Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64Patient Information Glatopa® (glatiramer acetate injection) for Subcutaneous Use Read this Patient Information before you start using Glatopa and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is Glatopa? Glatopa is prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS). It is not known if Glatopa is safe and effective in children under 18 years of age. Glatopa is supplied as a 1 mL single dose glass syringe with attached 1/2 inch length and 29 gauge needle. Who should not use Glatopa? • Do not use Glatopa if you are allergic to glatiramer acetate or mannitol. What should I tell my doctor before using Glatopa? Before you use Glatopa, tell your doctor if you: • are pregnant or plan to become pregnant. It is not known if glatiramer acetate will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if glatiramer acetate passes into your breast milk. Talk to your doctor about the best way to feed your baby while using Glatopa. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Glatopa may affect the way other medicines work, and other medicines may affect how glatiramer acetate works. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine. How should I use Glatopa? • For detailed instructions, visit www.glatopa.com for complete information on how to use Glatopa. • Your doctor will tell you how much Glatopa to use and when to use it. • Glatopa is given by injection under your skin (subcutaneously). • Use Glatopa exactly as your doctor tells you to use it. • Since every body type is different, talk with your doctor about the injection areas that are best for you. • You should receive your first dose of Glatopa with a doctor or nurse present. This might be at your doctor’s office or with a visiting home health nurse who will teach you how to give your Glatopa injections. What are the possible side effects of Glatopa? Glatopa may cause serious side effects, including: •Post-Injection Reactions. Serious side effects may happen right after you inject Glatopa at any time during your course of treatment. Call your doctor right away if you have any of these post-injection reaction symptoms including: o redness to your cheeks or other parts of the body (flushing) o chest pain o fast heart beat o anxiety o breathing problems or tightness in your throat o swelling, rash, hives, or itching If you have symptoms of a post-injection reaction, do not give yourself more injections until a doctor tells you to. •Chest Pain. You can have chest pain as part of a post-injection reaction or by itself. This type of chest pain usually lasts a few minutes and can begin around 1 month after you start using Glatopa. Call your doctor right away if you have chest pain while using Glatopa. •Damage to your skin. Damage to the fatty tissue just under your skin's surface (lipoatrophy) and, rarely, death of your skin tissue (necrosis) can happen when you use Glatopa. Damage to the fatty tissue under your skin can cause a "dent" at the injection site that may not go away. You can reduce your chance of developing these problems by: o following your doctor's instructions for how to use Glatopa. o choosing a different injection area each time you use Glatopa. The most common side effects of Glatopa include: • skin problems at your injection site including: o redness o pain o swelling o itching o lumps • rash • shortness of breath • flushing (vasodilation) Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Glatopa. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Glatopa? • Store Glatopa in a refrigerator between 36°F to 46°F (2°C to 8°C). • When you are not able to refrigerate Glatopa, you may store it for up to 1 month at room temperature between 59°F to 86°F (15°C to 30°C). • Protect Glatopa from light or high temperature. • Do not freeze Glatopa syringes. If a syringe freezes, throw it away in a sharps disposable container. Keep Glatopa and all medicines out of the reach of children. General information about the safe and effective use of Glatopa. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Glatopa for a condition for which it was not prescribed. Do not give Glatopa to other people, even if they have the same symptoms as you have. It may harm them. This Patient Information summarizes the most important information about Glatopa. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Glatopa that is written for health professionals. For more information, go to www.glatopa.com or call Sandoz GlatopaCare® at 1-855-452-8672. What are the ingredients in Glatopa? Active ingredient: glatiramer acetate Inactive ingredient: mannitol Marketed By: Sandoz Inc., Princeton, NJ 08540 Distributed By: Sandoz Inc., Princeton, NJ 08540 Product of the USA This brief summary is based on Glatopa FDA-approved patient labeling, revised: 01/2016 Glatopa and GlatopaCare are registered trademarks of Novartis AG. ©2016 Sandoz Inc., a Novartis Division, 100 College Road West, Princeton, NJ 08540. All Rights Reserved. S-GLA-1332880 06/2016