MEDICATION GUIDE
TYSABRI® (tie–SA–bree)
(natalizumab)
Read the Medication Guide given to you before you
start T YSABRI and before each infusion. There may
be new information. This Medication Guide does not
take the place of talking to your doctor about your
medical condition or your treatment. Ask your doctor
or nurse if you have any questions.
What is the most important information I
should know about TYSABRI?
• T YSABRI increases your chance of getting a rare
brain infection that usually causes death or
severe disability. This infection is called
progressive multifocal leukoencephalopathy
(PML). If PML happens, it usually happens in
people with weakened immune systems.
• No one can predict who will get PML.
• There is no known treatment, prevention, or cure
for PML.
• Your chance of getting PML may be higher if you
are also being treated with other medicines that
can weaken your immune system, including other
treatments for Multiple Sclerosis (MS) and Crohn’s
disease (CD). You should not take certain
medicines that weaken the immune system at the
same time you are taking TYSABRI. Even if you
use TYSABRI alone to treat your MS or CD, you
can still get PML.
• Your chance of getting PML increases if you have
been exposed to JCV. JCV is a common virus that
is harmless in most people but can cause PML in
people who have weakened immune systems,
such as people taking Tysabri. Most people who
are exposed to JCV do not know it or have any
symptoms. This exposure usually happens in
childhood.
• If you have been exposed to JCV, your chance of
getting PML increases even more if:
- You have received TYSABRI for a long time,
especially longer than 2 years
- You have received certain medicines that can
weaken your immune system before you start
receiving TYSABRI.
Your doctor may do a blood test to check if you
have been exposed to JCV before you start
receiving T YSABRI or during your treatment. There
may be other risk factors for getting PML during
Tysabri treatment that we do not know about yet.
• Your risk of getting PML is greatest if you have all 3
risk factors listed above. Your doctor should
discuss the risks and benefits of T YSABRI treatment
with you before you decide to receive T YSABRI.
• TYSABRI is available only through a restricted
distribution program called the TOUCH® Prescribing
Program. In order to receive T YSABRI, you must
talk to your doctor and understand the benefits
and risks of TYSABRI and agree to all of the
instructions in the TOUCH® Prescribing Program.
• If you take TYSABRI, it is important that you call
your doctor right away if you get any new or
worsening medical problems (such as a new or
sudden change in your thinking, eyesight, balance,
or strength or other problems) that have lasted
over several days. Tell all of your doctors that you
are getting treatment with TYSABRI.
See “What are the possible side effects with
TYSABRI?” for other serious side effects with
TYSABRI.
What is TYSABRI?
TYSABRI is a prescription medicine approved for:
1. Adult patients with relapsing forms of Multiple
Sclerosis (MS) to:
- Slow the worsening of disability that is
common in patients with MS and,
- Decrease the number of flare-ups (relapses)
Because of the chance of getting PML, T YSABRI is
generally recommended for patients that have not
been helped enough by, or cannot tolerate another
treatment for MS.
• Call your doctor who prescribes TYSABRI right away
to report any medical problems that keep getting
worse and last several days.
What are the possible side effects of T YSABRI?
T YSABRI increases your chance of getting a rare
brain infection that usually causes death or severe
disability. This infection is called progressive
multifocal leukoencephalopathy (PML). If PML
happens, it usually happens in people with weakened
immune systems. (see “What is the most important
information I should know about TYSABRI?”)
Other serious side effects with T YSABRI include:
• Infections. T YSABRI may increase your chance of
getting an unusual or serious infection because
TYSABRI can weaken your immune system.
• Allergic reactions including serious allergic
reactions. Symptoms can include:
- hives - chills
- itching - rash
- trouble breathing - nausea
- chest pain - flushing of skin
- dizziness - low blood pressure
- wheezing
• Serious allergic reactions usually happen within 2
hours of the start of the infusion, but they can
happen at any time after receiving TYSABRI.
• Tell your doctor or nurse right away if you have any
symptom of an allergic reaction, even if it happens
after you leave the infusion center. You may need
treatment if you are having an allergic reaction.
• Liver damage. T YSABRI may cause liver
damage. Symptoms can include:
- yellowing of the skin - unusual darkening
and eyes (jaundice) of the urine
- nausea - feeling tired or weak
- vomiting
Blood tests can be done to check for liver
damage. Call your doctor right away if you have
symptoms of liver damage.
Other side effects with TYSABRI include:
- headache - feeling tired
- urinary tract infection - joint pain
- lung infection - depression
- pain in your arms and legs - diarrhea
- vaginitis - rash
- nose and throat infections - stomach area pain
Tell your doctor about any side effect that bothers you
or that does not go away. These are not all the side
effects with T YSABRI. Ask your doctor for more
information.
General information about the safe and effective
use of T YSABRI.
This Medication Guide provides a summary of the
most important information about T YSABRI. If you
would like more information or have any questions,
talk with your doctor or nurse. You can ask your
doctor or nurse for information about TYSABRI that is
written for healthcare professionals. You can also call
1-800-456-2255 or visit www.T YSABRI.com.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at
1-800-FDA-1088.
What are the ingredients in TYSABRI?
Active ingredient: natalizumab
Inactive Ingredients: sodium chloride, sodium
phosphate, monobasic, monohydrate; sodium
phosphate, dibasic, heptahydrate; polysorbate 80,
and water for injection.
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
Distributed by: Elan Pharmaceuticals, Inc., South San
Francisco, CA 94080
T YSABRI® and Touch® are registered trademarks of
Elan Pharmaceuticals, Inc.
I61061-14
Revised 01/2012
