LIVING. WITH PD. DAVID RYTARY patient since Fighting his symptoms. Embracing his life.

Transcription

1 Together, you and your doctor have chosen RYTARY for Parkinson s disease (PD). HERE S HOW TO GET STARTED. LIVING. WITH PD. DAVID RYTARY patient since Fighting his symptoms. Embracing his life. Do not take RYTARY with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors because taking these two drugs within two weeks of each other can result in high blood pressure. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 20-22, and Full Prescribing Information enclosed.

2 Prescribing Information Enclosed DAVID Diagnosed in LIFE. WITH PD. Taking RYTARY may result in falling asleep while engaged in normal activities, even without warning and as late as one year after starting to take RYTARY. Other sedating medicines and alcohol taken together with RYTARY may have additional sedative effects. Tell your healthcare provider if you have any kind of sleep disorder or are experiencing drowsiness or sleepiness.

3 WELCOME TO RYTARY. Carbidopa and levodopa extended-release capsules for the treatment of Parkinson s disease. Life with PD can be challenging, to say the least. You may find that OFF time is taking up more and more of your waking hours, leaving you less time in your daily life to do the things that matter to you. But RYTARY may help. RYTARY is an extended-release prescription therapy that may give you less OFF time and more ON time throughout the day. 1 Some side effects of taking RYTARY including sleepiness and dizziness may affect your ability to drive or operate machinery. Do not drive a car, operate a machine, or do anything that requires you to be alert until you know how RYTARY affects you. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 20-22, and Full Prescribing Information enclosed mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg 3

4 WHAT IS RYTARY? 1 RYTARY is an extended-release treatment for Parkinson s disease. It was approved by the U.S. Food and Drug Administration (FDA) in RYTARY contains a combination of carbidopa and levodopa (CD/LD), which is one of the most commonly used therapies for treating PD. 2 CD/LD medications work by replacing the dopamine in the brain that is lost due to Parkinson s disease. Dopamine is essential to good motor function, or the ability to move easily. 2 If you re currently on a CD/LD medication, you re most likely taking it in its immediate-release (IR) form. Combination CD/LD FDA approved Extended release Capsule Talk to your healthcare provider before you lower the dose or stop taking RYTARY, as this may result in serious side effects. Call your healthcare provider immediately if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness. Make sure to tell your healthcare provider if you have any heart conditions, especially if you have had a heart attack or experience irregular heartbeat. Some people with a history of or risk factors for heart disease have experienced heart problems while taking RYTARY. 4

5 BEVERLY RYTARY patient since Crafting with abandon. Living with purpose. Some patients taking RYTARY can experience hallucinations (unreal visions, sounds, or sensations) or abnormal thoughts and behaviors (such as excessive suspicion, believing things that are not real, confusion, agitation, aggressive behavior, and disorganized thinking). If you have hallucinations or abnormal thoughts or behaviors, talk with your healthcare provider. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 20-22, and Full Prescribing Information enclosed. 5

6 HOW DOES RYTARY WORK? 1 RYTARY delivers some medicine now and some medicine later. RYTARY is formulated so that your body does not receive all of the medication at once. Inside RYTARY capsules are different types of beads that allow medication to be used at different times: Immediate-release beads release some medication into your body soon after you swallow the capsules. Extended-release beads release the rest of the medication into your body for 4 to 5 hours after you take RYTARY. What happens to RYTARY after you take it? After you swallow the capsule, the medication is released from the capsule and is absorbed into your body. The medication stays in your body for about 4 to 5 hours. RYTARY is swallowed RYTARY is released RYTARY is still available in the body Some patients taking certain medicines to treat Parkinson s disease have intense urges to gamble, increased sexual urges, other intense urges, and the inability to control those urges. If you or your family members notice that you are developing unusual urges or behaviors, talk to your healthcare provider. Tell your healthcare provider if abnormal involuntary movements appear or get worse during treatment with RYTARY. 6

7 HOW CAN RYTARY HELP ME? In clinical studies of RYTARY: 1 People with early Parkinson s disease who took RYTARY experienced a significant improvement in their ability to move and perform activities during the day.* People with advanced Parkinson s disease who took RYTARY experienced significantly less OFF time, with more ON time without troublesome dyskinesia (uncontrollable movements) during the day. DURING THE DAY LESS OFF Time MORE ON Time WITHOUT Troublesome Dyskinesia Individual results may vary. * In a clinical study of patients with early Parkinson s disease, based on a scale to measure activities of daily living and ability to move (called the Unified Parkinson s Disease Rating Scale or UPDRS). 1 In a clinical study measuring off time during waking hours. 1 Tell your healthcare provider if you have ever had an ulcer, because RYTARY may increase your chances of having bleeding in your stomach. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 20-22, and Full Prescribing Information enclosed mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg 7

8 HOW IS RYTARY DOSED? RYTARY comes in 4 different dosage strengths. Your doctor may use one or more of these 4 RYTARY dosage strengths to find the dose and dosing frequency that works for you. In a clinical study, RYTARY was taken 3, 4, or a maximum of 5 times a day.¹ 95 mg* 145 mg* 195 mg* 245 mg* If RYTARY is your first CD/LD medication: Your doctor may start you on RYTARY 3 times a day and will determine the right dose. If you re converting from an immediate-release CD/LD: A different formulation means different dosing. This may mean higher or more frequent doses of RYTARY throughout the day. Taking more capsules does not mean you re getting worse. Your starting dose of levodopa in RYTARY will be higher than the previous dose in your IR CD/LD medication. In a clinical study, participants final total daily dose of levodopa in RYTARY was on average 2X higher than in their IR CD/LD dose. 1 Capsules may not be representative of actual size. *Levodopa Tell your healthcare provider if you have glaucoma, because RYTARY may increase the pressure in your eyes. 8

9 WHY MIGHT MY DOSE OF RYTARY BE ADJUSTED? Your dose may need adjustment. Be sure to tell your doctor if you experience the following: Delay in ON time after your first morning dose of RYTARY You may need a higher dose. OFF time between your RYTARY doses You may need higher or more frequent dosing. Any symptoms such as troublesome dyskinesia You may need a lower dose, or you may need to take your doses further apart. Based on this information, your doctor may change your dose or dosing frequency using the 4 RYTARY dosage strengths. The dose that works for you may be higher than your initial starting dose. 1 In a clinical study, 60% of participants needed an increase in their RYTARY starting dose while 16% needed a decrease, so anticipate adjustments. 1 It may take a few weeks to find the right dose and dosing frequency that works for you. This is common. That is why it s important to talk with your doctor. Parkinson s disease patients are at an increased risk of developing melanoma, a form of skin cancer. See your healthcare provider for regular skin examinations when taking RYTARY. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 20-22, and Full Prescribing Information enclosed mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg 9

10 HOW TO TAKE RYTARY. 1 By mouth Simply swallow the RYTARY capsule whole, with or without food. Do not chew, divide, or crush the capsule. Try to take the day s first dose of RYTARY about one or two hours before your first meal of the day, and keep in mind that high-fat, highcalorie meals eaten before taking RYTARY can delay its absorption by about two hours. Sprinkled over applesauce 1-2 TBS If you have trouble swallowing, you can sprinkle the contents of your RYTARY capsule over a small amount of applesauce. 1. Gently open the capsule by holding its ends and twisting. 2. Sprinkle ALL of the RYTARY capsule s contents onto one or two tablespoons of applesauce. 3. Immediately eat the applesauce along with ALL of the capsule s contents. The most common side effects that may occur with RYTARY include nausea, dizziness, headache, sleeplessness, abnormal dreams, dry mouth, abnormal involuntary movements, anxiety, constipation, vomiting, and low blood pressure upon rising. Rise slowly after sitting or lying down for a prolonged period. In post marketing use, some patients taking RYTARY have experienced suicidal thoughts or have attempted suicide. A causal relationship has not been established. Tell your healthcare provider if you have thoughts of suicide or have attempted suicide. 10

11 TALKING ABOUT PD. Communication is a two-way street. That s why it s essential that you and your healthcare provider speak the same language. This brief glossary of symptoms can help you have more meaningful conversations with your healthcare provider. OFF TIME is when your medication isn t working and you have to cope with your symptoms. You might feel stiff, move slowly, or not be able to get around easily because your symptoms are getting in the way. 3 ON TIME is when your symptoms are less apparent and you can go about your day. You feel more mobile and flexible, and are able to move around. 3 DYSKINESIA is a form of involuntary movement. Sometimes your dyskinesia may not bother you. However, there is also troublesome dyskinesia, defined as uncontrollable movements that get in the way of your daily activities. 3 Tell your healthcare provider if you have any side effects while taking RYTARY. He or she can make adjustments that may reduce these effects. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 20-22, and Full Prescribing Information enclosed mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg 11

12 LIVING. WITH PD. Nobody ever said living with PD was easy. RYTARY may improve your ability to move freely, and perform activities of daily life, by providing less OFF time, and more ON time. 1 Maintaining a healthy lifestyle is important, too. Eat a balanced diet, exercise your body and mind, and don t be afraid to ask your family and caregivers for support. Notify your healthcare provider if you become pregnant or intend to become pregnant during therapy or if you intend to breast-feed or are breast-feeding an infant. Make sure you tell your healthcare provider about all of the prescription and non-prescription medications you take, including supplements, and especially those for Parkinson s disease, heart disease, blood pressure, abnormal thoughts, tuberculosis, and sleep problems, and supplements containing iron. Do not take other carbidopa-levodopa preparations with RYTARY without consulting your healthcare provider. 12

13 STEVE RYTARY patient since Shooting straight. Scoring eagles. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 20-22, and Full Prescribing Information enclosed. 13

14 REAL PEOPLE. REAL STORIES. Meet people with PD who are taking RYTARY. Their stories can be seen at RYTARY.com. Be sure to take your medicine as instructed. You may take RYTARY with or without food; however, taking RYTARY with food may decrease or delay its effect. For this reason consider taking the first dose of the day about 1 to 2 hours before eating. Swallow RYTARY whole; do not chew, divide, or crush. If you have difficulty swallowing the capsule, twist apart both halves and sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons). Consume the mixture immediately. Do not store the drug/food mixture for future use. 14

15 RYTARY PATIENT RESOURCES The more involved you become in your own treatment, the more control you ll have over your symptoms and your life. RYTARY Patient Resources can help. Symptom Journal Record your symptoms so you can have more meaningful conversations with your healthcare provider. RYTARY Reminders Keep this booklet handy to remind you when and how to take your RYTARY dose. RYTARY.com Visit RYTARY.com for more information about your treatment and living with Parkinson s disease. Rx MyRYTARY Patient Support Program Get one-on-one support to help you get on, pay for, and stay on RYTARY. Find out more on the next page. Note: The above information for patients being treated with RYTARY is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 20-22, and Full Prescribing Information enclosed mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg 15

16 PATIENT SUPPORT PROGRAM You re not alone on your treatment journey. With MyRYTARY, you get free personalized support that helps you: Rx Get on Rytary Pay for Rytary Stay on Rytary We will contact your insurance provider to determine your coverage, help you navigate the approval process, find options that may make your treatment more affordable, and give you the information you need to stay on RYTARY and stay healthy. GETTING STARTED IS EASY. VISIT MYRYTARY.COM OR CALL IMPAX2U ( ) 16

17 GETTING ON RYTARY Rx We will contact your insurance provider to help determine your coverage, and help you navigate the approval process through: Rapid benefits investigation Assistance in understanding and navigating the prior authorization process Assistance with the exception and appeals process, if required This program provides you with RYTARY at no cost during the payer approval and dose adjustment processes. -- Up to three (3) months -- If delays in the Payer Approval process persist beyond three (3) months, additional free product may be available upon request. Please call for terms and conditions mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg 17

18 If you fill 2 dosage PAYING FOR RYTARY We can help you find options that may make RYTARY more affordable, regardless of your insurance type. PRIVATE/COMMERCIAL HEALTH INSURANCE Rytary Co-Pay Savings Card If you have commercial health insurance and meet eligibility requirements, you will pay no more than $25 per month* for RYTARY. Up to a maximum benefit of $ Applies to both first and, if required, second co-pay. Not valid for patients enrolled in Medicare or Medicaid PAY AS LITTLE AS RYTARY CO-PAY SAVINGS CARD Eligible patients: Save on your RYTARY prescription! This card must be activated before use. To activate your card, please call If you have any questions, please call us (8:30 am-5:30 pm ET, Monday-Friday) at BIN Number: RxPCN: CN Group Number: XXXXXXXX Cardholder ID: XXXXXXXXXXXX Please see terms and eligibility criteria on reverse side. $25 * *Up to a maximum benefit of $ strengths per month, your 2ND CO-PAY may be $0 * MEDICARE OR MEDICAID Foundation Referral If you need additional financial support, we can provide you information on independent foundations that may be able to help. LIMITED OR NO INSURANCE The MyRYTARY Patient Assistance Program may be able to provide you with extra financial assistance. Learn more at RYTARY.com/patients-resources or call * Up to $100 maximum benefit. See terms, conditions, and eligibility criteria at RYTARY.com/patient-resources.

19 STAYING ON RYTARY After you enroll, we will assign you a dedicated MyRYTARY Case Manager. He or she will provide you with one-to-one support every step of the way from explaining your insurance coverage to providing ongoing information through: Case Management Informational phone calls about RYTARY Educational Resources Ongoing tips, tools, and other resources sent via mail, , and text GETTING STARTED IS EASY. VISIT MYRYTARY.COM OR CALL IMPAX2U ( ) mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg 19

20 Indication RYTARY is a prescription medication that contains a combination of carbidopa and levodopa for the treatment of Parkinson s disease, Parkinson s disease caused by infection or inflammation of the brain, or Parkinson s disease resulting from carbon monoxide or manganese poisoning. Do not take RYTARY with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors because taking these two drugs within two weeks of each other can result in high blood pressure. Taking RYTARY may result in falling asleep while engaged in normal activities, even without warning and as late as one year after starting to take RYTARY. Other sedating medicines and alcohol taken together with RYTARY may have additional sedative effects. Tell your healthcare provider if you have any kind of sleep disorder or are experiencing drowsiness or sleepiness. Some side effects of taking RYTARY including sleepiness and dizziness may affect your ability to drive or operate machinery. Do not drive a car, operate a machine, or do anything that requires you to be alert until you know how RYTARY affects you. Talk to your healthcare provider before you lower the dose or stop taking RYTARY, as this may result in serious side effects. Call your healthcare provider immediately if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness. Make sure to tell your healthcare provider if you have any heart conditions, especially if you have had a heart attack or experience irregular heartbeat. Some people with a history of or risk factors for heart disease have experienced heart problems while taking RYTARY. Some patients taking RYTARY can experience hallucinations (unreal visions, sounds, or sensations) or abnormal thoughts and behaviors (such as excessive suspicion, believing things that are not real, confusion, agitation, aggressive behavior, and disorganized thinking). If you have hallucinations or abnormal thoughts or behaviors, talk with your healthcare provider. Some patients taking certain medicines to treat Parkinson s disease have intense urges to gamble, increased sexual urges, other intense urges, and the inability to control those urges. If you or your family members notice that you are developing unusual urges or behaviors, talk to your healthcare provider. 20

21 Tell your healthcare provider if abnormal involuntary movements appear or get worse during treatment with RYTARY. Tell your healthcare provider if you have ever had an ulcer, because RYTARY may increase your chances of having bleeding in your stomach. Tell your healthcare provider if you have glaucoma, because RYTARY may increase the pressure in your eyes. Parkinson s disease patients are at an increased risk of developing melanoma, a form of skin cancer. See your healthcare provider for regular skin examinations when taking RYTARY. The most common side effects that may occur with RYTARY include nausea, dizziness, headache, sleeplessness, abnormal dreams, dry mouth, abnormal involuntary movements, anxiety, constipation, vomiting, and low blood pressure upon rising. Rise slowly after sitting or lying down for a prolonged period. In post marketing use, some patients taking RYTARY have experienced suicidal thoughts or have attempted suicide. A causal relationship has not been established. Tell your healthcare provider if you have thoughts of suicide or have attempted suicide. Tell your healthcare provider if you have any side effects while taking RYTARY. He or she can make adjustments that may reduce these effects. Notify your healthcare provider if you become pregnant or intend to become pregnant during therapy or if you intend to breast-feed or are breast-feeding an infant. Make sure you tell your healthcare provider about all of the prescription and non-prescription medications you take, including supplements, and especially those for Parkinson s disease, heart disease, blood pressure, abnormal thoughts, tuberculosis, and sleep problems, and supplements containing iron. Do not take other carbidopa-levodopa preparations with RYTARY without consulting your healthcare provider. Be sure to take your medicine as instructed. You may take RYTARY with or without food; however, taking RYTARY with food may decrease or delay mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg 21

22 its effect. For this reason consider taking the first dose of the day about 1 to 2 hours before eating. Swallow RYTARY whole; do not chew, divide, or crush. If you have difficulty swallowing the capsule, twist apart both halves and sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons). Consume the mixture immediately. Do not store the drug/food mixture for future use. Note: The above information for patients being treated with RYTARY is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at Please read the accompanying Full Prescribing Information. For more information, go to RYTARY.com and/or talk to your healthcare provider. References 1 RYTARY [package insert]. Hayward, CA: Impax Laboratories, Inc.; Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease. Neurology. 2009;72(suppl 4):S1-S Hauser RA, Friedlander J, Zesiewicz TA, et al. A home diary to assess functional status in patients with Parkinson s disease with motor fluctuations and dyskinesia. Clin Neuropharmacol. 2000;23(2):

23 JOANNE RYTARY patient since Dancing for joy. Finding her balance. 23

24 PATIENT SUPPORT PROGRAM You re not alone on your treatment journey. With MyRYTARY, you get free personalized support that helps you: Rx Get on Rytary Pay for Rytary Stay on Rytary We will contact your insurance provider to determine your coverage, help you navigate the approval process, find options that may make your treatment more affordable, and give you the information you need to stay on RYTARY and stay healthy. GETTING STARTED IS EASY. VISIT MYRYTARY.COM OR CALL IMPAX2U ( ) 2017 Impax Laboratories, Inc. All rights reserved. Printed in USA. PP-PAT-RYT-US / mg / 95 mg mg / 145 mg mg / 195 mg mg / 245 mg