Avonex


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:
âEUR¢ Depression – Some people treated with interferons, including AVONEX®, have
become depressed (feeling sad, feeling low or feeling bad about oneself). Some
people have had thoughts 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.
âEUR¢ 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.
âEUR¢ 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.
âEUR¢ 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.
âEUR¢ 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.

âEUR¢ 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
âEURoeWhat are the possible side effects of AVONEX®?âEUR in this Medication Guide.

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.
Who should not take AVONEX®?
Do not take AVONEX® if you:
âEUR¢ have had an allergic reaction (difficulty breathing, itching, flushing or skin
bumps spread widely over the body) to interferon beta or to human albumin
If you have ever had any of the following conditions or serious medical problems,
you should tell your doctor before taking AVONEX®:
âEUR¢ Depression (sinking feeling or sadness), anxiety (feeling uneasy or fearful
for no reason), or trouble sleeping
âEUR¢ Problems with your thyroid gland
âEUR¢ Blood problems such as bleeding or bruising easily and anemia (low
red blood cells) or low white blood cells
âEUR¢ Seizures (for example, epilepsy)
âEUR¢ Heart problems
âEUR¢ Liver disease
âEUR¢ Are planning to become pregnant

You should tell your doctor if you are taking any other prescription or
nonprescription medicines. This includes any vitamin or mineral supplements, or
herbal products.

recommend that you take a medication to treat your depression. (See
âEURoeWhat is the most important information I should know about
AVONEX®?âEUR)
âEUR¢ 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 âEURoeWhat is the most important information I should
know about AVONEX®?âEUR)
âEUR¢ Liver problems – Your liver function may be affected. Symptoms of changes
in your liver include yellowing of the skin and whites of the eyes and easy
bruising
âEUR¢ 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.
âEUR¢ 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 âEURoeWhat is the most important
information I should know about AVONEX®?âEUR)
âEUR¢ Heart problems âEUR” 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 âEURoeWhat is the most
important information I should know about AVONEX®?âEUR)
If you get any of the symptoms listed in this section or any listed in the section âEURoeWhat
is the most important information I should know about AVONEX®?âEUR, 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.


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