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The information in this medication sheet has been adapted from the FDA-approved prescribing information for Avonex.

Description

Avonex is a medication manufactured by a biotechnological process from one of the naturally-occurring interferons (a type of protein). It is made up of exactly the same amino acids (major components of proteins) as the interferon beta found in the human body. In controlled clinical trials in relapsing MS, those taking the medication had a reduced risk of disability progression, experienced fewer exacerbations, and showed a reduction in number and size of active lesions in the brain (as shown on MRI) when compared with the group taking a placebo. In a subsequent study of patients who had experienced a single demyelinating event in the optic nerve, spinal cord, or brainstem, and had lesions typical of MS on brain MRI, Avonex significantly delayed the time to a second exacerbation, and thus to a clinically definite diagnosis of MS.

Approval by the U.S. Food and Drug Administration (FDA)

Avonex is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with MS in whom efficacy has been demonstrated include those who have experienced a first clinical episode and have MRI features consistent with MS.

Proper Usage

• Avonex is given as a once-a-week intramuscular (IM) injection, usually in the large muscles of the thigh, upper arm, or hip.
• You and your care partner will be instructed in safe and proper IM injection procedures. If you are unable to self-inject, and have no family member or friend available to do the injections, your physician or nurse will administer the injections. Do not attempt inject yourself until you are sure that you understand the procedures.
• Avonex comes in two different forms—as a liquid in a pre-filled syringe and as a powder in a single-use vial.
  • Pre-filled syringe: Store all unused syringes in the refrigerator. Let each syringe come to room temperature (about 20 minutes) prior to injecting. Do not expose the medication to high temperatures (in a glove compartment or on a window sill, for example) and do not allow it to freeze. Do not reuse the pre-filled syringes. Dispose of the syringes as directed by your physician and keep them out of the reach of children.
  • Powder: Vials should be stored in the refrigerator, but can be kept for up to 30 days at room temperature. Avoid exposing the vials to high temperatures or to freezing temperatures. After mixing, the Avonex solution should be used immediately or within six hours when stored in the refrigerator.
• Since flu-like symptoms are a fairly common side effect during the initial weeks of treatment, it is recommended that the injection be given at bedtime. Taking acetaminophen (Tylenol®) or ibuprofen (Advil®) immediately prior to each injection and during the 24 hours following the injection will also help to relieve the flu-like symptoms.

Warnings and Precautions

• In response to post-marketing findings (events that have been reported by patients and doctors since Avonex was approved for use), the FDA has added warnings and precautions to the prescribing information for this medication:
  • Depression and suicide
    It is recommended that individuals with a history of severe depressive disorder or other mental disorder be closely monitored while taking Avonex. The people receiving Avonex in the original clinical trial did not report an increase in depression. However, depression and suicidal thoughts are known to occur with some frequency in MS, and depression and suicidal thoughts have been reported with high doses of various interferon products. In addition, there have been post-marketing reports of depression, suicidal thoughts and/or development of new or worsening of other pre-existing psychiatric disorders, including psychosis. Some of these patients improved when they stopped the medication.
  • Seizures
    Avonex should be used with caution in individuals with a seizure disorder. A few individuals with no prior history of seizures have experienced seizures while on Avonex. Since seizures are known to occur somewhat more frequently in people with MS than in the general population, it is not known whether these seizures were related to the MS, to the medication, or to some combination of the two.
  • Heart problems
    People with cardiac disease should be closely monitored for a worsening of their condition. While Avonex is not known to cause cardiac problems, there have been infrequent post-marketing reports of congestive heart failure and other cardiac problems in people with no prior history and no other factors predisposing them to heart problems.
  • Liver problems
    Avonex, 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.
  • Allergic reactions
    Some people taking Avonex 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.
  • Blood problems
    Avonex can cause a reduction in levels of infection-fighting blood cells, red blood cells, or cells that help to form blood clots. Severe changes of this kind can lessen a person’s ability to fight infections and cause tiredness. Periodic blood tests can identify changes in levels of these important types of cells.
• Prior to taking Avonex, be sure to tell your physician if you have ever had any of the following medical problems:
  • Depression, anxiety, or trouble sleeping
  • Problems with your thyroid gland
  • Blood problems such as bleeding or bruising easily, anemia, low white cell count
  • Seizures
  • Heart problems
  • Liver disease
• Avonex should not be used during pregnancy or by any woman who is trying to become pregnant. Women taking Avonex should use birth control measures at all times. If you want to become pregnant while being treated with Avonex, discuss the matter with your physician. If you become pregnant while using Avonex, stop the treatment and contact your physician.

Possible Side Effects

• Common side effects include flu-like symptoms (fatigue, chills, fever, muscle aches, and sweating). Most of these symptoms will tend to disappear after the initial few weeks of treatment. If they continue, become more severe, or cause you significant discomfort, be sure to talk them over with your physician.
• Symptoms of depression, including ongoing sadness, anxiety, loss of interest in daily activities, irritability, low self-esteem, guilt, poor concentration, indecisiveness, confusion, and eating and sleep disturbances, should be reported promptly to your doctor.