FOR ADULTS WITH MS TAKING THE NEXT STEP AMPYRA TREATMENT GUIDE walking better matters See the Patient Medication Guide below.
About AMPYRA (dalfampridine) Extended release tablets How is AMPYRA different? AMPYRA is not a disease-modifying treatment (DMT). It is a symptom-based treatment designed to improve walking in people with MS. DMTs are not indicated to improve walking in people with MS. AMPYRA can be taken with or without a DMT. What is AMPYRA? AMPYRA, an oral medication, is the only treatment shown to improve walking in people with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. 2 Do not take AMPYRA if you have ever had a seizure, or have certain types of kidney problems, or are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA. For more information, see the Patient Medication Guide below. 3
How does AMPYRA (dalfampridine) work? Healthy Nerve Nerve Signal Myelin In healthy nerves, signals travel over myelin, which is a protective layer that surrounds nerves. Damaged Nerve Weakened Signal AMPYRA works differently than DMTs Disease-modifying treatments (DMTs) slow down the progression of multiple sclerosis (MS). AMPYRA is not a DMT. It works differently to improve your walking, as shown in these illustrations. The exact process by which AMPYRA works is not fully understood. However, in preclinical studies, AMPYRA was shown to enhance message conduction in damaged nerve fibers. It is not known if AMPYRA is safe and effective in children less than 18 years of age. MS breaks down myelin. This damage to the myelin affects the nerve s ability to conduct signals. It can also lead to symptoms such as walking difficulties. AMPYRA Effect Strengthened Signal With AMPYRA AMPYRA may help strengthen nerve signals, to coordinate walking. 4 5
What can I expect with AMPYRA (dalfampridine)? AMPYRA is indicated to improve walking This was demonstrated by an increase in walking speed. In two pivotal trials, 35% and 43% of patients taking AMPYRA responded to treatment vs. 8% and 9% of patients taking placebo (a sugar pill). Some patients experience improvement in their walking ability within a couple of weeks. Others notice improvement up to six weeks after starting. Improvements in walking were meaningful People who walked faster in the AMPYRA clinical trials, regardless of whether they were taking AMPYRA or placebo, also reported improvements in their walking-related activities. These improvements were based on the 12-item Multiple Sclerosis Walking Scale (MSWS-12),* a self-assessment tool used by patients to rate the impact of MS on their walking. Not everyone responds to AMPYRA. Individual results may vary. * MSWS-12 activities include standing, maintaining balance, ability to run, climbing stairs, need for support, walking distances, moving around the home, effort needed to walk, concentration needed to walk, ability to walk, walking speed, and gait. 6 7
How to take AMPYRA (dalfampridine) Take AMPYRA as prescribed by your doctor 12 HOURS APART Take AMPYRA exactly as your doctor tells you to take it. Take one tablet of AMPYRA two times each day about 12 hours apart. Do not take more than two tablets of AMPYRA in a 24-hour period. AMPYRA TABLET ACTUAL SIZE TAKE TABLET WHOLE Take AMPYRA tablets whole. Do not break, crush, chew or dissolve AMPYRA tablets. If you cannot swallow AMPYRA tablets whole, tell your doctor. AMPYRA is released slowly over time. If the tablet is broken, the medicine may be released too quickly. AMPYRA can be taken with or without food. AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same. 8 9
AMPYRA (dalfampridine) resources and patient support Resources to help you track your progress Once you ve taken your first step with AMPYRA, we want to make sure that you have all the support you need to stay on track with treatment. The AMPYRA Progress Tracker and Walking Journal are convenient for keeping your healthcare team up-to-date and informed about your progress. Find them at AMPYRA.com AMPYRA Patient Support Services (APSS): Your connection to cost and coverage APSS is on the line and online to provide answers and assistance when you need them. Their primary mission is to make AMPYRA more affordable and to ensure that you have resources and support that are second to none. You can reach APSS at 888-881-1918, Monday through Friday, from 8 am to 8 pm eastern time. The most common side effects of AMPYRA include urinary tract infection, trouble sleeping, dizziness, headache, nausea, weakness, back pain, and problems with balance. 910 10 11
Important Safety Information AMPYRA (dalfampridine) is indicated as a treatment to improve walking in patients with MS. This was demonstrated by an increase in walking speed. In two pivotal trials, 35% and 43% of patients taking AMPYRA responded to treatment vs 8% and 9% of patients taking placebo. Talk to your doctor to see if AMPYRA may be right for you. Important Safety Information Do not take AMPYRA if you have ever had a seizure, have certain types of kidney problems, or are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA. Take AMPYRA exactly as prescribed by your doctor. Before taking AMPYRA, tell your doctor if you have kidney problems or any other medical conditions are taking compounded 4-aminopyridine are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby. are breast-feeding or plan to breast-feed. It is not known if AMPYRA passes into your breast milk. You and your doctor should decide if you will take AMPYRA or breast-feed. You should not do both. are taking any other medicines Stop taking AMPYRA and call your doctor right away if you have a seizure while taking AMPYRA. You could have a seizure even if you never had a seizure before. Your chance of having a seizure is higher if you take too much AMPYRA or if your kidneys have a mild decrease of function, which is common after age 50. Your doctor may do a blood test to check how well your kidneys are working before you start AMPYRA. AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same. AMPYRA may cause serious side effects, including severe allergic reactions. Stop taking AMPYRA and call your doctor right away or get emergency medical help if you have shortness of breath or trouble breathing, swelling of your throat or tongue, or hives; kidney or bladder infections. The most common adverse events for AMPYRA in MS patients were urinary tract infection, trouble sleeping, dizziness, headache, nausea, weakness, back pain, and problems with balance. 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 Patient Medication Guide below. 12 13
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AMPYRA, ACORDA THERAPEUTICS and the stylized ACORDA THERAPEUTICS logo are registered trademarks of Acorda Therapeutics, Inc. AMPYRA is marketed by Acorda Therapeutics, Inc. and manufactured under license from Alkermes Pharma Ireland Limited (APIL), Ireland. The stylized path logo and the stylized Acorda logo are trademarks of Acorda Therapeutics, Inc. 2014 Acorda Therapeutics, Inc. All rights reserved. 04/14 AMP3038