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). Even if you use TYSABRI
alone to treat your MS or CD, you can still get
PML.
• Your chance of getting PML increases with a
longer period of treatment or if you have received
medicines that can weaken your immune system
prior to starting TYSABRI. However, PML is a rare
event.
• 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.
• If you get PML, your doctor will monitor you for
certain new or worsening symptoms that can
happen suddenly after you get PML. Contact your
doctor right away if you think your general health
status is getting worse. Your doctor may
diagnose you as having Immune Reconstitution
Inflammatory Syndrome (IRIS) and treat you for
these symptoms if they happen. Failure to treat
these symptoms can lead to serious
complications or death.
Also, 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, TYSABRI 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.
- Patients should not be taking certain
medicines that weaken the immune system
at the same time they are taking TYSABRI.
Ask your doctor if you have questions.
• TYSABRI does not cure MS or Crohn’s
disease.
• TYSABRI has not been studied for use longer
than 2 years. Also, 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 TYSABRI.
• TYSABRI 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
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
TYSABRI infusion.
How do I receive TYSABRI?
• TYSABRI 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 TYSABRI infusion you will be asked
a series of questions to confirm that TYSABRI is
still right for you.
• 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 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:
• 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.
• Infections. TYSABRI may increase your chance of
getting an unusual or serious infection because
TYSABRI can affect your immune system.
• 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 TYSABRI. 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 TYSABRI. 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?
Each dose of TYSABRI contains natalizumab;
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.
I61061-10
07/10
Manufactured by: Biogen Idec Inc.,
14 Cambridge Center, Cambridge, MA 02142 USA
Distributed by: Elan Pharmaceuticals, Inc., South
San Francisco, CA 94080
TYSABRI® and Touch® are registered trademarks of
Elan Pharmaceuticals, Inc.
