(safinamide) tablets

Transcription

1 FOR PARKINSON S DISEASE (PD) GET TO KNOW XADAGO can increase your daily on time without troublesome dyskinesia (uncontrolled movement) Please see the complete on pages and

2 For Parkinson s disease (PD) Introducing once-daily XADAGO XADAGO (safi namide) is a prescription-only monoamine oxidase type B (MAO-B) inhibitor, which is used as an add-on with levodopa/carbidopa for PD patients. XADAGO can help reduce your off time (or off episodes) and increase your daily on time without troublesome dyskinesia.* It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy). It is not known if XADAGO is safe and effective in children. What s an MAO-B inhibitor? MAO-B is an enzyme that naturally breaks down chemicals in the brain, including dopamine. A shortage of dopamine in your brain can cause impaired movement and PD motor symptoms like stiffness (rigidity), freezing, and shaking (tremor). XADAGO is a medication that helps prevent MAO-B from breaking down dopamine in your brain. Adding XADAGO to your levodopa/carbidopa medicine may increase your dopamine levels and reduce some of your PD motor symptoms. Normal Dopamine With PD TALK TO YOUR HEALTHCARE PROVIDER IF YOU WANT MORE ON TIME AND LESS OFF TIME *Like any medication, XADAGO may not have the same effect on every person and may cause side effects. Tell your physician if you are taking, or planning to take, any prescription or over-the-counter drugs. Do not take XADAGO if you are taking other monoamine oxidase inhibitors (MAOIs), as it could cause a sudden severe increase in your blood pressure. The combination of MAO-B inhibitors such as XADAGO and antidepressants has resulted in a serious and sometimes fatal condition called serotonin syndrome. Please see the complete on pages and 2 3 XADAGO HELPS BLOCK THE LOSS OF DOPAMINE IN THE BRAIN

3 What is ON and OFF time? During a typical day, PD patients experience on time and off time. In addition, on time can be accompanied by troublesome dyskinesia. ON TIME is when: Your oral levodopa/carbidopa medication is working well Your PD symptoms are at a minimum You are moving and able to go about your day What is XADAGO? XADAGO is a tablet you take once a day to treat the motor symptoms of PD. Since XADAGO is an add-on, that means it is used along with your levodopa/carbidopa medication. As shown in clinical trials, XADAGO can: Increase daily on time without troublesome dyskinesia OFF TIME (or off episodes) is when: Your oral levodopa/carbidopa medication isn t working Your PD symptoms have re-emerged and are at or near their worst Symptoms like stiffness (rigidity), freezing, shaking (tremor), or diffi culty moving get in the way of your daily tasks TROUBLESOME DYSKINESIA is when: + Reduce off time and off time symptoms Help improve patients ability to move and take on their day And, a majority of PD patients taking XADAGO were able to maintain their current levodopa/carbidopa dose Uncontrollable (involuntary), abnormal movements interfere with your daily activities These movements often occur as a side effect of long-term treatment with levodopa/carbidopa Do not take XADAGO with opioid medications including meperidine, tramadol, methadone, or propoxyphene, as this could result in serious, sometimes fatal, reactions. Also, do not take XADAGO with amphetamine, cyclobenzaprine, methylphenidate, or St. John s wort. Taking these drugs together can also result in serotonin syndrome, which could be fatal. Do not use XADAGO with dextromethorphan, as this has been reported to cause episodes of psychosis or abnormal behavior. Please see the complete on pages and 4 5 XADAGO IS A PD TREATMENT YOU ADD-ON TO YOUR LEVODOPA/CARBIDOPA MEDICINE

4 How do I take XADAGO? XADAGO is taken once-daily in addition to your levodopa/carbidopa medicine. If you are taking levodopa/carbidopa, XADAGO can: Provide more daily on time without troublesome dyskinesia 50 mg* 100 mg* Reduce the amount of off time that you experience during the day The recommended starting dose of XADAGO is 50 mg once daily Help improve your ability to move and take on your day After 2 weeks, your healthcare provider may decide to increase your daily dose to 100 mg once daily, if necessary *Images above are not actual size of XADAGO tablets ADDING ONCE-DAILY XADAGO CAN HELP IF YOU ARE EXPERIENCING OFF TIME Once-daily XADAGO can be taken with or without food and at any time of the day. If you are experiencing side effects, or feel like you re not getting the symptom relief you need, be sure to talk to your healthcare provider as soon as possible. Do not change your dose or stop taking XADAGO unless your healthcare provider tells you to. Do not use XADAGO if you have hypersensitivity to safinamide, as this can cause swelling of the tongue and mouth and trouble breathing. XADAGO CAN HELP YOU BE AND TAKE ON YOUR DAY You should not take XADAGO if you have severe liver disease. Do not exceed a dose of 50 mg per day of XADAGO if you have moderate liver disease. During treatment with XADAGO you may experience increases in blood pressure. Inform your physician if you have a history of high blood pressure. 6 READY TO GO Please see the complete on pages and 7

5 Is XADAGO right for me? Over time, with long-term levodopa/carbidopa treatment, you may start to experience decreased on time and may be having more off time. If you are experiencing off time, and notice that your PD symptoms, like stiffness (rigidity), freezing, shaking (tremor), or diffi culty moving, are not controlled with your levodopa/carbidopa, ask your healthcare provider if XADAGO may be right for you. XADAGO is a once-daily tablet that can help give you more on time (without troublesome dyskinesia), so you can get back to and GO about your day. LESS OFF TIME MORE ON TIME TALK TO YOUR HEALTHCARE PROVIDER ABOUT HOW XADAGO CAN HELP INCREASE ON TIME WITHOUT TROUBLESOME DYSKINESIA What are the possible side effects of XADAGO? Before taking XADAGO, tell your healthcare provider about all medications and supplements you are taking and ask your healthcare provider what medications you shouldn t take with XADAGO. The most common side effects of XADAGO include uncontrolled, sudden movements (dyskinesia), falls, nausea, trouble sleeping or falling asleep (insomnia). Ask your healthcare provider about which side effects are likely to occur and what PD symptoms you should watch for. Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all of the possible side effects of XADAGO. For more information, call your healthcare provider for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at ( XADAGO). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at FDA-1088 or Please see the complete on pages and the accompanying full Prescribing Information and Patient Information. Possible symptoms of an unsafe rise in blood pressure include severe headache, blurred vision, confusion, seizures, shortness of breath, severe anxiety, and nausea and vomiting. Contact your doctor or seek immediate medical attention if you experience any of these symptoms. Some patients treated with XADAGO experienced drowsiness or sudden onset of sleep. Do not drive, operate heavy machinery, work in high places or do other dangerous activities until you know how XADAGO affects you. 8 9

6 Is there a savings program with XADAGO? Rx Here s how it works XADAGO Prescription Savings Program Yes the XADAGO Prescription Savings Program is here to help you with fi nancial assistance so you can get your prescription when you need it.* As a participant in the evoucherrx Program powered by RelayHealth, US WorldMeds has made it possible to extend prescription savings on to you. evoucherrx is a paperless electronic coupon program that makes co-pay savings on your prescription for XADAGO easy for you and your healthcare provider. Simply take your prescription for XADAGO to a participating pharmacy and the evoucherrx savings coupon will be automatically applied to your co-pay.* *Restrictions may apply. For more information, visit xadago.com Pay as little as $25* (save up to $125) on your XADAGO prescription each month The XADAGO Prescription Savings Program provides you with up to $125 co-pay assistance per month over 12 months. For more information about the XADAGO Prescription Savings Program, or to find a participating pharmacy, visit XADAGO.com/pharmacy. *Patients whose prescriptions will be paid for in part or in whole by Medicare, Medicaid, or any similar federal or state healthcare program, are not eligible for savings or rebates according to federal and state law. Restriction of foods and beverages containing tyramine is usually not required when treated with the recommended doses of XADAGO. However, it is recommended that you avoid foods containing high amounts of tyramine, such as aged cheeses, as some patients may have an increased sensitivity that could lead to an unsafe rise in blood pressure. Please see the complete on pages and 10 11

7 Together We re here to help you understand and manage your care or the care of your loved one with once-daily XADAGO. The XADAGO Together Program is your resource for: XADAGO and PD information XADAGO refill reminders Savings on your XADAGO prescriptions* Tools to help you talk to your healthcare provider about XADAGO Lifestyle tips for patients with PD and their care partners VISIT XADAGO.COM TODAY TO JOIN *Eligibility restrictions may apply. For more information, visit xadago.com. The most common side effects seen with XADAGO are uncontrolled movements (dyskinesia), falls, nausea, and insomnia. To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at ( XADAGO). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at FDA-1088 or 12 Please see the complete on pages and 13

8 Indication XADAGO (safi namide) is a type of prescription medicine known as monoamine oxidase type B (MAO-B) inhibitor used with levodopa and carbidopa to treat adults with Parkinson s disease (PD) who are having off episodes. It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy). It is not known if XADAGO is safe and effective in children. for Patients Tell your physician if you are taking, or planning to take, any prescription or over-the-counter drugs. Do not take XADAGO if you are taking other monoamine oxidase inhibitors (MAOIs), as it could cause a sudden severe increase in your blood pressure. The combination of MAO-B inhibitors such as XADAGO and antidepressants has resulted in a serious and sometimes fatal condition called serotonin syndrome. Do not take XADAGO with opioid medications including meperidine, tramadol, methadone, or propoxyphene, as this could result in serious, sometimes fatal, reactions. Also, do not take XADAGO with amphetamine, cyclobenzaprine, methylphenidate, or St. John s wort. Taking these drugs together can also result in serotonin syndrome, which could be fatal. Do not use XADAGO with dextromethorphan, as this has been reported to cause episodes of psychosis or abnormal behavior. Do not use XADAGO if you have hypersensitivity to safi namide, as this can cause swelling of the tongue and mouth and trouble breathing. You should not take XADAGO if you have severe liver disease. Do not exceed a dose of 50 mg per day of XADAGO if you have moderate liver disease. During treatment with XADAGO you may experience increases in blood pressure. Inform your physician if you have a history of high blood pressure. Possible symptoms of an unsafe rise in blood pressure include severe headache, blurred vision, confusion, seizures, shortness of breath, severe anxiety, and nausea and vomiting. Contact your doctor or seek immediate medical attention if you experience any of these symptoms. Some patients treated with XADAGO experienced drowsiness or sudden onset of sleep. Do not drive, operate heavy machinery, work in high places or do other dangerous activities until you know how XADAGO affects you. Restriction of foods and beverages containing tyramine is usually not required when treated with the recommended doses of XADAGO. However, it is recommended that you avoid foods containing high amounts of tyramine, such as aged cheeses, as some patients may have an increased sensitivity that could lead to an unsafe rise in blood pressure. The most common side effects seen with XADAGO are uncontrolled movements (dyskinesia), falls, nausea, and insomnia. To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at ( XADAGO). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at FDA-1088 or Please see full Prescribing Information and Patient Information at

9 TM Get to know XADAGO Once-daily XADAGO can: Provide more daily on time without troublesome dyskinesia Reduce the amount of off time that you experience during the day Improve your ability to move and take on your day Visit XADAGO.COM today and learn more Please see the complete on pages and the accompanying full Prescribing Information and Patient Information. Under License from Newron Pharmaceuticals SpA. US WorldMeds, LLC is the exclusive licensee and distributor of XADAGO in the United States and Its territories Zambon SpA. XADAGO is a registered trademark of Zambon SpA. USWM-XAD018A-0617