myelodysplastic syndromes (MDS). If you have MDS and receive PROMACTA, your MDS condition may worsen and become AML. If MDS worsens to become AML, you may die sooner from AML Abnormal liver function tests. Your health care provider will order blood tests to check your liver before you start taking PROMACTA and during your treatment. In some cases, treatment with PROMACTA may need to be stopped due to changes in your liver function tests High platelet counts and higher risk for blood clots. Your risk of getting a blood clot is increased if your platelet count is too high during treatment with PROMACTA. Your risk of getting a blood clot may also be increased during treatment with PROMACTA if you have normal or low platelet counts. You may have severe problems or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your health care provider will check your blood platelet counts and change your dose or stop PROMACTA if your platelet counts get too high. Tell your health care provider right away if you have signs and symptoms of a blood clot in the leg such as swelling, pain, or tenderness. 18 Please see additional Important Safety Information for PROMACTA on pages

19 Important Safety Information for PROMACTA (eltrombopag) (cont) People with chronic liver disease may be at risk for a type of blood clot in the stomach area. Tell your health care provider right away if you have stomach area pain that may be a symptom of this type of blood clot New or worsened cataracts (a clouding of the lens in the eye). New or worsened cataracts have happened in people taking PROMACTA. Your health care provider will check your eyes before and during your treatment with PROMACTA. Tell your health care provider about any changes in your eyesight while taking PROMACTA What should I tell my health care provider before taking PROMACTA? Before you take PROMACTA, tell your health care provider about all of your medical conditions, including if you: have liver or kidney problems have a precancerous condition called MDS or a blood cancer have or have had a blood clot have a history of cataracts have had surgery to remove your spleen (splenectomy) have bleeding problems are Asian and have Chinese, Japanese, Taiwanese, or Korean ancestry. You may need a lower dose of PROMACTA are pregnant or plan to become pregnant. It is not known if PROMACTA will harm an unborn baby are breastfeeding or plan to breastfeed. It is not known if PROMACTA passes into your breast milk. You and your health care provider should decide whether you will take PROMACTA or breastfeed. You should not do both Please see additional Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information for PROMACTA, including Boxed WARNING, and Medication Guide. 19

20 Important Safety Information for PROMACTA (eltrombopag) (cont) Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PROMACTA may affect the way certain medicines work. Certain other medicines may affect the way PROMACTA works. Especially tell your health care provider if you take: certain medicines used to treat high cholesterol, called statins a blood thinner medicine Certain medicines may keep PROMACTA from working correctly. Take PROMACTA at least 2 hours before or 4 hours after taking these products: antacids used to treat stomach ulcers or heartburn multivitamins or products that contain iron, calcium, aluminum, magnesium, selenium, and zinc, which may be found in mineral supplements Ask your health care provider if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of them and show it to your health care provider and pharmacist when you get a new medicine. What should I avoid while taking PROMACTA? Avoid situations and medicines that may increase your risk of bleeding. The most common side effects of PROMACTA in adults when used to treat chronic ITP are: nausea diarrhea upper respiratory tract infection (symptoms may include runny nose, stuffy nose, and sneezing) vomiting muscle aches urinary tract infection (symptoms may include frequent or urgent need to urinate, low fever in some people, pain or burning with urination) pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain and pharyngitis) abnormal liver function tests back pain flu-like symptoms including fever, headache, tiredness, cough, sore throat, and body aches skin tingling, itching, or burning rash Please see additional Important Safety Information for PROMACTA on pages

21 Important Safety Information for PROMACTA (eltrombopag) (cont) The most common side effects of PROMACTA in children 1 year and older when used to treat chronic ITP are: upper respiratory tract infection (symptoms may include runny nose, stuffy nose, and sneezing) pain or swelling (inflammation) in your nose or throat (nasopharyngitis) cough diarrhea fever runny, stuffy nose (rhinitis) stomach (abdominal) pain pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain) toothache rash abnormal liver function tests Laboratory tests may show abnormal changes to the cells in your bone marrow. Tell your health care provider about any bruising or bleeding that happens while you take, and after you stop taking, PROMACTA. Tell your health care provider if you have any side effect that bothers you or does not go away. If you take too much PROMACTA, you may have a higher risk of serious side effects. Call your health care provider right away. These are not all the possible side effects of PROMACTA. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at FDA Keep PROMACTA and all medicines out of the reach of children. Please see additional Important Safety Information for PROMACTA on page

22 Important Safety Information for PROMACTA (eltrombopag) (cont) General information about the safe and effective use of PROMACTA Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use PROMACTA for a condition for which it was not prescribed. Do not give PROMACTA to other people even if they have the same symptoms that you have. It may harm them. This is a summary of the most important information about PROMACTA. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about PROMACTA that is written for health professionals. For more information about PROMACTA, go to or call You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA

23 ss To learn more about chronic ITP and PROMACTA (eltrombopag), please visit Indications PROMACTA is a prescription medicine used to treat adults and children 1 year and older with low blood platelet counts due to chronic immune (idiopathic) thrombocytopenia (ITP) when other medicines to treat your ITP or surgery to remove the spleen have not worked well enough. PROMACTA is used to try to raise platelet counts in order to lower your risk for bleeding. PROMACTA is not used to make platelet counts normal. PROMACTA is for the treatment of certain people with low platelet counts caused by chronic ITP, chronic hepatitis C virus (HCV), or severe aplastic anemia (SAA), not for a precancerous condition called myelodysplastic syndromes (MDS) or low platelet counts caused by other conditions or diseases. Important Safety Information for PROMACTA (eltrombopag) What is the most important information I should know about PROMACTA? PROMACTA can cause serious side effects, including: Liver problems. If you have chronic hepatitis C virus and take PROMACTA with interferon and ribavirin treatment, PROMACTA may increase your risk of liver problems. Tell your health care provider right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice) unusual darkening of the urine unusual tiredness right upper stomach area (abdomen) pain confusion swelling of the stomach area (abdomen) Please see additional Important Safety Information for PROMACTA on pages Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis 10/17 PRM