WHEN YOU SHOULD NOT USE THIS MEDICINE
|You should not use this medicine if you have had an allergic
reaction to interferon beta or human albumin.
|HOW TO USE AND STORE THIS
|This medicine is very strong. Make sure you understand why you are
getting it and what the risks and benefits of treatment are. It is
important for you to work closely with your doctor.
Intramuscular (IM) Injection:
- Your doctor will prescribe your dose and tell you how often it
should be given.
- An IM injection is a shot given in your muscle (upper arm, thigh,
- A nurse or other caregiver trained to give shots will give your
treatment. Sometimes you, a family member, or a friend can be taught
to give your medicine.
- The medicine comes as a powder that needs to be mixed with sterile
water before it is given. If you give your own shots, you should
receive an instruction sheet that tells you how to mix the medicine
with the sterile water. You should also get information on how to use
the syringe and give the shot. Make sure you read the sheets carefully
and understand the information before you have your shot.
- If you have your shots at home, you may need to store your
medicine and the sterile water. Keep them in the refrigerator. Do not
freeze. If you can't keep the medicine in the refrigerator, it can be
kept in a cool dry place for up to 30 days (before it is mixed in the
syringe). Keep the medicine away from heat or sunlight.
- Before your shot, take the medicine and sterile water out of the
refrigerator and let them warm to room temperature.
- After the medicine has been mixed with sterile water, it should be
used as soon as possible. If you can't give your shot right away, you
can keep the syringe in the refrigerator for up to 6 hours. After 6
hours, mix a new dose of the medicine.
- Before your shot, check the medicine in the syringe. The liquid
should be clear and light yellow. You should not use the medicine if
it has changed color or has lumps or solid pieces in it. Get a new
syringe and mix another dose.
- Keep all medicine out of the reach of children.
- If you have your treatments at home, you should be given a special
container for the used needles and tubes. Put it where children or
pets cannot reach it.
- You should not use needles and syringes more than once or share
them with anyone else.
|If you miss a dose:
- If you get the medicine once a week, take the missed dose as soon
as possible. Then, go back to your regular schedule, unless it is less
than 2 days until your next regular shot. If it is less than 2 days
until your next shot, call your doctor for instructions.
|DRUGS AND FOODS TO AVOID
|Ask your doctor or pharmacist before using any other medicine,
including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also taking zidovudine
(AZT, or Retrovir®).
- Before taking this medicine, make sure your doctor knows if you
have heart, liver, or lung disease, asthma, or seizures (epilepsy) or
if you have ever been treated for depression.
- You may have a mild fever, chills, and muscle aches when you first
start using this medicine. Talk with doctor about what medicines you
can take to help prevent these problems.
- If you start to have a depressed mood or thoughts of hurting
yourself, tell your doctor right away.
- Your doctor may want to check your blood on a regular schedule
while you are receiving this medicine. Keep all of the appointments
your doctor makes for you.
- Do not get pregnant while you are getting interferon. Use a
reliable method of birth control while you are being treated. If you
become pregnant, stop using the medicine and tell your doctor right
- If you are already pregnant, talk to your doctor before you start
your treatments. This medicine may be harmful to your unborn baby.
|Call your doctor right away if you have any of these side effects:
- Unusual bleeding or bruising
- Depressed mood, thoughts of hurting yourself
|If you have problems with these less serious side effects, talk with
- Flu-like symptoms (fever, chills, muscle aches)
- Pain or discomfort where the shot is given
Avonex (Interferon Beta-1a) Provides Long-Term
Efficacy in Relapsing Multiple Sclerosis
By Jill Stein
Special to DG News
DENVER, CO -- April 19, 2002 -- New findings
indicate that once weekly intramuscular Avonex (interferon beta-1a) at doses
of 30 µg or 60 µg are equally in effective in treating relapsing multiple
The results, presented at the 54th
Annual Meeting of the American Academy of Neurology, (AAN) also indicate
that the efficacy of the two doses is sustained after four years of
The trial's principal investigator was Dr.
Ludwig Kappos, with University Hospitals in Basel, Switzerland.
For the study, patients with relapsing
multiple sclerosis (MS) who had completed at least three years of treatment
as part of the European Interferon Beta-1a Dose-Comparison Study were given
the option to continue double-blind treatment with either 30 µg or 60 µg
intramuscularly once weekly until the completion of the trial. Of 608
patients who completed the first part of the study, 491 subjects had
four-year follow-up and 446 completed four years of treatment and follow-up.
The 30 µg and 60 µg treatment groups were
similar with respect to age, gender, race, duration of MS, Expanded
Disability Status Scale score, magnetic resonance imaging measures of
disease activity, and pre-study exacerbation rates.
Analysis of four-year data was conducted on
several end points: cumulative rate of sustained disability progression,
extent of change in Expanded Disability Status Scale score, relapse rate,
and percentage of relapse-free patients, use of intravenous steroids, and
neutralizing antibody (NAB) formation.
Results showed that the two study doses were
equally effective for up to four years, and there were no significant
differences between doses on any of the clinical end points.
Overall, 52 percent of patients in the 30 µg
group were free of disability progression at four-year follow-up compared
with 57 percent in the 60 µg group (rate ratio, 0.89; 95 percent confidence
interval [CI], 0.72 to 1.11; p = 0.32). The percentage of relapse-free
patients was 18 and 19 percent in the two groups, respectively (p=0.85).
The incidence of patients who were NAB
formation at any time during the study was 2.3 percent in the 30 µg group
and 5.8 percent in the 60 µg group (p=0.011).
Dr. Kappos said that the investigation is
the largest long-term study ever conducted in MS without patient
re-randomization. He also noted that the results concur with the effects of
interferon beta-1a on sustained disability progression observed in the
pivotal phase III trial.
The trial was supported by Biogen, Inc.
Multiple Sclerosis Drug Avonex (Interferon
Beta-1a) As Effective As Betaseron (Interferon Beta-1b) With Fewer Side
BARI, ITALY -- December 10, 2001 -- The use
of interferon beta-1a (Avonex®) for the treatment of relapsing-remitting
multiple sclerosis (RRMS) stabilizes the disease by delaying progression of
patient disability, according to an independent study presented at the 17th
Congress of the European Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS 2001) in September.
The study found that Avonex, when compared to
interferon beta-1b (Betaseron® in United States; Betaferon outside the
U.S.), might also favorably impact the quality of life of patients with
multiple sclerosis (MS).
The study found that both Avonex and Betaseron
demonstrated efficacy in reducing relapses associated with RRMS. Avonex
dosed once weekly reduced relapses by 65 percent, compared to 59 percent in
the Betaseron group dosed every 48 hours.
"This study confirms that treatment with both
interferon beta therapies is well tolerated and effective for patients with
relapsing-remitting MS," said Professor Maria Trojano, Neurologist in charge
of the MS Center, at the Department of Neurological and Psychiatric
Sciences, directed by Professor Paolo Livrea, University of Bari, Bari,
Italy, and lead investigator of the study. "However, patients treated with
interferon beta-1a may have a better compliance rate than patients treated
with interferon beta-1b due to the infrequency of adverse events."
Patients treated with Avonex experienced a
lower incidence of side effects during treatment initiation. In the first
three months of treatment, patients treated with Betaseron experienced more
clinical and hematologic side effects compared with Avonex patients.
Even though the incidence of side effects
declined during the first year of treatment, patients treated with Betaseron
continued to experience more injection-site reactions. Fewer Avonex patients
discontinued treatment during the trial than did patients treated with
Betaseron (9 percent versus 19 percent).
The population-based surveillance study was
conducted to evaluate the efficacy and safety of Avonex and Betaseron in
RRMS patients. Relapse rates, Expanded Disability Status Scale (EDSS)
scores, adverse events, and study dropouts were evaluated every three months
during the two-year study. Of the patients enrolled, 408 patients completed
two years of treatment with either Avonex (177 patients) or Betaseron (231
patients). Patients in both treatment groups had significant reduction in
relapse rates at all time points compared with baseline. While no
differences were shown in mean relapse rates or mean EDSS scores from
baseline to year two, patients in the Avonex treated group experienced no
significant change in EDSS scores, which measure physical disability,
compared to a significant increase over baseline in the Betaseron- treated
The study, led by researchers at the University
of Bari in Bari, Italy and conducted through a network of 16 specialized MS
Centers throughout southern Italy, enrolled 1,033 patients with RRMS.
Results also showed that age at treatment onset and the pre-treatment
disease duration and relapse rate are all factors influencing the clinical
response to treatment. These findings suggest that the earlier patients
start on treatment, the better they will respond to therapy.
The most common side effects experienced by
enrollees treated with Avonex compared to Betaseron included fever (50
percent vs. 70 percent), depression (6 percent vs. 14 percent), leukopenia
(increased risk of infection) (6 percent vs. 22 percent), anemia (reduction
in the concentration of red blood cells) (5 percent vs. 18 percent), and
thrombocytopenia (reduction in the number of platelets) (1 percent vs. 4
Multiple sclerosis (MS) is a chronic disease of
the central nervous system that affects approximately 400,000 Americans and
about one million individuals worldwide. It is a disease of young adults,
mostly women, with onset typically between 20 and 40 years of age. Symptoms
of MS may include vision problems, loss of balance, numbness, difficulty
walking and paralysis.
The disease is believed to be caused by the
destruction of myelin by the immune system. Myelin is the fatty tissue that
surrounds and protects central nervous system nerve fibers and facilitates
the flow of nerve impulses to and from the brain. The loss of myelin
disrupts the conduction of nerve impulses, producing the symptoms of MS.
SOURCE University of Bari
Avonex (Interferon Beta-1a) Slows Disability Progression In Secondary
Progressive Multiple Sclerosis
By Jill Stein
Special to DG News
PHILADELPHIA, PA -- May 9, 2001-- New findings indicate that Avonex
(interferon beta-1a) is an effective treatment for secondary
progressive multiple sclerosis (MS).
The Food and Drug Administration (FDA) approved Avonex for the
treatment of relapsing remitting MS.
The data, from a phase III study reported at the 53rd Annual Meeting
of the American Academy of Neurology (AAN), showed that patients with
secondary progressive MS who were treated with Avonex had a 40
percent decrease in the progression of disability compared to
patients who received a placebo.
"Our results are important because they demonstrate that Avonex also
benefits patients at later stages of the disease," said Dr. Jeffrey
A. Cohen, with the Cleveland Clinic Foundation in Cleveland Clinic.
Currently, none of the FDA approved drugs for the treatment of
relapsing remitting MS has been approved for the treatment of the
secondary progressive form of the disease. The present study tested
the efficacy of Avonex for the treatment of the more progressive form
of the disease.
The trial included 426 patients with clinically definite MS, a
secondary progressive course with or without recent relapses, and a
baseline Expanded Disability Status Scale (EDSS) score of 3.5-6.5
Subjects were randomized to treatment with Avonex 60 µg or placebo by
weekly intramuscular injection.
The primary disease end point was disease progression as measured by
the MS Functional Composite Score (MSFC), a measurement of
ambulation, arm movement and cognitive function.
In addition to a decrease in the median disability progression
favoring Avonex, Avonex-treated patients had a 33 percent decrease in
the disease relapse rate.
No benefit was seen on clinical measures driven by ambulation.
Avonex-treated patients also had improvement in eight of 11 Quality
of Life Inventory subscales and experienced a reduction in new or
enlarging T2 hyper-intense cranial magnetic resonance imaging (MRI)
lesions and gadolinium enhancements at months 12 and 24.
The International Multiple Sclerosis Secondary Progressive Avonex
Clinical Trial (IMPACT) was conducted at 42 centers in Europe and
onset of MS, study finds
Patients who had early signs
of the disease were given Avonex. It costs $10,000 a year, though.
By Shankar Vedantam
INQUIRER STAFF WRITER
Aggressively treating patients with very early signs
of multiple sclerosis - well before the crippling nerve disease is usually
diagnosed - can delay the onslaught of the disease and mute its damage.
A study, conducted in 50 centers across the United States and Canada,
including in Philadelphia, found results so dramatic that researchers
stopped the trial midway and called for early drug intervention for all
patients at risk for MS.
"This is huge," said Steven Galetta, a professor of neurology at the
University of Pennsylvania, one of the centers that studied the impact of
early treatment with the drug Interferon beta-1A. "It has profound
implications regarding those patients at high risk for MS."
"The earlier you treat MS, the better off you are," he said.
The study is to be published tomorrow in the New England Journal of
The study was sponsored by Cambridge, Mass.-based Biogen Inc., a
biotechnology firm that sells the drug Avonex, used in the trial. Avonex is
commonly used for MS patients but has not been prescribed so early.
Multiple sclerosis affects about 350,000 people in the United States,
according to the National Multiple Sclerosis Society. Women are two to three
times more likely to be affected than men.
The disease is characterized by symptoms such as blurred or weakened vision,
weakness in the fingers and toes, numbness and imbalance. It sometimes
progresses to the point where patients are partially paralyzed and
Scientists have found that symptoms are caused by the destruction of the
myelin sheath that covers nerve fibers – akin to the breakdown of the
insulation of a telephone wire. This disrupts the transmission of messages
within the nervous system and increases the risk of damage to the underlying
Piecing together a diagnosis of MS from early symptoms can be difficult
since they are common to other conditions and sometimes go away. Doctors
have so far relied on multiple outbursts - or relapses - and MRI brain scans
to make a diagnosis and begin treatment.
The new study and other research indicates that waiting to treat MS may be
harmful. Long before physical symptoms develop, the brains of MS patients
appear to undergo a steady, stealthy assault.
And for each flare-up in physical symptoms, said doctors, there may be a
dozen silent attacks in the brain. These attacks can cause lapses in
concentration, memory, attention and judgment as well as physical
The study recruited 383 patients who had reported a single outburst of
symptoms. An MRI scan established that they were at risk for MS. One half
received weekly injections of interferon beta-1A, a drug currently used to
treat fully diagnosed MS, while the rest received a dummy injection or
After three years of follow-up, scientists found that 44 percent fewer
patients in the drug group had developed a second outburst of symptoms
compared with those in the placebo group. Since the second outburst is the
traditional point at which a diagnosis of MS is made, the scientists
concluded that their treatment had substantially delayed the disease.
Even more impressive, according to the researchers, treated patients saw 90
percent fewer brain lesions in certain MRI scans, a crucial benefit, given
that such damage to the brain is irreversible.
Eventually half the patients in the placebo group went on to develop MS,
compared with just over a third in the group that got the drug.
Lawrence Jacobs, professor of neurology at the State University of New York
in Buffalo and the lead investigator of the study, said the results boded
well for long-term prognosis.
"It's very good to increase the length of time between the first and second
relapse and reduce the number of lesions," he said.
Two difficulties can prevent the implementation of the study results: A
year's supply of Avonex can cost $10,000, raising questions about access to
care. Second, with the inherent difficulty in diagnosis, patients need to
take early symptoms seriously and consult a neurologist, Jacobs said.
The most common early signs to watch for, he said, are lost vision in one
eye, pain with eye movements, double vision, coordination problems, and an
electric shock-like sensation down the spine when the chin is pressed
against the chest.
Researchers Report on First Drug Shown to Slow Cognitive Impairment in MS
(December 4, 2000)
Treatment with Avonex® (Interferon beta-1a) has Proven
Positive Effect on Cognition
A new study published in the Annals of Neurology shows
that treatment with interferon beta-1a, or Avonex, has a significant
beneficial effect on the cognitive impairment often suffered by people with
relapsing multiple sclerosis (MS). Researchers report that
patients treated with Avonex, an MS therapy already proven
to reduce MS relapses and to slow the progression of the disease, performed
significantly better than placebo-treated patients on measures of cognitive
functioning most commonly disrupted by MS. In fact, patients treated with
Avonex had a 47 percent reduction in the risk of experiencing
cognitive deterioration versus patients who were treated with placebo.
According to Oregon Health Sciences University, about half
of all people with multiple sclerosis experience some form of cognitive
dysfunction, such as memory loss, slowed information processing and
difficulty in problem solving. Cognitive dysfunction, not physical
disability, is cited as the most common reason people with MS leave the work
force. More than 400,000 people in the U.S. and over one million worldwide
have multiple sclerosis. "The loss of cognitive abilities is a common, yet
under-recognized, problem of MS, a disease best known for its debilitating
effect on one's physical abilities, not mental abilities," said study
co-author Dennis N. Bourdette, M.D., Director, Multiple Sclerosis Center of
Oregon, Oregon Health Sciences University. "This study shows that proactive
treatment with Avonex has a significant overall positive effect on cognitive
functioning in patients with relapsing multiple sclerosis."
Researchers led by Jill Fischer, Ph.D., a
neuropsychologist at the Cleveland Clinic's Mellen Center for MS Treatment
and Research at the time the research was conducted, administered a
comprehensive battery of neuropsychological tests to a subset of 166 persons
with MS enrolled in the original double-blind,
placebo-controlled trial of Avonex in relapsing MS.
"According to the study, patients treated with Avonex were
almost 50% less likely to worsen neuropsychologically compared to those who
did not receive Avonex therapy," Bourdette said. "It is clear that cognitive
dysfunction should be considered when making decisions regarding
disease-modifying therapy in MS."
The positive effects of Avonex were most pronounced on
cognitive domains most frequently affected by MS. These areas include
information processing (the ability to focus, sustain and shift attention
particularly when information is presented rapidly) and learning and memory
tasks (ability to learn new information and remember it later). There was
also a beneficial trend in other cognitive domains that are impaired
moderately often in MS, including higher-level executive functions and
visuospatial abilities. "This is the first multi-center clinical trial in MS
to prospectively assess neuropsychological outcomes across a wide range of
said Fischer. "We believe that treatment with Avonex
exerts its neuropsychological effects via both short- term mechanisms, by
inhibiting inflammation, and longer term mechanisms by slowing or preventing
further central nervous system tissues damage. By modifying the disease
process in MS, we may be able to preserve important cognitive functions that
can directly affect a person's ability to carry out those daily activities
that are most important to him or her."
According to Dr. Bourdette, this extensive and
irreversible cognitive impairment is most likely attributable to cerebral
plaque accumulation and brain atrophy. Avonex has already been clinically
proven to favorably affect brain atrophy and cerebral lesions. Previous
studies with other MS treatments failed to show the same positive effect on
"MS-related cognitive dysfunction can have a devastating
impact on individuals with MS and their families, affecting employment,
social functioning and quality of life," said Stephen Reingold, Ph.D., Vice
President Research, of the National Multiple Sclerosis Society. "This new
report is important because it indicates that treatment with this
disease-modifying agent, Avonex, can have significant impact on this
important symptomatic problem that affects many with MS."