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Copaxone: 7 things you should know

Medically reviewed by Carmen Fookes, BPharm. Last updated on Nov 10, 2020.

1. How it works

  • Copaxone (glatiramer acetate) is a combination of four amino acids that may be used to treat relapsing forms of multiple sclerosis (MS) in adults, such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
  • Experts aren’t sure exactly how Copaxone works in MS but it is thought to modify immune processes that are believed to be responsible for the development of MS. Copaxone contains glatiramer acetate which is a combination of the acetate salts of four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. These amino acids resemble the myelin protein surrounding nerve fibers and are thought to act as a decoy to divert an immune attack away from your myelin. Research has shown that after administration of glatiramer, glatiramer-specific suppressor T-cells are induced and activated in the peripheral nervous system. Although glatiramer is thought to modify the immune system response to MS, it does not appear to modify naturally occurring immune responses, although this has not been systematically evaluated.
  • Copaxone belongs to the class of medicines known as immunostimulants.

2. Upsides

  • Copaxone is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • Research has indicated that Copaxone is generally well tolerated and it has one of the lowest rates of discontinuation because of safety concerns of any medication for MS.
  • Injectable disease-modifying treatments, such as Copaxone but also interferon beta 1a and 1b, tend to only reduce relapse rates by about one-third and all have a similar impact on disease progression.
  • Copaxone is considered a long-term (life-long) treatment and should be administered for as long as it is effective or tolerated.
  • Copaxone has shown to significantly reduce the number of relapses in people with MS. 34 to 56% were relapse-free after two years.
  • Copaxone is available as a generic under the name glatiramer acetate and also Glatopa.

3. Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Injection site reactions, including redness, pain, itching, or lumps; nausea; heart palpitations; chest pain; infection; influenza; back pain; anxiety, shortness of breath; rash; and vasodilation are the most common side effects reported. Increased sweating, cough, gastroenteritis, rhinitis, bronchitis, fever, edema, lymphadenopathy, and vomiting may also occur. Many other adverse reactions have been documented and the 20 mg/mL injection is more likely to cause adverse effects. ln trials, approximately 5% of people taking Copaxone discontinued treatment because of an adverse reaction.
  • Approximately 16% injecting Copaxone 20 mg/mL daily and 2% injecting Copaxone 40 mg/mL three times weekly experience a post-injection reaction that occurs within seconds or minutes (less than one hour) and consists of at least two of the following symptoms: anxiety, chest pain, dyspnea, flushing, palpitations, tachycardia, throat constriction, and urticaria (hives). It usually takes several months of regular dosing before these symptoms develop and any particular patient may experience one or several episodes of these symptoms. Typically, the symptoms are short-lived and do not require treatment; however, there are reports of people with similar symptoms receiving emergency medical care. Experts aren't sure exactly why this cluster of symptoms happens.
  • Transient chest pain is reported by approximately 13% of people injecting Copaxone 20 mg/mL and 2% of people injecting Copaxone 40 mg/mL. While some episodes of chest pain were associated with the post-injection reaction described above, many were not. The pain was short-lived, not associated with any other symptoms, and did not appear to have any clinically significant effects. Some people experienced several episodes and episodes usually began at least 1 month after the initiation of treatment.
  • Approximately 2% of people injecting Copaxone 20mg/mL and 0.5% injecting Copaxone 40mg/mL reported lipoatrophy (loss of fat tissue) at the injection site and, rarely, necrosis. The lipoatrophy is thought to be permanent and there is no known treatment. Advise people injecting Copaxone to follow proper injection technique and to rotate injection sites with each injection.
  • How often Copaxone needs to be given varies depending on its strength. Copaxone 20mg/mL injections are given daily while Copaxone 40mg/mL injections are administered three times per week and at least 48 hours apart. Some people find this need for frequent administration a burden.
  • Copaxone is not recommended for children and young adults younger than 18 years. Its effects have not been studied in seniors.
  • Should not be given to people who have a known hypersensitivity to glatiramer acetate or mannitol.
  • Copaxone can modify the immune response and may interfere with immune functions. There is a possibility that it may increase the risk of infection and possibly cancer; however, there is currently no research to suggest this.
  • Copaxone has been associated with liver damage, including liver failure and hepatitis with jaundice, that has occurred within days or after years of Copaxone administration. Consider discontinuing Copaxone if signs or symptoms of liver damage occur.
  • There is insufficient data to determine the risk of administering Copaxone to pregnant women, and there is no data about its effects on a newborn when breastfeeding.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

4. Bottom Line

Copaxone is a combination of four amino acids that may be given to treat relapsing forms of multiple sclerosis in adults. It has been shown to significantly reduce the number of relapses, but may be associated with injection reactions and transient chest pain. There are two different strengths 20 mg/mL and 40 mg/mL and these have different dosage requirements.

5. Tips

  • Copaxone should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). It may be left out of a refrigerator for up to one month at room temperature 15°C to 30°C (59°F to 86°F), as long as it is not exposed to high temperatures or intense light. Discard Copaxone if it is left unrefrigerated, accidentally frozen, or exposed to heat or extreme light.
  • Keep Copaxone in the refrigerator until you are ready to administer it. Once you are ready to administer it, remove one blister-packaged prefilled syringe from the refrigerated carton and let it stand at room temperature for 20 minutes to allow the solution to warm to room temperature. Inspect the solution in the syringe for particles and discoloration. The solution in the syringe should appear clear, colorless to slightly yellow. If particulate matter or discoloration is observed, discard the syringe.
  • Copaxone is given by subcutaneous injection (under the skin) into your arms, abdomen, hips, or thighs. Rotate injection sites every time you administer Copaxone to avoid lipoatrophy (loss of fat tissue).
  • There are two strengths of Copaxone: 20 mg/mL and 40 mg/mL. These are not interchangeable. Copaxone 20mg/mL is administered once daily, every day, and Copaxone 40mg/ml is administered three times per week (with at least 48 hours between dosages). Rotate the area of skin that you inject into so that you are not injecting into the same area of skin. Do not inject into skin that is red, broken, bruised, or has a rash.
  • Some people experience a post-injection reaction that consists of at least two of the following symptoms: anxiety, chest pain, dyspnea, flushing, palpitations, tachycardia, throat constriction, and urticaria (hives). Talk with your doctor if you experience this.
  • Chest pain after a Copaxone injection is also reasonably common. This is usually transient, does not require treatment, and does not cause any damage. Talk to your doctor if you experience chest pain after injecting Copaxone.
  • The prefilled syringe is for single use only. Discard unused portions.
  • Tell your doctor immediately if you develop any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination. Also report any signs of possible liver damage, such as yellowing of your skin or eyes, swelling of the legs or ankles, itchy skin, dark urine, abdominal pain, or nausea or vomiting.
  • Although Copaxone does not appear to interact with many other medications, it is important to tell your doctor about all the other medications you take, including vitamins and herbs and medications brought from a supermarket.
  • Experts aren't sure what effects Copaxone has on a developing baby so tell your doctor if you are pregnant or plan to become pregnant before you start Copaxone.

6. Response and Effectiveness

  • Copaxone reduces the frequency of relapses, and some studies have reported a delay in the progression of the disease.
  • Copaxone starts working from the first injection; however, its effects may not be obvious for several months. Most people report it takes six to nine months before an effect is noticed. In some people, it may take longer.
  • Copaxone is considered a long-term treatment for MS and it has been available for the treatment of MS for more than ten years.
  • Copaxone significantly reduces the number of relapses in people with MS. The results from two separate trials have reported: 34 to 56% of people taking Copaxone were relapse-free after two years. For those that did relapse, an average of 0.6 to 1.2 relapses in 2 years was reported, compared with 1.7 to 2.4 relapses in 2 years in those who took a placebo. It took an average of 287 to 700 days before people had their first relapse while taking Copaxone, compared to 150 to 198 days in those taking placebo. 78 to 80% showed no disease progression compared to only 52 to 75% administered placebo.
  • In patients older than 60 years, discontinuing Copaxone does not appear to make any difference to relapse rates, physical disability, or depression. The impact of discontinuing treatment in younger patients is uncertain. In younger people, the disease is more inflammatory, and treatment is likely to have more of an impact.
  • Observational studies report that patients with MS who persist in using injectable disease-modifying treatments and adhere to the prescribed timing, dosing, and frequency of medication administration have a lower risk of relapse and a better self-reported quality of life than patients who discontinue or are nonadherent.
  • One study looked at the effects of discontinuing treatment in people who were either on Copaxone or interferon beta-1a. There was no difference in the following outcomes compared to people who remained on treatment: time to clinical relapse, the number of new lesions or inflammatory lesions on MRI, the progression of physical disability, inflammatory events.
  • A 2018 study that evaluated 600 patients with MS who were older than 60 years found no significant differences in disease outcome between those who stopped therapy (178 patients) compared with those who continued treatment. Only 10% restarted medication, and only one relapsed out of those 178 patients who stopped. There were also no differences in outcomes such as walking speed, hand function, or depression.

7. Interactions

There is currently only one documented medication that interacts with Copaxone, according to the product information.

This medication is natalizumab (Tysabri), which may also be given to treat MS or Crohn's disease. Taking these two medications together can increase the risk of reactivation of the JC virus that may result in progressive multifocal leukoencephalopathy (PML). The risk is higher in those with a weak immune system or who are receiving certain medications.

Results from existing clinical trials do not suggest any other significant interactions between Copaxone and other therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days.

You should refer to the prescribing information for Copaxone for any updates or newly noted interactions. Copaxone has not been formally evaluated in combination with interferon beta.

References

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Copaxone only for the indication prescribed.

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