AVONEX Safety Profile – AVONEX® (interferon beta-1a) Side Effects

AVONEX Safety Profile

Experience and safety in relapsing MS

The safety of AVONEX® (interferon beta-1a) was studied in 2 well-controlled clinical trials, the same trials that proved AVONEX effective in treating relapsing multiple sclerosis (MS).

AVONEX was FDA approved as a result of these trials, and has developed a long heritage in treating relapsing MS in the nearly 2 decades since. However, because the longest clinical trial of AVONEX lasted for 3 years, the safety and effectiveness of treatment with AVONEX beyond 3 years is not known.

A well-understood safety profile

Here is some Important Safety Information you should know about once-a-week AVONEX.

Before taking AVONEX, you should tell your healthcare provider if you:

  • are being treated for a mental illness, or had treatment in the past for any mental illness, including depression and suicidal behavior
  • have or had bleeding problems or blood clots, have or had low blood cell counts, have or had liver problems, have or had seizures (epilepsy), have or had heart problems, have or had thyroid problems
  • have or had any kind of autoimmune disease (where the body's immune system attacks the body's own cells), such as psoriasis, systemic lupus erythematosus, or rheumatoid arthritis
  • drink alcohol
  • are pregnant or plan to become pregnant. It is not known if AVONEX will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with AVONEX
  • are breastfeeding or plan to breastfeed. It is not known if AVONEX passes into your breast milk. You and your healthcare provider should decide if you will use AVONEX or breastfeed. You should not do both

AVONEX can cause serious side effects, such as heart problems, including heart failure. While AVONEX is not known to have any direct effects on the heart, a few patients who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking AVONEX. If you already have heart failure, AVONEX may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using AVONEX.

Some people using AVONEX may have other heart problems including:

  • low blood pressure
  • fast or abnormal heart beat
  • chest pain
  • heart attack or a heart muscle problem (cardiomyopathy)

In addition, if you are allergic to AVONEX or any of the ingredients in AVONEX, do not take AVONEX. And if you experience an allergic reaction to AVONEX, stop taking AVONEX and talk to your healthcare provider about your treatment options.

After you review the benefits and risks of AVONEX with your healthcare provider, he or she may ask you to have regular blood tests to make sure your liver is functioning properly.

Most people who take AVONEX have flu-like symptoms early during the course of therapy. Usually, these symptoms last for a day after the injection. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Symptoms may include muscle aches, fever, tiredness, and chills.


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Important Safety Information and Indication

AVONEX can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking AVONEX.

Indication

AVONEX (interferon beta-1a) is approved by FDA to treat relapsing forms of multiple sclerosis (MS) to decrease the number of flare-ups and slow the occurrence of some of the physical disability that is common in people with MS. AVONEX is approved for use in people who have experienced a first attack and have lesions consistent with MS on their MRI.

Important Safety Information

Before beginning treatment, you should discuss with your healthcare provider the potential benefits and risks associated with AVONEX.

AVONEX can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking AVONEX.

AVONEX will not cure your MS but may decrease the number of flare-ups of the disease and slow the occurrence of some of the physical disability that is common in people with MS. MS is a life-long disease that affects your nervous system by destroying the protective covering (myelin) that surrounds your nerve fibers.

The way AVONEX works in MS is not known. It is not known if AVONEX is safe and effective in children.

Do not take AVONEX if you are allergic to interferon beta, albumin (human), or any of the ingredients in AVONEX.

Before taking AVONEX, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

AVONEX can cause serious side effects including:

Tell your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of AVONEX include:

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information and Medication Guide for additional important safety information. This information is not intended to replace discussions with your healthcare provider.

Indication

AVONEX (interferon beta-1a) is approved by FDA to treat relapsing forms of multiple sclerosis (MS) to decrease the number of flare-ups and slow the occurrence of some of the physical disability that is common in people with MS. AVONEX is approved for use in people who have experienced a first attack and have lesions consistent with MS on their MRI.