Glatiramer Acetate Injection™ (glatiramer acetate) 20mg
DIN: 02541440
Mylan Pharmaceuticals ULC
Glatiramer acetate 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). Glatiramer Acetate Injection induces the production of immune cells that are less damaging to myelin.
Indications and use
Glatiramer Acetate Injection is indicated for treatment of ambulatory patients with Relapsing Remitting Multiple Sclerosis (RRMS), including patients who have experienced a single demyelinating event and have lesions typical of multiple sclerosis on brain MRI:
-To decrease the frequency of clinical exacerbations.
-To reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans.
Glatiramer Acetate Injection is contraindicated in people who are hypersensitive to this drug, to any ingredient in the formulation or component of the container.
Administration and dose
Glatiramer Acetate Injection 20mg is self-injected every day under the skin (subcutaneously). Glatiramer Acetate Injection is available in pre-filled syringes. The recommended dose of Glatiramer Acetate Injection is 20mg per day.
Mechanism of action
Glatiramer Acetate Injection is a mixture of peptides (or small proteins) that resemble a protein in myelin. Glatiramer Acetate Injection is thought to work by modifying the immune processes that are believed to cause MS.
Side effects*
The most common side effects of Glatiramer Acetate Injection 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 Glatiramer Acetate Injection.
Please see the Glatiramer Acetate Injection 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 Glatiramer Acetate Injection.)
Clinical Trials in Relapsing-Remitting MS
The efficacy of glatiramer acetate was evaluated in three placebo-controlled trials in participants with relapsing remitting MS (RRMS). The first trial (BR-1) was a single-center, double-blind, randomized, matched-pair, parallel-group placebo-controlled trial. The second study (01-9001) was a multicenter double-blind, randomized, placebo-controlled trial. Both studies showed a beneficial effect of glatiramer acetate on relapse rate. In a third placebo-controlled study (9003) the effects of glatiramer acetate on MRI parameters were assessed. The study found that glatiramer acetate significantly reduced the annualized relapse rate and decreased the number of new or enlarging T2 lesions and gadolinium-enhancing lesions on MRI scans. Additional information related to these studies can be found in the product monograph for Glatiramer Acetate Injection.
Clinical Trial in Early MS
The GA/9010 study was a multicenter, randomized, double-blind, placebo-controlled, parallel group study. Results of the study found that time to development of a second exacerbation was significantly delayed in the glatiramer acetate group compared with the placebo group.
Cost reimbursement
Reimbursement and availability of Glatiramer Acetate Injection will vary based on province. Speak to your prescribing neurologist, MS nurse, or pharmacist for more information.
Drug Support Program
Viatris AdvocateTM Patient Support Program
Phone: 1-888-223-0038
Fax: 1-844-751-9982
viatris.advocate@sdmshn.ca
Glatiramer Acetate Injection is a trademark of Mylan Pharmaceuticals ULC