I M UP FOR THE COUNT WITH MY ONCE-DAILY TABLET. INDICATION FOR PROMACTA (eltrombopag) IMPORTANT SAFETY INFORMATION FOR PROMACTA (eltrombopag)

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1 INDICATION FOR PROMACTA (eltrombopag) 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. 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) I M UP FOR THE COUNT WITH MY ONCE-DAILY TABLET Please see Important Safety Information for PROMACTA on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.

2 PROMACTA is a once-daily drug that helps you with your chronic ITP (citp). Your doctor may consider PROMACTA if other treatments such as corticosteroids haven t worked well enough for you. One tablet a day can help raise platelet counts, and keep them at safe and stable levels.* What is PROMACTA? Side effects Taking PROMACTA Patient Support Program Questions for your doctor Financial assistance Tracking your progress *The results seen with PROMACTA were similar among patients who either: Were taking other medications to treat their chronic ITP in addition to PROMACTA Had their spleen removed Had various platelet count levels when they started PROMACTA Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 2

3 UP next: my PROMACTA journal 3

4 She said with my platelets still low after my first course of treatment, a different medicine could help. Fingers crossed! PROMACTA is a once-daily tablet that may raise platelet levels in patients with chronic ITP.* In clinical studies of adults with chronic ITP, PROMACTA increased and maintained platelet counts within the target range* defined by each study. Platelet counts increased as early as 1 to 2 weeks after starting treatment and decreased within 1 to 2 weeks after stopping treatment. * Target range defined as platelet counts of billion per liter ( x 10 9 L) during the 6-month period that patients received PROMACTA or placebo. Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 4

5 My doctor explained to me how it works PROMACTA may increase platelet counts. Platelets are produced in your bone marrow, and they help your body stop bleeding when you get a bruise or cut. Chronic ITP is a condition lasting 6 months or longer in which your body does not have enough blood cell fragments, called platelets, in the blood. PROMACTA may increase platelet production in your body. And it s all in a once-daily tablet. My doctor told me that clinical studies showed PROMACTA working to raise platelet counts for a majority of patients. 5

6 Always keep an eye on how your body reacts to new medication. Contact your doctor if your chronic ITP symptoms don t seem to be improving, and tell your doctor about any bruising or bleeding that happens while you take, and after you stop taking, PROMACTA. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA

7 PROMACTA can cause serious side effects, including: Liver problems Abnormal liver function tests In clinical trials, the most common side effects of PROMACTA for adult chronic ITP were: 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 High platelet counts and higher risk for blood clots New or worsened cataracts Pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain and pharyngitis) Abnormal liver function tests Back pain Flu-like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches Skin tingling, itching, or burning Rash Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 7

8 Your doctor will prescribe the right dose for you. PROMACTA tablets are taken once-daily and are available in 4 strengths mg Tablets not actual size. 25 mg 50 mg 75 mg I m making PROMACTA part of my daily routine. The mealtime considerations are important and help PROMACTA work properly. When you take PROMACTA, there s a before-or-after rule you should always keep in mind. See this guideline: Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. I take PROMACTA at least 1 hour before or 2 hours after a meal. When I have more than 50 mg of calcium: I take PROMACTA at least 2 hours before or 4 hours after. 8

9 Here are some examples of foods that have more than 50 mg of calcium: Dairy products (yogurt, cheese, milk, ice cream) Calcium-fortified foods (orange juice, dry cereal, bread) Leafy green vegetables (collard greens, spinach) Check the labels of any food or supplement to be sure. Note the serving size. If you eat more, you re also getting more calcium. Nutrition Facts Serv. Size 4 cookies (32g) Servings per Container 9 Calories 150 Calories from fat 60 Amount/Serving %DV* Amount/Serving %DV* Total Fat 7g 11% Total Carb 20g 7% Sat. Fat 4.5g 23% Dietary Fiber 1g 4% Trans Fat 0g Sugars 10g Cholest. 0mg 0% Protein 2mg Sodium 115mg 5% Vitamin A 5% Vitamin C 3% Calcium 1% Iron 4% INGREDIENTS: Enriched Flour (Wheat Flour, Niacin, Reduced Iron, Vitamin B1, Vitamin B2, Folic Acid), Sugar, Vegetable Oil, Whey, Dextrin, Corn Syrup, Cornstarch, Salt, Baking Soda, Molasses, Natural and Artificial Flavors, Eggs. To be considered low-calcium, a food should contain 5% or less of the recommended daily value, or approximately 50 mg. If you eat more than 1 low-calcium food, make sure you pay attention to the combined total. Besides being in milk, cream, butter, and cheese, calcium can also be found in casein and whey. 9

10 I can fit PROMACTA into my busy life You must take your PROMACTA every day to ensure that it works. Reach out to your doctor with any questions about dose, side effects, and length of therapy. 10

11 Talk to your doctor about what may work best for you. Here s an example for a 9 pm bedtime, but you can work PROMACTA into your own daily meal routine. I don t eat any dairy-rich products after 5:00 PM I don t eat any food after 7:00 PM I got the PROMACTA Meal Planner today from my doctor. It offers tips and examples to help me manage my new routine! You can always download a copy from our site at up-for-promacta.com. Be sure to use the treatment journal at the end of this brochure to help you and your doctor monitor your treatment progress. I take PROMACTA at 9:00 PM Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 11

12 THE PROMACTA PATIENT SUPPORT PROGRAM Information and resources designed for you. Taking medicine is an important part of managing your condition. But getting the right support and resources may help you stay on track. Created with your needs in mind, the PROMACTA Patient Support Program includes s, online activities, and printable materials designed to assist you with your PROMACTA prescription. Learn more about: Living with chronic ITP Finding a dosing schedule that works for you Communicating with your health care team Ways to help manage the emotional impact of chronic ITP Once your enrollment is complete, you will begin receiving information from the PROMACTA Patient Support Program. Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 12

13 Ways to enroll in the PROMACTA Patient Support Program Visit promacta-patientsupport.com Call PROMACTA ( ) Ask your doctor for an enrollment form 13

14 You may have many questions about chronic ITP and PROMACTA before or after you start treatment. The more you know, the better prepared you ll be for your treatment. Here are some questions you could ask your doctor before treatment: How will chronic ITP continue to affect my life? What are all my treatment options? Which treatment do you recommend for me now? Why? What can I expect from treatment? Will I have to take more than 1 medication to continue treating my condition? Here are some questions about PROMACTA: How and when should I take PROMACTA? How long will I have to take PROMACTA? How will I know if my treatment is working? What drugs or supplements may affect PROMACTA? What are the possible side effects of PROMACTA? What special precautions should I follow? What should I do if I miss a dose? How often will I have blood tests? When should I contact you immediately? What should I do in case of emergency or overdose? How should I store PROMACTA tablets? What else do you think is important for me to know about PROMACTA? 14

15 PROMACTA OFFERS FINANCIAL SUPPORT THROUGH THE UNIVERSAL CO-PAY CARD AND PATIENT ASSISTANCE NOW ONCOLOGY Universal Co-pay Card Save on your out-of-pocket costs To find out if you are eligible, call , or visit You may be eligible for immediate co-pay savings on your next prescription: Pay no more than $25 per month out of pocket Easy sign-up, no additional fees Available to most patients with commercial insurance Covers up to $15,000 per calendar year To find out if you are eligible to save on your next prescription, call or visit Limitations apply. See program terms and conditions. Terms and Conditions This offer is valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash-paying patients, where product is not covered by patient s commercial insurance, or where plan reimburses you for entire cost of your prescription drug. Offer is not valid where prohibited by law. Valid only in the United States and Puerto Rico. This program is not health insurance. Offer may not be combined with any other rebate, coupon or offer. The card is property of Novartis Pharmaceuticals Corporation and must be returned upon request. Novartis reserves the right to rescind, revoke, or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer. This offer expires on December 31, Patient Instructions Patients with commercial insurance will be responsible for up to $25 and the program pays the remaining copay or coinsurance until you reach the yearly maximum or $15, After the program maximum, you will be responsible for the difference. Questions should be directed to: When you use this offer you are certifying that you understand the program rules, regulations, and terms and conditions and that you will disclose and report the use of this offer as may be required by your insurer. You are not eligible if prescriptions are paid by any federal or state program, or where prohibited by law; and you will otherwise comply with the terms and conditions above. Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 15

16 Novartis Oncology is committed to helping patients receive the medicines they need. Patient Assistance Now Oncology (PANO) offers quick and easy access to information about their wide range of resources. Here are some of the ways they can help: Provide information about financial or co-pay assistance that may be available through independent charitable foundations Offer support with insurance verification to help you understand your financial responsibilities and where to get your drugs Assist with changes in your insurance plan when your coverage changes Help you find a pharmacy covered by your plan and get medication based on your plan guidelines Provide Medicare education Support for Novartis Oncology medication You can get information about the PANO support programs in 2 ways: Call to speak with a representative dedicated to making access to therapy as simple and convenient as possible, or visit 16

17 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: 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 Continued on page 18. Please see additional Important Safety Information for PROMACTA (eltrombopag) also on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 17

18 IMPORTANT SAFETY INFORMATION FOR PROMACTA (eltrombopag) (continued) 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 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 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 Continued on page

19 IMPORTANT SAFETY INFORMATION FOR PROMACTA (eltrombopag) (continued) 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 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 that 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. Continued on page 20. Please see additional Important Safety Information for PROMACTA (eltrombopag) also on pages 17, 18, and 20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 19

20 IMPORTANT SAFETY INFORMATION FOR PROMACTA (eltrombopag) (continued) 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 Please see additional Important Safety Information for PROMACTA (eltrombopag) also on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 20

21 YOUR TREATMENT JOURNAL Stay UP to date with PROMACTA It s important to keep track of your treatment as it progresses. Make sure you update your health care team at every visit. This will ensure you re on the right path with your PROMACTA treatment and help you and your team identify where you may need more support. Date of doctor visit: Last visit, we discussed: After every doctor visit, log your platelet count in the tracker at the end of this brochure. This will give you valuable information about your treatment. 100,000 What are your goals for your next visit? Platelet count 80,000 60,000 40,000 20,000 Plot your platelet count after each blood test. 0 7/13 7/22 8/9 25 mg 25 mg 25 mg 100, ,000: A normal ra Fill in the date of your visit and your current treatment dosage. Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 21

22 YOUR TREATMENT JOURNAL Date: Date: Discussion: Discussion: Goals: Goals: 22

23 Date: Date: Discussion: Discussion: Goals: Goals: Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 23

24 YOUR TREATMENT JOURNAL 100,000 80,000 Platelet count 60,000 40,000 20,000 0 Date of visit Treatment dosage Talk to your doctor about any trends that you notice. 24

25 Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 25

26 Please see Important Safety Information for PROMACTA (eltrombopag) on pages Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. Novartis Pharmaceuticals Corporation East Hanover, New Jersey Novartis 4/17 PRM