Overview:
Glatopa™ (glatiramer acetate) is a synthetic protein that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This drug seems to block myelin-damaging T-cells through a mechanism that is not completely understood.
Glatiramer acetate is approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency of relapses in patients with relapsing-remitting MS. It is also approved for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with multiple sclerosis.
The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS is (are) not fully elucidated. However, it is thought to act by modifying immune processes that are currently believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental allergic encephalomyelitis (EAE), a condition induced in several animal species through immunisation against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in MS patients suggest that upon its administration, glatiramer acetate-specific suppressor T cells are induced and activated in the periphery.
Glatopa™ is the generic equivalent of Copaxone (glatiramer acetate) 20mg. The U.S. Food and Drug Administration (FDA) has approved Glatopa as substitutable for Copaxone 20mg; it is not substitutable for Copaxone 40mg.
Dosing:
Glatopa™ comes in a prefilled syringe and is given by subcutaneous (under the skin) injection once a day. The recommended daily dose of Glatopa™ is 20 mg. To keep track of your schedule for taking glatiramer acetate, you should plan your injection at the same time every day.
Glatopa™ pre-filled syringes should be refrigerated.
Efficacy:
A total of 269 patients have been treated with glatiramer acetate in three controlled trials. The first was a two-year study involving 50 patients (glatiramer acetate n=25, placebo n=25) who were diagnosed with relapsing-remitting MS by the then-applicable standard criteria, and who had at least two attacks of neurological dysfunction (exacerbations) during the preceding two years. The second study applied the same inclusion criteria and included 251 patients treated for up to 35 months (glatiramer acetate n=125, placebo n=126). The third study was a nine-month study involving 239 patients (glatiramer acetate n=119, placebo n=120) where inclusion criteria were similar to those in the first and second studies with the additional criterion that patients had to have at least one gadolinium-enhancing lesion on the screening MRI.
In clinical trials in MS patients receiving glatiramer acetate, a significant reduction in the number of relapses, compared with placebo, was seen.
In the largest controlled study, the relapse rate was reduced by 32% from 1.98 under placebo to 1.34 under glatiramer acetate.
Exposure data are available for up to twelve years in 103 patients treated with glatiramer acetate.
Glatiramer acetate has also demonstrated beneficial effects over placebo on MRI parameters relevant to relapsing-remitting MS.
Glatiramer acetate had, however, no beneficial effect on progression of disability in relapsing-remitting MS patients.
There is no evidence that glatiramer acetate treatment has an effect on relapse duration or severity.
There is currently no evidence for the use of glatiramer acetate in patients with primary or secondary progressive disease.
Side Effects:
Some patients report a short-term reaction right after injecting glatiramer acetate. 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 do not require specific treatment. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, call the emergency phone number in your area. Call your doctor right away if you develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, do not give yourself any more injections until your doctor tells you to begin again.
Chest pain may occur either as part of the immediate postinjection reaction or on its own. This pain should only last a few minutes. You may experience more than one such episode, usually beginning at least one month after starting treatment. Tell your doctor if you experience chest pain that lasts for a long time or feels very intense.
A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Be sure to follow proper injection technique and inform your doctor of any skin changes.
The most common side effects in studies of glatiramer acetate 20mg/mL are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of glatiramer acetate. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects you have while taking Glatopa.
Sandoz history dates back more than 120 years, during which time it has transformed itself from a small diversified chemical company to the world’s second largest producer of high-quality generic pharmaceuticals and global leader in biosimilars and differentiated products. Throughout our long and distinguished history, we have been led by dedicated and visionary individuals who have always aspired to be one step ahead and who have delivered success through high-quality products and services.
Website: http://glatopa.com/
