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Welcome to the website of the
Southwest Virginia MS Support Group
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Copaxone® (glatiramer
acetate)
The information in this medication sheet has been
adapted from the FDA-approved prescribing information for
Copaxone.
Description
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. Through a mechanism
that is not completely understood, this drug seems to block
myelin-damaging T-cells by acting as a myelin decoy. In
controlled clinical trials with relapsing-remitting MS, those
taking the drug had a significant reduction in annual relapse
rate compared to control subjects who were given a placebo
Approval by the U.S. Food and Drug Administration (FDA)
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.
Proper Usage
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Glatiramer acetate is injected subcutaneously (between
the fat layer just under the skin and the muscles beneath)
once a day. The physician or nurse will instruct you in
correct injection procedures, using a specially designed set
of training materials. Do not attempt to inject yourself
until you are sure that you understand the procedures.
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The pre-filled syringes of glatiramer acetate should be
kept refrigerated. If refrigeration is not available, the
drug may be safely stored at room temperature for up to one
month.
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Glatiramer acetate is light-sensitive; protect it from
light when not injecting.
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Use each pre-filled syringe for only one injection.
Dispose of the syringes as directed by your physician and
keep them out of the reach of children.
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Because injection-site reactions (swelling, redness,
discoloration, or pain) are relatively common, it is
recommended that the sites be rotated according to a
schedule provided for you by your physician. Do not use any
one site more than once per week.
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Warnings and Precautions
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Do not use a pre-filled syringe that appears cloudy or
contains particles.
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Do not change the dose or dosing schedule of this
medication without consulting your physician.
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Glatiramer acetate is not recommended for use during
pregnancy. Women who wish to become pregnant should discuss
this medication, and all others they are taking, with their
physician. If you become pregnant while on the medication,
inform your physician. Glatiramer acetate is a Pregnancy
Category B medication, meaning that although no adverse
effects have been found in animal studies, no adequate,
well-controlled studies have been done in pregnant women to
demonstrate its safety in humans.
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It is not known whether glatiramer acetate passes into
the breast milk. Nursing women should discuss the use of
this medication with their physician.
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Possible Side Effects
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Side effects that generally resolve on their own and do
not require medical attention unless they continue for
several weeks or are bothersome: injection-site reactions
(e.g., swelling, the development of a hardened lump,
redness, tenderness, increased warmth of the skin, itching
at the site of the injection); runny nose; tremor*; unusual
tiredness or weakness*; weight gain.
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Unusual side effects that should be discussed as soon as
possible with your doctor:
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Hives (an itchy, blotchy swelling of the skin) or severe
pain at the injection site.
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Possible immediate post-injection reaction:
Approximately 13% of individuals using Copaxone will
experience, at one time or another, a transient (very
temporary) reaction immediately after injecting glatiramer
acetate. This reaction, which usually occurs only once,
includes flushing or chest tightness with heart
palpitations, anxiety, and difficulty breathing. During the
clinical trials, these reactions occurred very rarely,
usually within minutes of an injection. They lasted
approximately 15 minutes and resolved without further
problem.
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Since it may be difficult to distinguish between certain
common symptoms of MS and some side effects of glatiramer
acetate, be sure to consult your health care professional if
an abrupt change of this type occurs.
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News about Copaxone
Dec 06, 2007
Copaxone® (glatiramer acetate, Teva Pharmaceutical
Industries) significantly reduced the risk of developing MS
and delayed the development of MS in individuals with CIS
(clinically isolated syndrome, a first event suggestive of
MS) enrolled in the PreCISe study, according to a company
press release dated December 3, 2007. Based on these
results, the company is stopping the study early and is
giving all participants, including those who were taking
inactive placebo, an opportunity to receive Copaxone for two
years. The company also reports that it plans to file
requests with regulatory authorities in the U.S., Europe and
Canada to expand the labeling of Copaxone to include
patients with CIS.
Jul 25, 2006
Researchers report that giving Copaxone® (glatiramer
acetate) after a short course of Novantrone® (mitoxantrone)
appeared to be safe and effective in an open-label,
uncontrolled study involving 27 people with very active
relapsing-remitting MS. Drs. Mike Boggild, Jason Ramtahal
and colleagues (The Walton Centre for Neurology and
Neurosurgery, Liverpool, UK) report their results in an
upcoming issue of The Journal of Neurology.
Jul 20, 2006 Researchers have found a new explanation for the effects of
Copaxone® (glatiramer acetate, Teva Pharmaceuticals), a
treatment approved for relapsing-remitting multiple
sclerosis. Nitin J. Karandikar, MD, PhD (University of Texas
Southwestern Medical Center, Dallas), a Harry Weaver
Neuroscience Scholar of the National MS Society, and
colleagues report their findings in the Journal of
Immunology (2006 Jun 1;176(11):7119-29).
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