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Avonex (Interferon Beta-1a) Provides Long-Term Efficacy in Relapsing Multiple Sclerosis

Multiple Sclerosis Drug Avonex (Interferon Beta-1a) As Effective As Betaseron (Interferon Beta-1b) With Fewer Side Effects

Avonex (Interferon Beta-1a) Slows Disability Progression In Secondary Progressive Multiple Sclerosis

Researchers Report on First Drug Shown to Slow Cognitive Impairment in MS Patients

Prefilled Syringe

Side effects

When you should not use this medicine


Treats multiple sclerosis.       
Brand Name(s): Avonex™
You should not use this medicine if you have had an allergic reaction to interferon beta or human albumin.


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, buttocks).
  • 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.
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 away.
  • 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:
  • Seizures
  • Unusual bleeding or bruising
  • Depressed mood, thoughts of hurting yourself
If you have problems with these less serious side effects, talk with your doctor
  • Flu-like symptoms (fever, chills, muscle aches)
  • Nausea
  • Diarrhea
  • Headache
  • 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 sclerosis.

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 treatment.

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 Effects


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 group.

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 percent).

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
North America.


Drug slows 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

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 Medicine.

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 wheelchair-dependent.

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 nerves.

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 disabilities.

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 placebo.

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 Patients

Portland, Oregon (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 cognitive functions,"

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 cognition.

"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."

Prefilled Syringe Information: How is it different?


  • AVONEX is the only MS therapy proven to be effective in people who have experienced a first attack and have MRI features consistent with MS.  In a 3-year study, AVONEX reduced the risk of a second attack by 44%.
  • Prefilled syringes of AVONEX provide concentrated once-a-week dosing, delivering the same amount of clinically proven medication in less volume of liquid. Prefilled syringes of AVONEX contain 30 mcg of Interferon beta-1a in 0.5 mL of liquid volume. The reconstituted powdered form of AVONEX contains 30 mcg of Interferon beta-1a in 1.0 mL of liquid volume.




  • Prefilled syringes of AVONEX are already mixed, thus making your injection process more convenient.
  • Prefilled syringes of AVONEX are administered intramuscularly, therefore the needle is still the same size.  If your doctor has recommended a smaller needle for injecting AVONEX, you will still be able to use it with the prefilled syringe.
  • Less diluent or "mixing solution" is required for the prefilled syringe, so the syringe is slightly smaller.  It is important to note that even though the amount of liquid within the syringe is less than before, 0.5 mL instead of 1.0 mL, you will still be receiving the same amount of AVONEX, 30 mcg of Interferon beta-1a.



  • Prefilled syringes of AVONEX have the same low incidence of neutralizing antibodies, 5%, as the powdered form (21 of 390 people using AVONEX and treated for at least 1 year).



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