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Welcome to the website of the
Southwest Virginia MS Support Group
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Betaseron®
The information in this medication sheet has been
adapted from the FDA-approved prescribing information for
Betaseron.
Description
Betaseron is a medication manufactured by a
biotechnological process from one of the naturally occurring
interferons (a type of protein). In a clinical trial of 372
ambulatory patients with relapsing-remitting MS, those taking
the currently recommended dose of the medication experienced
fewer exacerbations, a longer time between exacerbations, and
exacerbations that were generally less severe than those of
patients taking a lower dose of the medication or a placebo.
Additionally, patients on interferon beta-1b had no increase
in total lesion area, as shown on MRI, in contrast to the
placebo group, that had a significant increase.
Approval by the U.S. Food and Drug Administration (FDA)
Betaseron is approved by the FDA for the treatment of
relapsing forms of MS to reduce the frequency of clinical
exacerbations. Relapsing forms of MS include individuals with
secondary-progressive MS who continue to experience relapses
or acute attacks. Betaseron is also approved for used in
individuals who have experienced a first clinical episode
(clinically-isolated syndrome) and have MRI features that are
consistent with multiple sclerosis.
Proper Usage
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Betaseron is injected subcutaneously (between the fat
layer just under the skin and the muscles beneath) every
other day. The physician or nurse will instruct you in the
injection procedure, 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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Betaseron is supplied with a pre-filled diluant syringe
to which the medication needs to be added prior to
injection; no refrigeration is necessary.
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Do not reuse needles or syringes. Dispose of the
syringes as directed by your physician and keep them out of
the reach of children.
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Since flu-like symptoms are a common side effect
associated with at least the initial weeks of taking
Betaseron, it is recommended that the medication be taken at
bedtime. Taking acetaminophen (Tylenol®) or ibuprofen
(Advil®) thirty minutes before each injection will also help
to relieve the flu-like symptoms.
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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. Injection site
necrosis [skin damage], which occurs in about 5% of patients
during the first four months of therapy, has been reported
in post-marketing studies even after a year of treatment. In
other to avoid infection and other complications, you should
report promptly any break in the skin, which may be
associated with blue-black discoloration, swelling, or
drainage of fluid from the injection site. Your physician
will determine whether to continue treatment while the skin
lesions are being treated.
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Warnings and Precautions
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In response to post-marketing findings (events that have
been reported by patients and doctors since Betaseron was
approved for use), the FDA has added warnings and
precautions to the prescribing information for this
medication:
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Depression and suicide
Betaseron should be used with caution in people who are
depressed, a condition which is very common in MS.
Depression, suicidal thoughts, and suicidal attempts have
been reported in people receiving various interferon
products, including Betaseron. Anyone who experiences
significand mood changes or suicidal thoughts should
report them promptly to his or her physician.
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Depression and suicide
Betaseron should be used with caution in people who are
depressed, a condition which is very common in MS.
Depression, suicidal thoughts, and suicidal attempts have
been reported in people receiving various interferon
products, including Betaseron. Anyone who experiences
significand mood changes or suicidal thoughts should
report them promptly to his or her physician.
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Liver problems
Betaseron, like other interferon medications, can affect
liver functions. In post-marketing studies, a few people
have developed severe liver injury. Periodic blood tests
to measure liver functions are recommended for any person
taking an interferon medication.
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Allergic reactions
Some people taking Betaseron have developed a severe
allergic reaction that interferes with breathing. An
allergic reaction can occur after the first dose, or not
until after several doses. Less severe reactions—including
itching, skin bumps, a rash, or swelling of the mouth and
tongue can also occur. Anyone who develops any kind of
allergic reaction should stop the medication immediately
and contact his or her physician.
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Seizures
Rebif should be used with caution in individuals with a
seizure disorder since seizures have been associated with
the use of beta interferon medications.
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Because of the potential of Betaseron to affect the
thyroid gland, and to alter the levels of white blood cells,
red blood cells, and platelets in a person’s system, blood
tests are recommended at regular intervals.
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Betaseron should not be used during pregnancy or by any
woman who is trying to become pregnant. Women taking
Betaseron should use birth control measures at all times.
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Possible Side Effects
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Common side effects include flu-like symptoms (fatigue,
chills, fever, muscle aches, and sweating) and injection
site reactions (swelling, redness, discoloration, and pain).
Most of these symptoms tend to disappear over time. If they
continue, become more severe, or cause significant
discomfort, be sure to talk them over with your physician.
Contact your physician if the injection sites become
inflamed, hardened, or lumpy, and do not inject into any
area that has become hardened or lumpy.
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Depression, including suicide attempts, has been
reported by patients taking Betaseron. Common symptoms of
depression are sadness, anxiety, loss of interest in daily
activities, irritability, low self-esteem, guilt, poor
concentration, indecisiveness, confusion, and eating and
sleep disturbances. If you experience any of these symptoms
for longer than a day or two, contact your physician
promptly.
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News about Betaseron
Jan 25, 2008
Researchers have found differences in genetic material
between people who respond to interferon beta treatment and
those who don’t, in a study of 287 people with
relapsing-remitting MS. These results, if confirmed by
larger studies and explored further, are an important step
toward using genetic information to predict who will respond
to specific therapies for MS, laying early groundwork that
may one day guide treatment decisions for patients and their
doctors.
Aug 03, 2007
In a study just published, researchers have shown for the
first time that early treatment can slow the rate at which
disability progresses in individuals who have had a first
event suggestive of multiple sclerosis but who have not yet
been diagnosed with definite MS. The study is a follow-up to
the completed, two-year BENEFIT study, in which treatment
with Betaseron® (interferon beta-1b, Bayer HealthCare
Pharmaceuticals) was shown to delay the onset of clinically
definite MS in people at high-risk for the disease compared
with people who did not receive treatment.
Oct 23, 2006
Berlex, Inc. (the U.S. affiliate of Schering AG) announced
today that the U.S. Food and Drug Administration (FDA) has
approved expanding the indication of Betaseron® (interferon
beta-1b, Berlex, Inc.) to include patients at high risk for
MS. These are individuals who have experienced a clinically
isolated syndrome (a single clinical event that is
indicative of demyelination, such as inflammation of the
optic nerve or an episode of numbness on one side) and have
MRI (magnetic resonance imaging) features consistent with
MS.
Aug 18, 2006
Results of the “BENEFIT” study which examined the ability of
Betaseron® (interferon beta-1b, Berlex Inc.) to delay the
onset of MS in people at high risk for developing the
disease have been published in the journal Neurology (Epub
August 16, 2006). People at high risk for MS are those who
experience a clinically isolated syndrome (CIS), a single
clinical event that is indicative of demyelination, such as
inflammation of the optic nerve or an episode of numbness on
one side.
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