Brief Summary of Product
information
What is the most important information I
should know about Rebif?
Rebif 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. Rebif can cause serious side
effects, so before you start taking Rebif, you should talk
with your doctor about the possible benefits of Rebif and
its possible side effects to decide if Rebif is right for you.
Potential serious side effects include:
•;depression. Some patients treated with interferons,
including Rebif, have become seriously depressed
(feeling sad). Some patients have thought about
killing themselves and a few have committed suicide.
Depression (a sinking of spirits or sadness) is not
uncommon in people with multiple sclerosis. However,
if you are feeling noticeably sadder or helpless, or feel
like hurting yourself or others you should tell a family
member or friend right away and call your doctor as
soon as possible. Your doctor may ask that you stop
using Rebif. You should also tell your doctor if you have
ever had any mental illness, including depression, and if
you take any medications for depression.
•;Liver problems. Your liver may be affected by taking
Rebif, 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 right away.
•;risk to pregnancy. If you become pregnant while
taking Rebif you should stop using Rebif immediately
and call your doctor. Rebif 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 Rebif is greater than the
risks to your unborn child.
•;allergic reactions. Some patients taking Rebif have
had severe allergic reactions leading to difficulty
breathing, and loss of consciousness. Allergic reactions
can happen after your first dose or may not happen
until after you have taken Rebif many times. Less severe
allergic reactions such as itching, flushing or skin bumps
can also happen at any time. If you think you are having
an allergic reaction, stop using Rebif immediately and
call your doctor.
•;injection site problems. Rebif may cause redness,
pain or swelling at the place where an injection was
given. A few patients have developed skin infections or
areas of severe skin damage (necrosis). If one of your
injection sites becomes swollen and painful or the area
looks infected and it doesn’t heal within a few days, you
should call your doctor.
What is Rebif?
Rebif is a type of 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 Rebif works in MS is not known.
Who should not take Rebif?
do not take rebif if you:
•;have had an allergic reaction such as difficulty breathing,
flushing or hives to another interferon beta or to human
albumin.
If you have any of the following conditions or serious
medical problems, you should tell your doctor before
taking Rebif:
• Depression (a sinking feeling or sadness), anxiety
(feeling uneasy or fearful for no reason), or trouble
sleeping
•;Liver diseases
•;Problems with your thyroid gland
•;Blood problems such as bleeding or bruising easily and
anemia (low red blood cells) or low white blood cells
•;Epilepsy
•;Are planning to become pregnant
Tell your doctor about all medicines you take, including
prescription and non-prescription medicines, vitamins and
herbal supplements. Rebif and other medicines may affect
each other causing serious side effects. Talk to your doctor
before you take any new medicines.
How should I take Rebif?
Rebif is given by injection under the skin (subcutaneous
injection) on the same three days a week (for example,
Monday, Wednesday and Friday). Your injections should
be at least 48 hours apart so it is best to take them the
same time each day. Your doctor will tell you what dose
of Rebif to use, and may change the dose based on how
your body responds. You should not change the dose
without talking with your doctor.
If you miss a dose, you should take your next dose as
soon as you remember or are able to take it, then skip the
following day. do not take rebif on two consecutive
days. You should return to your regular schedule the
following week. If you accidentally take more than your
prescribed dose, or take it on two consecutive days, call
your doctor right away.
You should always follow your doctor’s instructions and
advice about how to take this medication. If your doctor
feels that you, or a family member or friend may give you
the injections, then you and/or the other person should
be trained by your doctor or healthcare provider in how
to give an injection. Do not try to give yourself (or have
another person give you) injections at home until you (or
both of you) understand and are comfortable with how to
prepare your dose and give the injections.
always use a new, unopened, prefilled syringe of
rebif for each injection. never reuse syringes.
It is important that you change your injection site each
time Rebif is injected. This will lessen the chance of your
having a serious skin reaction at the spot where you inject
Rebif. You should always avoid injecting Rebif into an
area of skin that is sore, reddened, infected or otherwise
damaged. Your doctor, nurse, or other healthcare
provider should train you and/or your care partner to give
subcutaneous injections using the Rebif prefilled syringe.
The Rebiject II autoinjector, a handheld mechanical device,
can also be used.
What should I avoid while taking Rebif?
•;Pregnancy. You should avoid becoming pregnant while
taking Rebif until you have talked with your doctor.
Rebif can cause you to lose your baby (miscarry).
•;Breast feeding. You should talk to your doctor if
you are breast feeding an infant. It is not known if
the interferon in Rebif can be passed to an infant in
mother’s milk, and it is not known whether the drug
could harm the infant if it is passed to an infant.
•;rebif and other medicines may affect each other
causing serious side effects. Talk to your doctor
before taking any new medicines.
What are the possible side effects of Rebif?
•flu-like symptoms. Most patients have flu-like
symptoms (fever, chills, sweating, muscle aches and
tiredness). For many patients, these symptoms will
lessen or go away over time. You should talk to your
doctor about whether you should take an over-the-counter medication for pain or fever reduction before
or after taking your dose of Rebif.
•;Skin reactions. Soreness, redness, pain, bruising or
swelling may occur at the place of injection.
•depression and anxiety. Some patients taking
interferons have become very depressed and or anxious.
There have been patients taking interferons who have
had thoughts about killing themselves. If you feel sad or
hopeless you should tell a friend or family member right
away and call your doctor immediately.
•;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.
•;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 drops 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.
•;thyroid problems. Your thyroid function may change.
Symptoms of changes in the function of your thyroid
include feeling cold or hot all the time, or a change in
your weight (gain or loss) without a change in your diet
or amount of exercise you are getting.
•;allergic reactions. Some patients have had hives, rash,
skin bumps or itching while they were taking Rebif.
Other patients have had more serious allergic reactions
such as difficulty breathing or feeling light-headed. You
should tell your doctor if you think you are having an
allergic reaction.
Whether you experience any of these side effects or
not, you and your doctor should periodically talk about
your general health. Your doctor may want to monitor
you more closely and ask you to have blood tests done
more frequently. Call your doctor for medical advice
about side effects. You may report side effects to FDA at
1-800-FDA-1080.
For more information, please refer to the Rebif Medication
Guide and Rebif Full Prescribing Information, and talk
to your doctor. You can also visit www.Rebif.com or
www.MSLifeLines.com or call toll free 1-877-44-REBIF
(1-877-447-3243).
manufactured by:
emd Serono, inc.
rockland, ma 02370
u.S. License 1773
co-marketed by:
emd Serono, inc.
rockland, ma 02370
Pfizer inc.
new york, ny 10017
Rebif® is a registered trademark and Rebiject II™ is a
trademark of EMD Serono, Inc.
© 2011 EMD Serono, Inc. 110711-145743 09/09
All rights reserved. Printed in USA
