MEDICATION GUIDE
TYSABRI® (tie–SA–bree)
(natalizumab)
Read the Medication Guide given to you before you
start TYSABRI 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?
• TYSABRI 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
T YSABRI alone to treat your MS or CD, you can still
get PML.
• Your chance of getting PML increases:
- with a longer period of T YSABRI treatment
- if you have received medicines that can weaken
your immune system prior to starting TYSABRI.
• TYSABRI is available only through a restricted
distribution program called the TOUCH® Prescribing
Program. In order to receive TYSABRI, 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.
2. Adult patients with moderate to severe Crohn’s
disease:
- To reduce signs and symptoms of Crohn’s
disease.
- In patients who have not been helped
enough by, or cannot tolerate usual Crohn’s
disease medicines and medicines called tumor
necrosis factor (TNF) inhibitors.
• T YSABRI does not cure MS or Crohn’s disease.
• T YSABRI has not been studied for use longer than
2 years.
• TYSABRI has not been studied in patients with
chronic progressive MS.
• It is not known if patients older than 65
years have a different response to T YSABRI.
• T YSABRI is not approved for use in patients
under age 18.
TYSABRI is only:
• prescribed by doctors who are enrolled in the
TOUCH® Prescribing Program
• infused at an infusion center that is enrolled in the
TOUCH® Prescribing Program
• given to patients who are enrolled in the TOUCH®
Prescribing Program
Who should not receive TYSABRI?
Do not receive TYSABRI if you:
• have PML
• are allergic to TYSABRI
TYSABRI is not recommended if you:
• have a medical condition that can weaken your
immune system such as HIV infection or AIDS,
leukemia or lymphoma, or an organ transplant,
and others.
• are taking medicines that can weaken your
immune system. Talk with your doctor about all of
the medicines you take or have taken.
If you have questions about any of the above, talk to
your doctor.
What should I tell my doctor and nurse before
receiving each infusion of TYSABRI?
Tell your doctor and nurse about all of your medical
conditions. Tell them if you:
• have 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 several days
• have had hives, itching or trouble breathing during
or after an infusion of TYSABRI
• have a fever or infection (including shingles or any
unusually long lasting infection)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.
TYSABRI can pass into your milk. It is not known
if the T YSABRI that passes into breast milk can
harm your baby
Tell your doctor and nurse about all of the
medicines you are taking, including prescription and
non-prescription medicines, vitamins and herbal
supplements.
• Know the medicines you take. Keep a list of them
with you to show your doctor and nurse. The nurse
may ask to see this list before every T YSABRI
infusion.
How do I receive TYSABRI?
• T YSABRI is given once every four weeks through a
needle placed in a vein (IV infusion).
• You must follow all the instructions of the TOUCH®
Prescribing Program. Before you can begin to
receive TYSABRI, your doctor or nurse will:
- explain the TOUCH® Prescribing Program
to you
- have you sign the TOUCH® Prescriber/Patient
Enrollment Form
• Before every T YSABRI infusion you will be asked a
series of questions to confirm that TYSABRI is still
right for you.
• Call your doctor who prescribes T YSABRI right away
to report any medical problems that keep getting
worse and last several days.
What are the possible side effects of TYSABRI?
TYSABRI 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 TYSABRI include:
• Infections. TYSABRI 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. TYSABRI 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 TYSABRI.
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.TYSABRI.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.
I61061-11
Revised 03/2011
