Brief Summary of Medication Guide
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
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
• 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.
For more information on possible side effects with
AVONEX, please read the section on "What are the
possible side effects of AVONEX?" in this Medication
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 sys-
tem by destroying the protective covering (myelin) that
surrounds your nerve fibers. The way AVONEX works in
MS is not known.
Who should not take AVONEX?
Do not take AVONEX if you have had an allergic reac-
tion (difficulty breathing, itching, flushing or skin bumps
spread widely over the body) to interferon beta.
Do not take the vial formulation of AVONEX if you have a
history of hypersensitivity to albumin (human).
If you have ever had any of the following conditions or
serious medical problems, you should tell your doctor
before taking AVONEX: