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 Important Safety Information for PROMACTA on pages 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. WITH MY ONCE-DAILY TABLET FOR THE COUNT I’M UP
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INDICATIONSPROMACTA 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 Important Safety Information for PROMACTA on pages 17-20.
Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.
What is PROMACTA?Side effectsTaking PROMACTAPatient Support ProgramQuestions for your doctorFinancial assistanceTracking your progress
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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.*
*The results seen with PROMACTA were similar among patients who were either• Taking other medications to treat their cITP 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 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 2
PROMACTA is a once-daily tablet that may raise platelet levels in patients with cITP.*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.
She said with my platelets still low after my first course of treatment, a different medicine could help. Fingers crossed!
Please see Important Safety Information for PROMACTA® (eltrombopag) on pages 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.
* Target range defined as platelet counts of 50-400 billion per liter (50-400 x 109 L) during the 6-month period that patients received PROMACTA or placebo.
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.
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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 www.fda.gov/medwatch or call 1-800-FDA-1088.
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 (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 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.
PROMACTA can cause serious side effects, including:
• Liver problems • Worsening of a precancerous blood
condition to a blood cancer called acute myelogenous leukemia (AML)
• Abnormal liver function tests• High platelet counts and higher
Your doctor will prescribe the right dose for you.
PROMACTA tablets are taken once-daily and are available in 4 strengths.
Tablets not actual size.
12.5 mg 25 mg 50 mg 75 mg
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 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.
I’m making PROMACTA part of my daily routine. The mealtime considerations are important and help PROMACTA work properly.
I take PROMACTA at least 1 hour
When I have more than 50 mg of
before or 2 hours after a meal.
2 hours before or 4 hours after.calcium: I take PROMACTA at least
• 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.
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.
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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.
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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 got the PROMACTA Meal Planner today
You can always download a copy from our site at www.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 don’t eat any dairy-rich
I don’t eat any food after 7:00 PM
I take PROMACTA at 9:00 PM
Please see Important Safety Information for PROMACTA® (eltrombopag) on pages 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.
products after 5:00 PMfrom my doctor. It offers tips and examples to help me manage my new routine!
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 e-mails, 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 17-20. Please see full Prescribing Information, including Boxed WARNING, and Medication Guide in pocket.
You may have many questions about cITP 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 cITP 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?
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To find out if you are eligible, call 1-877-577-7756, or visit www.CoPay.NovartisOncology.com
Universal Co-pay CardSave on your out-of-pocket costs
Limitations apply. Offer is not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice.
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 (877) 577-7756 or visit www.CoPay.NovartisOncology.com
Limitations apply. See program Terms and Conditions.
Terms and ConditionsThis 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 payments, 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 the 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, 2018. Additional Terms and Conditions may apply.
Patient InstructionsPresent this offer and your insurance card along with a valid prescription at any participating pharmacy or through mail order. Patients with commercial insurance are responsible for $25 per 30-day supply and Novartis pays up to $15,000 per calendar year. If patient reaches the maximum annual cap per calendar year of $15,000, patient will be responsible for the difference. This offer expires on December 31, 2018. Patient questions should be directed to: 877-577-7756. 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 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.
PROMACTA OFFERS FINANCIAL SUPPORT THROUGH THE UNIVERSAL CO-PAY CARD AND PATIENT ASSISTANCE NOW ONCOLOGY
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 1-800-282-7630 to speak with a representative dedicated to making access to therapy as simple and convenient as possible, or visit www.OncologyAccessNow.com.
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.
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 18-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 17
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 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
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.
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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• rashThe 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 testsLaboratory 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 1-800-FDA-1088.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
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 www.PROMACTA.com or call 1-888-669-6682.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.
Please see additional Important Safety Information for PROMACTA® (eltrombopag) also on pages 17-19. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 20
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.
YOUR TREATMENT JOURNAL
Stay UP to date with PROMACTA
Date of doctor visit:
Last visit, we discussed:
What are your goals for your next visit?
Fill in the date of your visit and your current treatment dosage.
Plot your platelet count after each blood test.
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.
Please see Important Safety Information for PROMACTA® (eltrombopag) on pages 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 21
Please see Important Safety Information for PROMACTA® (eltrombopag) on pages 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide. 23
Talk to your doctor about any trends that you notice.
YOUR TREATMENT JOURNAL
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25Please see Important Safety Information for PROMACTA® (eltrombopag) on pages 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.
Please see Important Safety Information for PROMACTA® (eltrombopag) on pages 17-20. Please click here for full Prescribing Information, including Boxed WARNING, and Medication Guide.
