Sun Pharma’s Glatiramer Acetate Injection is FDA approved and therapeutically equivalent to Copaxone®, indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It is not known if Glatiramer Acetate injection is safe and effective in children under 18 years of age.
How-to Guide
Learn how to use the GripMate™ Autoinjector safely and confidently.
GLATIRAMER ACETATE injection, for subcutaneous use
Glatiramer acetate injection for subcutaneous use is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
It is not known if glatiramer acetate injection is safe and effective in children under 18 years of age.
Glatiramer acetate injection is given by injection under your skin. For detailed instructions on how to use glatiramer acetate injection, see the Instructions for Use.
Do not inject glatiramer acetate injection in your veins (intravenously).
Do not re-use your glatiramer acetate injection prefilled syringes.
Do not share your glatiramer acetate injection prefilled syringes with another person. You may give another person an infection or get an infection from them.
Allergic reactions/immediate post-injection reactions: Serious allergic reactions (anaphylactic reactions) that may be life-threatening or lead to death may happen any time after you start using glatiramer acetate injection. These reactions may happen right after your first dose up to years after starting treatment. Many reactions have happened within one hour of using glatiramer acetate injection.
Stop using glatiramer acetate injection and get emergency help right away if you have: widespread rash; swelling of the face, eyelids, lips, mouth, throat, or tongue; sudden shortness of breath, difficulty breathing, or wheezing; uncontrolled shaking (convulsions); trouble swallowing or speaking; fainting, feeling dizzy or faint.
Possible serious side effects: Glatiramer acetate injection may cause:
Chest Pain: You can have chest pain as part of an immediate post-injection reaction or by itself. This type of chest pain usually lasts a few minutes and can begin around one month after you start using glatiramer acetate injection. Call your healthcare provider right away if you have chest pain while using glatiramer acetate injection.
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 glatiramer acetate injection. You can reduce your chance of developing these problems by following your healthcare provider’s instructions for how to use glatiramer acetate injection or choosing a different injection area each time you use glatiramer acetate injection.
Liver problems: Liver problems, including liver failure, can occur with glatiramer acetate injection.
Adverse reactions: The most common adverse reactions from glatiramer acetate injection were injection site reactions, vasodilatation, rash, shortness of breath, dyspnea, and chest pain.
Before you use glatiramer acetate injection, tell your healthcare provider about all of your medical conditions, including if you are pregnant or plan to become pregnant or are breastfeeding. Your healthcare provider will advise if you should take glatiramer acetate injection during your pregnancy or while breastfeeding.
Tell your healthcare provider about all the medicines you take. Glatiramer acetate injection may affect the way other medicines work, and other medicines may affect how glatiramer acetate injection works.
How to take glatiramer acetate injection: Your healthcare provider will tell you how much glatiramer acetate injection to use and when to use it. Use glatiramer acetate injection exactly as your healthcare provider tells you to use it. Talk with your healthcare provider about the injection areas that are best for you.
You should receive your first dose of glatiramer acetate injection with a healthcare provider or nurse present. They will teach you how to give your injections.
Check with your healthcare provider when you fill or refill your medicine to make sure the autoinjector you have is meant to be used with your glatiramer acetate product. Not all optional autoinjectors are meant to be used with all glatiramer acetate products.
Store glatiramer acetate injection in the refrigerator between 36°F to 46°F (2°C to 8°C). When you are not able to refrigerate glatiramer acetate injection, you may store it for up to 1 month at room temperature between 59°F to 86°F (15°C to 30°C). Before use, allow the solution to warm to room temperature.
Protect glatiramer acetate injection from light or high temperature. Do not freeze glatiramer acetate injection syringes. If a syringe freezes, throw it away in a sharps disposal container.
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries Inc at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If the GripMate™ Autoinjector is broken, damaged, or you have any other concerns, email DrugSafety.USoperations@sunpharma.com or call 1-800-818-4555 for more information.
