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COPAXONE® FAQs


Below you’ll find some of the most frequently asked questions—and a few that are not so common—concerning COPAXONE®. For the answers, click on a question or select the Show All button to see all 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 conducted.1

COPAXONE® comes in pre-filled, 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 routine, injecting COPAXONE® should take you less than one minute each day.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 the effects of multiple sclerosis.3–5

COPAXONE® is believed to work with your immune system to change the way it reacts to MS by both preventing harmful immune cells from developing and simultaneously stimulating the production of beneficial immune cells in your body. These “good” COPAXONE®-activated cells then enter the CNS and help reduce inflammation and damage at the site of lesions.3
How does COPAXONE® affect my immune system?
As a person living with multiple sclerosis, it's especially important to be knowledgeable about the immune system—your body's natural system of defenses. Your immune system plays a key role in your disease and your treatment choice, and is an essential element in your overall health. Each of the approved treatments for relapsing-remitting multiple sclerosis (RRMS) affects your immune system in a different way. COPAXONE® works with your immune system to fight MS.

COPAXONE® is believed to change the way your immune system reacts to MS by stimulating a protective immune response in your body. COPAXONE® prevents the development of harmful immune cells and stimulates the production of beneficial immune cells. These "good" COPAXONE®-activated cells then enter the central nervous system (CNS) to help reduce inflammation and damage at the site of lesions.3

In theory, COPAXONE® could interfere with immune function. However, there is no evidence that COPAXONE® undermines the body's tumor surveillance or its defenses against infection, but there has not been a systematic evaluation of this risk.
How effective is COPAXONE®?
COPAXONE® has been proven effective in 3 Class I clinical trials,6–8 which meet the highest standards of the American Academy of Neurology.9 In combination, these studies demonstrated that COPAXONE® effectively reduced relapses6–8 and new lesions as measured by magnetic resonance imaging (MRI).8

The effectiveness of COPAXONE® has also been proven in the longest continuous, open-label, prospective study ever conducted of people with relapsing-remitting multiple sclerosis (RRMS)—15 years and counting.1,2 Click here to learn more.

COPAXONE® is indicated for the reduction of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
Is COPAXONE® safe?
COPAXONE® has been proven to be safe in the longest follow-up study of people with relapsing-remitting multiple sclerosis ever conducted—15 years and counting.1-2

COPAXONE® does not have any warnings for safety concerns such as serious infections. COPAXONE® has NO required or recommended initial-dose or routine monitoring to make sure that your therapy continues to be safe for you. With COPAXONE®, there are no known drug interactions, although such interactions have not been fully evaluated.10

Click here to find out more.
What are the side effects associated with COPAXONE®?
Because you are looking for a therapy that will continue to work for you through the years, it's important to consider how your therapy will make you feel. COPAXONE® is not associated with flu-like symptoms (when compared to placebo) or treatment-related fatigue and depression—the kind of side effects that can interfere with daily activities.10

As with other injectable relapsing-remitting multiple sclerosis therapies, one common side effect with COPAXONE® is injection site reactions. Injection site reactions happen in the area where you've been injecting and can include redness, swelling, itching, pain, or a lump.

You can take steps to help reduce injection site reactions by practicing good injection techniques, such as changing the area of your body that you inject each day.

You can also talk to your doctor or call Shared Solutions® at 1-800-887-8100 if you would like help with your injection technique.

Additional safety information about COPAXONE®

  • The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. 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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch, or call 1-800-FDA-1088.
Why is it important to take my COPAXONE® every day?
Injecting every day certainly has its challenges, but we know from our long-term data that the benefits of a daily injection (known as compliance) can outweigh these challenges.1,6

The efficacy of the daily dose of COPAXONE® was proven in multiple studies including the 2 well-controlled pivotal trials.2,6,8 Teva Neuroscience, Inc., also analyzed a database of more than 800 people who were prescribed COPAXONE® and found the more compliant people were when taking their COPAXONE® therapy, the lower their possibility of having a relapse. If you take your therapy as prescribed, you may have similar results.

Click here for more reasons to feel motivated about taking your COPAXONE® every day, and to empower you to keep on taking it for the long term.

Shared Solutions® also offers a free daily planner to help you keep track of your daily injections and medical appointments. An online version of the daily planner with a built-in injection site tracker is available here.
What do I do if I miss a dose of my COPAXONE® therapy?
Even the most diligent person can forget a dose from time to time, especially when their normal routine has been disrupted for some reason.

If you miss a dose, you should take it as soon as you remember. If, however,  by the time you remember it is closer to the time of your next dose, skip the missed dose and resume your usual dosing schedule.

If you have any questions about missing a dose, contact Shared Solutions® at 1-800-887-8100 for assistance.

Shared Solutions® also offers a free daily planner to help you keep track of injections and medical appointments. An online version of the daily planner with a built-in injection site tracker is available here.
Can I get help with injecting COPAXONE®?
If you find the prospect of injecting yourself to be intimidating, you are not alone. Many first-time COPAXONE® users feel a little nervous about giving themselves an injection. Shared Solutions® is here to help.

If you have never injected COPAXONE® before, or would like to brush up on your injection techniques, you can call Shared Solutions® at 1-800-887-8100 and set up an in-home visit from a nurse who will provide you with personal injection training.

For refresher tips on injecting techniques you can speak with your doctor or take advantage of the step-by-step instructions on this Web site. Click here for help with 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 allows you to 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.
What can I do to help manage injection site reactions?
Injection site reactions (ISRs) are a common side effect associated with COPAXONE®. One of the most effective ways to avoid ISRs 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.
What should I do if I have an immediate postinjection reaction?
Some COPAXONE® users experience a short-term reaction right after injecting. Symptoms may include chest tightness or pain with a fluttery or rapid heartbeat and trouble breathing.

This type of reaction should go away in several minutes and should not cause further problems. If this happens to you, it is important to:
 
  • Stay calm
  • Sit down
  • Keep your head upright
  • Breathe slowly
 
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.

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.
Can I take a flu shot or other vaccine if I'm using COPAXONE®?
While we don't have any studies describing the use of COPAXONE® in combination with the influenza vaccine or other vaccines, studies do show that the following vaccines are safe for people with multiple sclerosis:11

 
  • Influenza (flu)
  • Hepatitis B
  • Measles
  • Rubella (German measles)
  • Tetanus
  • Diphtheria/tetanus
  • Varicella (chicken pox)

Even though the following vaccines do not have published studies addressing their safety in MS, it is recommended that people who meet the Centers for Disease Control and Prevention (CDC) criteria be given them:11

  • Pneumonia
  • Meningitis
  • Typhoid
  • Polio
  • Hepatitis A
  • Human papillomavirus
  • Pertussis
The National Multiple Sclerosis Society has more information at www.nationalmssociety.org/living-with-multiple-sclerosis/healthy-living/vaccinations/index.aspx. In addition, the CDC has information at www.cdc.gov/vaccines.

People experiencing a relapse affecting their abililty to carry out daily activities should defer any vaccination until 4 to 6 weeks after the onset of relapse.10 As always, you should discuss the use of any medication, including vaccinations, with your doctor prior to use.
Am I at greater risk for swine flu if I have MS or if I use COPAXONE®?
Since swine flu has been a point of international focus,12 many in the MS community have expressed concern about possible complications arising for people with MS.

There are no data, however, to suggest that people living with MS or taking COPAXONE® are at any greater or lesser risk of contracting the virus than the general population.

As always, you should discuss the use of any medication, including vaccinations, with your doctor prior to use.
Will COPAXONE® interact with any other medications I am currently taking?
There are no known drug interactions with COPAXONE®.10

While interactions between COPAXONE® therapy and all other drugs have not been fully evaluated, existing trial results do not suggest any significant interactions of COPAXONE® with therapies commonly used in multiple sclerosis patients, including the concurrent use of corticosteroids.

As always, you should discuss the use of any medication, including vaccinations, with your doctor prior to use.
Can I drink alcohol while I am taking COPAXONE®?
Check with your doctor or pharmacist for potential interactions between alcohol and any prescription medications, over-the-counter products, supplements, herbs, and vitamins that you are taking.
Are there foods I should avoid while taking COPAXONE®?
There are no known food interactions with COPAXONE®.2 While there haven't been any studies specific to food interactions with COPAXONE®, during clinical trials, participants continued their normal diets, and no food interactions of clinical significance were observed.
What does COPAXONE® do for spinal lesions?
Unfortunately, there are insufficient data regarding the impact of COPAXONE® on spinal lesions. Ask your doctor for additional information.
Do COPAXONE® Pre-Filled Syringes expire?
Yes they do, and it is something you should be aware of. The expiration date is printed on each syringe as well as on every box.
How should I store my COPAXONE®?
The best place to store your COPAXONE® is in the refrigerator at a temperature ranging from 36ºF to 46ºF (2ºC to 8ºC). COPAXONE® can also be stored safely at room temperature (59ºF to 86ºF/15ºC to 30ºC) for up to one month, which allows for a great degree of flexibility if you plan to do any traveling.

You´ll also want to transport your COPAXONE® in a thermal travel bag to protect it from extreme temperatures and prevent it from overheating or freezing.
 
Remember, never administer COPAXONE® if it has frozen, gets too hot, or appears cloudy. If these conditions should occur, dispose of your COPAXONE® in a proper container. If in doubt, you can call Shared Solutions® at 1-800-887-8100 to help you assess the risk.

When not in use, store COPAXONE® Pre-Filled Syringes in a place that's protected from light.
Once I've taken COPAXONE® out of the refrigerator, can I put it back?
That depends. Yes, if you've kept track and know that the total number of days that your COPAXONE® has been at room temperature is under 30. But, if the COPAXONE® Pre-Filled Syringe has been unrefrigerated for 1 month or more, do not put it back in the refrigerator and do not use it. If you aren't sure, call Shared Solutions® at 1-800-887-8100 to help you assess the risk.
How do I know if my COPAXONE® has gone above or below room temperature?
When you take COPAXONE® out of your house, you should always be mindful of temperatures in places without heating or cooling systems, such as parked cars, or in questionably regulated conditions, such as hotel refrigerators.

It is a good idea to carry a thermometer to measure temperature when traveling, and also to transport your COPAXONE® in a thermal travel bag to protect it from extreme temperatures and prevent it from overheating or freezing. If your COPAXONE® has been unprotected in an extremely hot environment, you should dispose of it. When in doubt, you can always call Shared Solutions® at 1-800-887-8100 to help you assess the risk.
Can COPAXONE® Pre-Filled Syringes be frozen?
No. If your COPAXONE® freezes, do not use it. You should make sure it is discarded in a proper container, and use a new COPAXONE® Pre-Filled Syringe.
Are there any special tips for traveling with COPAXONE® Pre-Filled Syringes?
Traveling with COPAXONE® is convenient, since it can be stored unrefrigerated for up to 1 month. 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.
Will the airport security X-ray affect my COPAXONE®?
It is safe to take your COPAXONE® through airport security. We are not aware of any effect that X-ray, magnetic, or other metal detectors have on COPAXONE®.
Why is the dosage of COPAXONE® the same for a 120-lb person as it is for a 220-lb person?
Like many other medications, COPAXONE® is prescribed in a fixed dose without regard to body weight. The dosages of some medications need to be adjusted according to body weight to avoid a toxic effect or to achieve a therapeutic drug concentration in the bloodstream, but COPAXONE® dosage does not need to be adjusted in this way. Clinical trials with COPAXONE® demonstrated the safety and efficacy of a fixed dosage of 20 mg/day, independent of body weight. COPAXONE® side effects are not known to be dose-related.
Can I take COPAXONE® if I am trying to get pregnant or if I become pregnant?
The decision to have a child is a big one, and how your MS therapy will impact your pregnancy is also important to consider.

COPAXONE® is rated pregnancy category B,10 which means that reproductive studies performed in animals have revealed no evidence of harm to the fetus due to COPAXONE®.

Animal reproductive studies are not always predictive of human response, and as there have been no controlled studies of COPAXONE® in pregnant women, you should consult your doctor about planning a pregnancy or if you become pregnant while taking COPAXONE®.




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References:
1. Ford C, Goodman AD, Johnson K, et al. Mult Scler. 2010;16(3):342-350. 2. Data on file. Teva Neuroscience, Inc. 3. Miller A, Shapiro S, Gershtein R, et al. J Neuroimmunol. 1998;92(1-2):113-121. 4. Ziemssen T, Kümpfel T, Klinkert WE, Neuhaus O, Hohlfeld R. Brain. 2002;125(Pt11):2381-2391. 5. Chen M, Valenzuela RM, Dhib-Jalbut S. J Neurol Sci. 2003;215(1-2):37-44. 6. Johnson KP, Brooks BR, Cohen JA, et al. Neurology. 1995;45(7):1268-1276. 7. Bornstein MB, Miller A, Slagle S, et al. N Engl J Med. 1987;317(7):408-414. 8. Comi G, Filippi M, Wolinsky JS. Ann Neurol. 2001;49(3):290-297. 9. Goodin DS, Frohman EM, Garmany GP, et al. Neurology. 2002;58(2):169-178. 10. COPAXONE® prescribing information. Teva Pharmaceutical Industries Ltd. 11. Vaccinations. National Multiple Sclerosis Society Web site. http://www.nationalmssociety.org/living-with-multiple-sclerosis/healthy-living/vaccinations/index.aspx. Accessed September 15, 2010. 12. 2009 H1N1 Flu and You. CDC Web site. http://www.cdc.gov/h1n1flu/qa.htm. Last updated August 11, 2010. Accessed September 23, 2010.

COP110006401/111825
  • COPAXONE® (glatiramer acetate injection) is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

Important Safety Information About COPAXONE®

  • The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. 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.

    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.

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*IMS Health National Prescription Audit, May 2011. Data is proprietary to IMS Health.
 

COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd. Shared Solutions® is a registered trademark of Teva Neuroscience, Inc. autoject® 2 for glass syringe is a registered trademark of Owen Mumford, Ltd. COPAXONE CO-PAY SOLUTIONS™ is a trademark of Teva Pharmaceutical Industries Ltd. © 2011, Teva Neuroscience, Inc. All Rights Reserved. This site is intended for US residents only.

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