Copaxone® (glatiramer acetate)
Drug identification number (DIN): 02245619
Teva Canada Innovation
Copaxone is a synthetic protein made up of a combination of four amino acids that chemically resemble a component of myelin (the insulating material that protects nerves and helps them work properly). Copaxone induces the production of immune cells that are less damaging to myelin.
Indications and use
Copaxone is indicated for the treatment of:
- people with relapsing-remitting MS who are ambulatory (able to walk) to reduce the frequency of attacks and to reduce the number and volume of active brain lesions identified on MRI.
- people at risk of developing clinically definite MS (CDMS) so as to delay the onset of clinically definite MS, and to decrease the number and volume of active brain lesions and overall disease burden on MRI. Before Copaxone is initiated, people at risk of developing CDMS must have brain lesions on MRI and other possible diagnoses must be ruled out.
Copaxone is contraindicated in people with known hypersensitivity to glatiramer acetate or mannitol.
Administration and dose
Copaxone is self-injected every day under the skin (subcutaneously). Copaxone is available in pre-filled syringes and pre-filled auto-injectors. The recommended dose of Copaxone is 20 mg per day.
Mechanism of action
Copaxone is a mixture of peptides (or small proteins) that resemble a protein in myelin. Copaxone is thought to work by modifying the immune processes that are believed to cause MS.
The most common side effects of Copaxone therapy are injection-site reactions (redness, pain, inflammation, itching, or a lump. A permanent depression under the skin at the injection site may also occur, due to a destruction of fat tissue (lipoatrophy) at that site. Rash and hives, headache and anxiety can also occur.This is not a comprehensive list of all possible side effects of Copaxone.
Please see the Copaxone product monograph for a list of other potentially serious side effects. It is important that those with MS discuss side effects about any medication they are considering with their physician. (*Health Canada, product monograph for Copaxone.)
GA-reactive antibodies are not neutralizing and do not alter the principal immunological effects of GA.
Clinical Trials in Relapsing-Remitting MS
Phase III Trial of Copaxone
In this clinical trial, 251 persons with relapsing-remitting MS were randomized to receive either Copaxone or placebo for 2 years. Study participants treated with Copaxone showed a 29% eduction in relapses compared to placebo.1 European/Canadian MRI StudyThis study examined the effect of Copaxone on disease activity in 239 (continued) persons with relapsing-remitting MS. Patients were monitored by magnetic resonance imaging (MRI). MRI is a powerful tool that provides images of the brain, spinal cord, or other areas of the body. It is often used in MS to identify areas of inflammation. Results of the study showed that treatment with Copaxone was associated with fewer MRI brain lesions than was placebo. The relapse rate was also reduced by one-third with Copaxone compared to placebo.2
Clinical Trials: Single Event Suggestive of MS
PreCISe trial in Clinically Isolated Syndrome (CIS)This study examined whether Copaxone could delay the conversion to clinically definite MS in people who had a first clinical event suggestive of MS (an event involving the optic nerve, brain stem/cerebellum, or spinal cord) and at least two brain lesions on MRI. A total of 481 were treated with Copaxone or placebo for up to 3 years. According to the pre-planned interim analysis, the probability of developing clinically definite MS was 43% with placebo compared to 25% with Copaxone, for an absolute risk reduction of 18% and a relative risk reduction of 45%.3
Much of the cost can be reimbursed through private and group health plans for people who meet the prescribing criteria, and through provincial drug programs for individuals who meet the prescribing criteria. In addition, a program called the Copaxone Assistance Program is available to provide financial help for people with insurance or government program co-payments or deductibles. For more information, contact Shared Solutions at 1-800-283-0034.
Drug support program
Shared Solutions at 1-800-283-0034 or Copaxone.ca
1. Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebocontrolled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology 1995; 45: 1268-1276.
2. Comi G, Filippi M, Wolinsky JS. European/ Canadian multicenter, double-blind, randomized, placebocontrolled study of the effects of glatiramer acetate on magnetic resonance imaging-measured disease activity and burden in patients with relapsing multiple sclerosis. European/ Canadian Glatiramer Acetate Study Group. Ann Neurology 2001; 49: 290-297.
3. Comi G. Treatment with glatiramer acetate delays conversion to clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndromes. Abstract LBS.003. 60th annual meeting of the American Academy of Neurology, Chicago IL, April 12-19, 2008.
Copaxone® is a registered trademark of Teva Canada Innovation