Brief Summary of Medication Guide
Avonex® (a-vuh-necks)
Interferon beta-1a (in-ter-feer-on beta-one-a)
Please read this guide carefully before you start to use
AVONEX and each time your prescription is refilled since
there may be new information. The information in this
guide does not take the place of talking with your doctor
or healthcare professional.
What is the most important information I should know
about AVONEX?
AVONEX will not cure multiple sclerosis (MS) but it has
been shown 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 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. Potential serious side effects
include:
• Depression - Some people treated with interferons,
including AVONEX, have become depressed (feeling
sad, feeling low or feeling bad about oneself). Some
people have thought about killing themselves and a
few have committed suicide. Depression is common in
people with MS. If you are noticeably sadder or feeling
more hopeless, you should tell a family member or
friend right away and call your doctor as soon as
possible. You should tell the doctor if you have ever had
any mental illness, including depression, and if you take
any medicines for depression.
• Liver problems - 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.
• Risk to pregnancy - If you become pregnant while
taking AVONEX, you should stop using AVONEX
immediately and call your doctor. AVONEX may cause
you to lose your baby (miscarry) or may cause harm to
your unborn child. You and your doctor will need to
decide whether the potential benefit of taking AVONEX
is greater than the risks are to your unborn child.
• Allergic reactions - Some patients taking AVONEX
have had severe allergic reactions leading to difficulty
breathing. Allergic reactions can happen after your first
dose or may not happen until after you have taken
AVONEX many times. Less severe allergic reactions
such as rash, itching, skin bumps or swelling of the
mouth and tongue can also happen. If you think you
are having an allergic reaction, stop using AVONEX
immediately and call your doctor.
• Blood problems - You may have a drop in the levels of
infection-fighting blood cells, red blood cells or cells
that help to form blood clots. If the drop in levels are
severe, they can lessen your ability to fight infections,
make you feel tired or sluggish or cause you to bruise
or bleed easily.
• Seizures - Some patients have had seizures while taking
AVONEX, including some patients who have never had
seizures before. It is not known whether the seizures
were related to the effects of their MS, to AVONEX, or
to a combination of both. If you have a seizure while
taking AVONEX, you should stop taking AVONEX and
call your doctor right away.
• Heart problems - While AVONEX is not known to
have 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. Some of the symptoms of heart problems are
swollen ankles, shortness of breath, decreased ability to
exercise, fast heartbeat, tightness in chest, increased
need to urinate at night, and not being able to lay flat
in bed. If you develop these symptoms or any heart
problems while taking AVONEX, you should call your
doctor right away.
What is AVONEX?
AVONEX is a form of a protein called beta interferon that
occurs naturally in the body. It is used to treat relapsing
forms of multiple sclerosis. It 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.
Usually, these symptoms last for a day after the injection.
You may be able to manage these flu-like symptoms by
injecting your AVONEX dose at bedtime and taking over-the-counter pain and fever reducers. 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.
• Depression - Some patients taking interferons have
become severely depressed and/or anxious. If you
feel sad or hopeless you should tell a friend or family
member right away and call your doctor immediately.
Your doctor or healthcare provider may ask that you
stop taking AVONEX, and/or may recommend that you
take a medication to treat your depression. (See “What
is the most important information I should know about
AVONEX?”)
• Liver problems - Your liver function may be affected.
If you develop symptoms of changes in your liver,
including yellowing of the skin and whites of the eyes
and easy bruising, call your doctor immediately. (See
“What is the most important information I should
know about AVONEX?”)
• Blood problems - A drop in the levels of white
(infection-fighting) blood cells, red blood cells, or a part
of your blood that helps to form blood clots (platelets)
can happen. If this drop in blood levels is severe, it can
lessen your ability to fight infections, make you feel
very tired or sluggish, or cause you to bruise or bleed
easily. Your doctor may ask you to have periodic blood
tests. (See “What is the most important information I
should know about AVONEX?”)
• Thyroid problems - Some people taking AVONEX
develop changes in the function of their thyroid.
Symptoms of these changes include feeling cold or
hot all the time, a change in your weight (gain or loss)
without a change in your diet or amount of exercise you
get, or feeling emotional.
• Seizures - Some patients have had seizures while
taking AVONEX, including patients who have never had
seizures before. It is not known whether the seizures
were related to the effects of their MS, to AVONEX, or
to a combination of both. If you have a seizure while
taking AVONEX, you should call your doctor right
away. (See “What is the most important information I
should know about AVONEX?”)
• Heart problems - 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. Some of the symptoms of heart problems are
swollen ankles, shortness of breath, decreased ability to
exercise, fast heartbeat, tightness in chest, increased
need to urinate at night, and not being able to lay flat
in bed. If you develop these symptoms or any heart
problems while taking AVONEX, you should call your
doctor right away. (See “What is the most important
information I should know about AVONEX?”)
If you get any of the symptoms listed in this section or
any listed in the section “What is the most important
information I should know about AVONEX?”, you should
call your doctor right away. Whether you experience any
side effects or not, you and your doctor should periodically
discuss your general health. Your doctor may want to
monitor you more closely or may ask you to have blood
tests more frequently.
General advice about prescription medicines
Medicines are sometimes prescribed for purposes other
than those listed in a Medication Guide. This medication
has been prescribed for your particular condition. Do not
use it for another condition or give this drug to anyone
else. If you have questions you should speak with your
doctor or healthcare professional. You may also ask
your doctor or pharmacist for a copy of the information
provided to them with the product.
Keep this and all drugs out of the reach of children.
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Manufactured By:
Biogen Idec, Inc.
14 Cambridge Center
Cambridge, MA 02142 USA
©2006 Biogen Idec Inc. All rights reserved.
1-800-456-2255
