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Together, you and your doctor have chosen RYTARY LOOK INSIDE FOR SAVINGS An Extended-Release Treatment for Parkinson’s Disease Important Safety Information Do not take RYTARY with an antidepressant medication class known as nonselective monoamine oxidase (MAO) inhibitors because high blood pressure can result. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg Welcome to RYTARY (carbidopa and levodopa) extended-release capsules If you’re living with Parkinson’s disease, you want to live in the moment, not in your symptoms. Now, an extended-release prescription therapy called RYTARY (rye-TAR-ee) may help. With RYTARY, you may be able to spend less time focusing on your “off” time and more time getting back to your daily activities and the people you love. R Y TA R Y I S F O R Imagine time when the focus is on you, not on your symptoms E AR LY M OD E R ATE AD VAN CE D PAR K IN SON ’S D ISE ASE Important Safety Information Important Safety Information 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. Central nervous system depressants 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. 2 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 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 3 What is RYTARY?1 In clinical studies of RYTARY 1 An extended-release treatment for Parkinson’s disease. • Patients with early Parkinson’s disease who took RYTARY experienced a significant improvement in their ability to move and perform activities during the day.* ... z ... FDA approved ... Combination treatment ... ... Extended release • Patients 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.† 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 * Capsule DURING T H E DAY • RYTARY is an extended-release carbidopa and levodopa capsule approved by the US Food and Drug Administration (FDA) in 2015. • The combination of carbidopa and levodopa is one of the most commonly used therapies for treating Parkinson’s disease symptoms.2 Less “OFF” Time More “ON” Time Without Troublesome Dyskinesia Important Safety Information Important Safety Information Do not quickly lower or change your dose or suddenly stop taking RYTARY without talking to your healthcare provider as this may result in developing serious side effects. Call your healthcare provider immediately if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness. 4 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 taking RYTARY have experienced heart problems while taking RYTARY. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 5 Two ways to take RYTARY 1 When taking RYTARY with food1 1. Swallow the capsule whole • Do not chew, divide, or crush RYTARY. • Know that a high-fat, high-calorie meal before you take RYTARY can delay the absorption of RYTARY by about 2 hours. For this reason, consideration should be given to taking the first dose of the day about 1 to 2 hours before eating. 2. Sprinkle onto applesauce • Foods rich in protein or amino acids may decrease the absorption of RYTARY. • You can take RYTARY with or without food. You can take your RYTARY dose by sprinkling it onto a small amount (1-2 tablespoons) of applesauce. • Gently open the RYTARY capsule by holding the ends of the capsule and twisting it open. • Then sprinkle the entire contents of the RYTARY capsule onto approximately 1-2 tablespoons of applesauce. • Eat the applesauce and the entire contents of RYTARY immediately. 1-2 TBS Important Safety Information Y O U C A N TAKE RY TARY WI T H APPLES AUC E Important Safety Information Patients taking RYTARY can also 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. 6 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. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 7 Learn more about RYTARY 1 • You will start taking RYTARY 3 times a day. Your doctor will determine the right dose of RYTARY for you to take. THE STARTING DOSE IS 3x A DAY • Because of the way RYTARY is formulated, the dose of levodopa in RYTARY may be higher than what you have received before. Important information you need to know about RYTARY 1 • Always follow the recommendations of your doctor or healthcare provider. • Do not quickly lower your dose or suddenly stop taking RYTARY without first talking to your healthcare provider. Certain serious side effects may occur when stopping or reducing levodopa. You may develop fever, confusion, or severe muscle stiffness.1 • Store RYTARY at 77°F (25°C). • Tell your doctor about any side effects you experience. What happens to RYTARY after you take it?1 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. Important Safety Information Tell your healthcare provider if abnormal involuntary movements appear or get worse during treatment with RYTARY. 8 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. To report SUSPECTED ADVERSE REACTIONS, contact Impax Laboratories, Inc. at 1-877-994-6729. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 9 Goals to aim for when you live with Parkinson’s disease2 Know the difference between your “off” time and “on” time Depending on your stage of Parkinson’s disease, you may be experiencing “off” time and “on” time. 1 Maintaining current activity level 2 “OFF” TIME is when your medication isn’t working and you 2 Experiencing more “on” time by decreasing “off” time “ON” TIME is when your symptoms are less apparent and have to cope with your symptoms. You might feel stiff, move slowly, or not be able to get around so easily because your symptoms are getting in the way.3 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 3 Being able to move and perform daily tasks1 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 FOCUS ON THE DAILY GOAL: Experience less 4 Maintaining relationships with family and friends “off” time each day and more “on” time without troublesome dyskinesia (uncontrollable movements). Important Safety Information Tell your healthcare provider if you have glaucoma, because RYTARY may increase the pressure in your eyes. Important Safety Information Tell your healthcare provider if you have ever had an ulcer, because RYTARY may increase your chances of having bleeding in your stomach. 10 Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 11 Important Safety Information INDICATION RYTARY (rye-TAR-ee) is a prescription medication that contains 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. IMPORTANT SAFETY INFORMATION—for patients Do not take RYTARY with an antidepressant medication class known as nonselective monoamine oxidase (MAO) inhibitors because high blood pressure can result. 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. Central nervous system depressants 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. Do not quickly lower or change your dose or suddenly stop taking RYTARY without talking to your healthcare provider as this may result in developing 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 taking RYTARY have experienced heart problems while taking RYTARY. 12 Patients taking RYTARY can also 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. 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. Tell your healthcare provider if you have any side effects while taking RYTARY. He or she can make adjustments that may reduce those effects. 48.75 mg / 195 mg • 61.25 mg / 245 mg 13 Important Safety Information, cont. Notify your healthcare provider if you become pregnant or intend to become pregnant during therapy or if you intend to breastfeed or are breast-feeding an infant. Facts about Parkinson’s disease 1M 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. PEOPLE 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 may be carefully opened and the entire contents sprinkled on a small amount of applesauce (1 to 2 tablespoons) and taken immediately. 60s 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 read the Full Prescribing Information and talk to your healthcare provider for more information concerning your treatment if you have questions, or go to RYTARY.com. 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. To report SUSPECTED ADVERSE REACTIONS contact Impax Laboratories, Inc. at 1-877-994-6729. LE ARN MORE AT RY TARY.COM 14 YOUR Approximately 1 million people in the US have Parkinson’s disease.4 Most people with Parkinson’s disease are diagnosed while in their 60s.2 1967 In the early 1960s, levodopa was first introduced as a medication. Yet, it wasn’t until 1967 that doctors started using it regularly with patients.5 1817 Parkinson’s disease is named for the English physician Dr. James Parkinson. He wrote an essay about the condition back in 1817. To honor his birthday, April 11 is World Parkinson’s Day.6 Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 15 Living with Parkinson’s disease Exercising body and mind Each year in the United States, around 60,000 people learn that they have Parkinson’s disease.4 While hearing this news is never easy, you can take steps in the right direction. Start by making positive lifestyle changes, learn as much as you can about your medication, and stay optimistic. Patients with Parkinson’s disease who exercise do better than those patients who don’t.8 So if you have a favorite exercise or activity that you enjoy, stick with it. For the body9: • Walking. Three areas that can help: • Yoga/tai chi. • Marching to music while swinging your arms. • Aerobics or dance class. • Video sports games and balance activities— involve your grandkids. • Be sure to tailor the exercise to your abilities, and talk to your doctor before starting any exercise plan. Eating Well Body & Mind Family/Caregivers Eating well Good nutrition is important at any age. With Parkinson’s, there are a few goals to keep in mind: • Eat a balanced diet. Ask your doctor or talk to a nutritionist if you need help.7 • Fiber can be helpful. • Drink enough water. • Tell your doctor about all medications you take, including vitamins or supplements. 16 For the mind9: • Jigsaw or crossword puzzles. • Board games or card games. • Sudoku or other memory games. Important Safety Information 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 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 17 Involving your family and caregivers Tips for caregivers10 Taking care of your health is a team effort. This includes you, your doctor, your family, and any other friends or caregivers who may support you. Good communication can help you stay on top of your condition. Be sure to tell your family and caregivers as much as you can about how you are feeling so that they can support you as much as possible. Talk Openly Learn More Find Support 1. Respect the journey. Even though you might have an idea of what a loved one is going through, only he or she can understand the journey. Be respectful. 2. T alk openly. It’s important to communicate with each other about your feelings on both sides. 3. D on’t let this disease take over. Your loved one may have a disease, but he or she is not “the” disease. While this is a challenge, don’t forget who your loved one is. 4. Learn more. Educate yourself as much as you can about Parkinson’s disease. You don’t need to learn it all at once. Take your time. 5. Find a support group. Seek help from friends, family, and other caregivers. Plus, you can give back and support others. 6. T ake care of yourself. Spend time relaxing and choosing enjoyable activities, and make time for you. Important Safety Information 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. 18 Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 19 More resources American Parkinson Disease Association 1.800.223.2732 apdaparkinson.org National Parkinson Foundation 1.800.473.4636 parkinson.org The Michael J. Fox Foundation for Parkinson’s Research 1.800.708.7644 michaeljfox.org Parkinson’s Disease Foundation 1.800.457.6676 pdf.org Two options to help you pay for your RYTARY prescription If you need help paying for your prescription, there are several options available. FO R T H OSE W I T H PR I VAT E I NSU R A N C E Get the RYTARY Co-Pay Savings Card for help in paying for your RYTARY prescription. Whether your doctor has prescribed one strength of RYTARY or two, you may be able to save. See the RYTARY Co-pay Savings Card brochure for terms, conditions, and eligibility criteria. FO R T H OSE W I T H LI T T LE O R N O I NSU R A N C E References: 1. RYTARY [package insert]. Hayward, CA: Impax Laboratories, Inc.; 2015. 2. Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease. Neurology. 2009;72(suppl 4):S1-S136. 3. 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):75-81. 4. Parkinson’s disease overview. National Parkinson Foundation website. http://www.parkinson.org/parkinson-s-disease.aspx. Accessed August 10, 2014. 5. Tolosa E, Marti MJ, Valldeoriola F, Molineuvo JL. History of levodopa and dopamine agonists in Parkinson’s disease treatment. Neurology. 1998;50(6 suppl 6):S2-S10, S44-S48. 6. Dr James Parkinson. Parkinson’s UK website. http://www.parkinsons.org.uk/content/dr-james-parkinson. Accessed August 10, 2014. 7. Traviss K. Nutrition and Parkinson’s disease: what matters most? Parkinson’s Disease Foundation website. http://www.pdf.org/ en/winter06_07_Nutrition_and_Parkinson. Accessed August 10, 2014. 8. Golbe LI, Mark MH, Sage JI. Parkinson’s Disease Handbook. New Brunswick, NJ: The American Parkinson’s Disease Association, Inc; 2010:21-31. 9. Exercise and physical therapy. Parkinson’s Disease Clinic and Research Center at UCSF website. http://pdcenter.neurology.ucsf.edu/patients-guide/exercise-and-physical-therapy. Accessed August 10, 2014. 10. The PD partnership: tips for people with PD and their care partners. Parkinson’s Disease Foundation website. www.pdf.org/pdf/ fs_pd_partnership_08.pdf. Accessed August 10, 2014. 20 Through the RYTARY Patient Assistance Program, people with limited income or no insurance may be eligible for extra financial assistance. Call 1-877-764-9021 to learn more. Important Safety Information Tell your healthcare provider if you have any side effects while taking RYTARY. He or she can make adjustments that may reduce those effects. Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 21 The MyRYTARY™ Patient Resources Program is here to support you The MyRYTARY ™ Patient Resources Program is here to support you and your caregivers with helpful tools and resources. Symptom Tracker Help your doctor manage your symptoms. Take notes of any changes you notice when you start taking RYTARY. Taking RYTARY Reminders Keep this booklet of reminders of how to take your RYTARY dose. RYTARY Co-Pay Savings Card Rx • Pay no more than $25 on your RYTARY prescription with private insurance.* • No additional costs if you’re prescribed a second dosage strength.* RYTARY.com website Visit RYTARY.com for more information about your treatment and living with Parkinson’s disease. * p to $100 maximum benefit. See terms, conditions, and eligibility U criteria inside the RYTARY Co-Pay Savings Card brochure. Important Safety Information 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. 22 E V ERY MOMENT COUNT S Please see additional Important Safety Information throughout, complete Important Safety Information on pages 12-14, and Full Prescribing Information at RYTARY.com. 48.75 mg / 195 mg • 61.25 mg / 245 mg 23 Your time matters. Make the most of it. V ISIT RYTARY.C O M Important Safety Information 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. RYTARY and MyRYTARY are trademarks of Impax Laboratories, Inc. ©2015 Impax Pharmaceuticals, a division of Impax Laboratories, Inc. All rights reserved. PP-PAT-RYT-US-0015 04/15 48.75 mg / 195 mg • 61.25 mg / 245 mg