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FAQs about COPAXONE®

About COPAXONE®: Frequently Asked Questions (FAQs)

Click on the questions below to see the answers.

What is COPAXONE® therapy?

COPAXONE® is a unique therapy that has been proven effective and safe in the longest continuous, open-label, prospective study of relapsing-remitting multiple sclerosis (RRMS) ever.1 COPAXONE® comes in prefilled, ready-to-use syringes and is delivered just below the skin with a small needle—similar to the way millions of people living with diabetes inject insulin. Once it becomes part of your daily routine, the average amount of time it takes to inject COPAXONE® is less than a minute.2

How does COPAXONE® work in my body?

COPAXONE® is a unique therapy that is thought to work both outside and inside the central nervous system (CNS) to fight damage to the nervous system.3-5 Click here to read more about the effects of multiple sclerosis.

COPAXONE® is believed to change the way your immune system reacts to MS by preventing harmful cells from developing and by stimulating beneficial cells in your body. These “good” COPAXONE®-activated cells then enter the CNS and help reduce damage at the site of lesions.3

How effective is COPAXONE®?

COPAXONE® has been proven effective in 3 “Class I” clinical trials,6-8 which are studies that meet the highest standards of the American Academy of Neurology.9 In combination, these studies showed that COPAXONE® effectively reduced relapses6-8 and new lesions as measured by MRI.8 And, the effectiveness of COPAXONE® has been proven in the longest continuous, open-label, prospective study ever of people with relapsing-remitting multiple sclerosis—over 10 years and counting.1,2 Click here to learn more.

COPAXONE® is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis.

Is COPAXONE® safe?

COPAXONE® has been determined to be safe in the longest follow-up of relapsing-remitting multiple sclerosis patients ever—over 10 years and counting! 1,2,6 You are not required to have routine blood tests and monitoring to ensure that your therapy continues to be safe for you.10 And, COPAXONE® is not associated with serious safety concerns.10 COPAXONE® has a track record you can count on for the long term.1,2,6 Click here to find out more.

COPAXONE® is the only injectable therapy not associated with flu-like symptoms, increases in MS-related fatigue, or depression (when compared with placebo)—side effects that can interfere with your daily activities.10-13

What are the side effects associated with COPAXONE®?

The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These reactions are usually mild and seldom require professional treatment. Be sure to tell your doctor about any side effects.

Some patients report a short-term reaction right after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes of an injection, last about 15 minutes, and go away by themselves without further problems.

A permanent indentation under the skin at the injection site may occur, due to a local destruction of fat tissue. Be sure to follow proper injection technique and inform your doctor of any skin changes.

After you inject COPAXONE®, call your doctor right away if you develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, severe pain at the injection site or other uncomfortable changes in your general health. Do not give yourself any more injections until your doctor tells you to begin again.

Why is it important to take my COPAXONE® every day?

Taking COPAXONE® every day as prescribed (also known as being compliant) is beneficial to the management of your MS.

The daily dose of COPAXONE® was proven in multiple studies including the 2 well-controlled pivotal trials.2,6,8 We know COPAXONE® is effective in reducing relapses and stabilizing EDSS based on a wealth of evidence in numerous short and long-term studies, as well as thousands of patients taking COPAXONE® every day.1,2,6-8,14-17

Now we have information that further reinforces the importance of taking your COPAXONE® each and every day. Teva Neuroscience, Inc., analyzed a database of more than 800 people who were prescribed COPAXONE® and found that the more compliant people were when taking their COPAXONE® therapy, the lower their possibility of having a relapse.18

If you take your therapy as prescribed, you may have similar results. So, now there are even more reasons to feel motivated about taking your COPAXONE® every day…and to be empowered to keep on taking it for the long term.

Can I get help with injecting COPAXONE®?

If you have never injected COPAXONE® before, or would like to brush up on your injection techniques, be sure to call Shared Solutions® at 1-800-887-8100 and set up a visit from a nurse who will provide in-home injection training. For refresher tips, take advantage of the step-by-step online instructions on this Web site. You will find instructions for both the autoject®2 for glass syringe and the COPAXONE® Pre-Filled Syringe.

Is there a device to help with injecting COPAXONE®?

COPAXONE® can be administered with the autoject®2 for glass syringe, an automatic injection device that’s available by prescription. This device hides the needle and helps you inject COPAXONE® with the touch of a button.

What is the autoject®2 for glass syringe?

The autoject®2 for glass syringe is an automatic injection device that’s available by prescription. This device, which completely hides the needle throughout the injection, holds the COPAXONE® Pre-Filled syringe, and delivers COPAXONE® therapy at the touch of a button to help you get to those hard-to-reach areas of your body.

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What can I do to help manage injection site reactions?

One of the most effective ways to avoid injection site reactions and keep your skin healthy is to rotate your injection areas each day. You can learn more about proper injection techniques and tips by clicking here.

For people on COPAXONE®, Shared Solutions® can send you a free daily planner to keep track of injections and medical appointments. Also, if you think it might be beneficial, brush up on proper injection techniques by talking with your doctor or by calling Shared Solutions® at 1-800-887-8100.

What should I do if I have an immediate postinjection reaction?

A short-term reaction—which may include chest tightness or pain, with a fluttery or rapid heartbeat, and trouble breathing—can happen to anyone taking COPAXONE®.

This type of reaction, which can occur right after injecting, should go away in several minutes and not cause further problems. But if it occurs, it is important to:

  • Try to relax and not feel scared
  • Sit down
  • Keep your head upright
  • Breathe slowly

Important: If the reaction doesn’t end in a few minutes or if you have different symptoms (such as swelling of the face, tongue, or eyes; difficulty swallowing; or wheezing) seek medical attention immediately.

After the reaction is over, call your health care professional as soon as possible, and do not give yourself another injection until your doctor tells you to begin again.

How do I properly store my COPAXONE® therapy?

Keep your monthly supply of COPAXONE® Pre-Filled Syringes refrigerated between 36ºF and 46ºF (2ºC-8ºC). COPAXONE® Pre-Filled Syringes may be stored at room temperature between 59ºF and 86ºF (15ºC-30ºC) for up to one month. You’ll want to transport your COPAXONE® in a thermal travel bag to protect it from extreme temperatures, which may cause overheating or freezing.

Never administer COPAXONE® if it gets too hot, becomes frozen, or appears cloudy. If these conditions should occur, do not use your COPAXONE® Pre-Filled Syringes and dispose of them in a proper container. When you aren’t injecting, store COPAXONE® Pre-Filled Syringes in a place that’s protected from light.

As a general rule, we recommend that you keep your COPAXONE® in the refrigerator as part of your regular routine, but the one-month storage time offers you added flexibility during travel or special circumstances.

How can I take my COPAXONE® when I go on vacation?

Traveling with COPAXONE® is convenient because it does not have to be refrigerated for up to one month. So, you can easily travel with your COPAXONE® as long as it is kept at room temperature. For more information about traveling with COPAXONE® click here.

What do I do if I miss a dose of my COPAXONE® therapy?

If you miss a dose, use it as soon as you remember. If it is closer to the time of the next dose, skip the missed dose and resume your usual dosing schedule. Avoid giving 2 injections in the same 12-hour period of time. If you have any questions about missing a dose, feel free to contact Shared Solutions® at 1-800-887-8100 for assistance.

What should I do if I get pregnant while taking COPAXONE®?

You should speak to your doctor if you plan to or have become pregnant while taking COPAXONE® therapy.


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References:
  1. Ford C, Johnson K, Kachuck N, et al. Presented at: World Congress on Treatment and Research in Multiple Sclerosis; September 17-20, 2008; Montreal, Quebec, Canada. P44.
  2. Data on file. Teva Neuroscience, Inc.
  3. Miller A, Shapiro S, Gershtein R, et al. J Neuroimmunol. 1998;92:113-121.
  4. Ziemssen T, Kumpfel T, Klinkert W, et al. Brain. 2002;125:2381-2391.
  5. Chen M, Valenzuela RM, Dhib-Jalbut S. J Neurol Sciences. 2003;215:37-44.
  6. Johnson KP, Brooks BR, Cohen JA, et al. Neurology. 1995;45:1268-1276.
  7. Bornstein MB, Miller A, Slagle S, et al. N Engl J Med. 1987;317:408-414.
  8. Comi G, Filippi M, Wolinsky JS, et al. Ann Neurol. 2001;49:290-297.
  9. Goodin DS, Frohman EM, Garmany GP, et al. Neurology. 2002;58:169-178.
  10. COPAXONE® prescribing information, 11/07. Teva Neuroscience, Inc.
  11. Avonex® prescribing information, 11/06. Biogen Idec.
  12. Betaseron® prescribing information, 10/07. Bayer HealthCare Pharmaceuticals, Inc.
  13. Rebif® prescribing information, 4/08. EMD Serono, Inc.
  14. Mikol DD, Barkhof F, Chang P, on behalf of the REGARD study group [published online ahead of print September 10, 2008]. Lancet Neurol.
  15. BEYOND press release. Bayer HealthCare AG. October 29, 2007.
  16. Wolansky L, Cook S, Skurnick J, et al. Presented at: 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis; October 11-14, 2007; Prague, Czech Republic. P206.
  17. Khan O, Mackenzie M, Bao F, et al. AAN 2008.PO8.173
  18. Castelli-Haley J, Oleen-Burkey MA, Lage MJ. Poster presented at: 10th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research; October 20-23, 2007; Dublin, Ireland.