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Snapshot of Avonex® (Interferon beta-1a)


Avonex®: Descriptives1
Method of administration Intramuscular (into the muscle) injection
Indication For the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations
Needle size 1 ¼" length
1" needle available by prescription only
Delivery Information Lyophilized powder vials or prefilled syringes. Lyophilized powder vials require reconstitution (mixing) and filling syringes before injection.
Injection aids(s) None
Pregnancy category Category C1 (when administered to pregnant animals, there was some harm to the fetus)2
Black box warning No

Avonex®: Common side effects/reactions1
Clinically significant difference in flu-like symptoms when compared to placebo (an inactive substance) Yes
Fatigue/Malaise (bodily discomfort) increased while on therapy Yes
Warning for use in people with depression Yes
Warning for use in people with suicidal thoughts Yes
Warning or precaution for liver impairment Yes
Recommended monitoring of liver function or complete blood count Yes
Associated with localized site reactions No
Associated with neutralizing antibodies (proteins produced by the body that may decrease the effectiveness of therapy) Yes

Additional important information about Avonex®3

Avonex® can cause serious side effects, so before you start taking Avonex®, you should talk with your doctor about the possible benefits of Avonex® and its possible side effects to decide if Avonex® is right for you.

Sometimes interferons, including Avonex®, make people feel sad. If you are taking Avonex®, and feel unusually sad, you should tell a family member or friend right away and call your doctor as soon as possible.

Your liver may be affected by taking Avonex® and a few patients have developed severe liver injury. Your healthcare provider may ask you to have regular blood tests to make sure that your liver is working properly. If your skin or the whites of your eyes become yellow or if you are bruising easily you should call your doctor immediately.

Some people have had severe allergic reactions, a drop in their red or white blood cell levels, heart problems, changes in their thyroid function, or seizures.

Avonex® has not been studied in pregnant women. If you become pregnant while taking Avonex®, you should stop taking Avonex® immediately, tell your doctor, and consider enrolling in the Avonex® Pregnancy Registry by calling 1-800-456-2255.

Most people who take Avonex® have flu-like symptoms (fever, chills, sweating, muscle aches, and tiredness) early during the course of therapy. For many people, these symptoms lessen or go away over time. Talk to your doctor if these symptoms continue longer than the first few months of therapy, or if they are difficult to manage.

06223563/060777

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References:
  1. Avonex® prescribing information, 03/05. Biogen Idec.
  2. FDA Web site. Available at: http://www.fda.gov/cder/handbook/categc.htm. Accessed August 1, 2006.
  3. Avonex® Website. Available at: http://www.avonex.com/msavProject/avonex.portal/_baseurl/splashLayout/SCSRepository
    /en_US/avonex/includes/important_safety_info.xml&island=true&portal=avonex
    . Accessed August 1, 2006.

Avonex® is a registered trademark of Biogen Idec.