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TYSABRI® has helped many people who have relapsing MS. But it can also increase the
chance of getting a serious brain infection called PML, which usually causes death or
severe disability. It’s important to understand that there are 3 known risk factors for
PML — exposure to the virus that causes PML (the JC Virus), a longer period of TYSABRI
treatment (especially beyond 2 years), and the use of certain medications that weaken
the immune system. A blood test has been created that can help identify one of these
risk factors (the JC Virus). It’s important to remember that there may be other risk factors
for getting PML during TYSABRI treatment that we don’t know about yet. Also, you could
still be at risk, regardless of your test results. The administration of the test only takes
a few minutes. It could give you and your doctor the insight you need to make a more
informed decision about TYSABRI.
Learn more about the JC Virus Test at
www.TysabriTest.com. Then talk to your
doctor about the benefits and risks of TYSABRI.
disability and reduce number of flare-ups. Since TYSABRI increases the risk of PML, a rare
unable to tolerate or respond well to another therapy. See TYSABRI Risk Information below.
Tell all of your doctors that you are getting treatment with TYSABRI.
•;TYSABRI;is;available;only;through;the;TOUCH® Prescribing Program (TOUCH), which is a restricted distribution program.
Only prescribers, patients, and infusion centers enrolled in the TOUCH can prescribe, receive, and infuse TYSABRI. In order to
receive TYSABRI, you must talk to your doctor and agree to all of the instructions in the TOUCH.
•;You;should;not;receive;TYSABRI;if;you;have;PML;or;are;allergic;to;TYSABRI;or;any;of;its;ingredients.
•;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, organ transplant, or others, or if you are taking medicines that weaken your immune system.
•;Tell;your;doctor;about;all;of;the;medicines;you;take;or;have;taken.
•;Tell;your;doctor;if;you;are;pregnant;or;are;trying;to;become;pregnant;or;if;you;are;breastfeeding;or;plan;to;breastfeed.;TYSABRI
can pass into your breast milk. It is not known if the TYSABRI that passes into breast milk can harm your baby.
•;Serious;side;effects;with;TYSABRI;include;an;increase;in;your;chance;of;getting;an;unusual;or;serious;infection,;because;it;can
weaken your immune system.
•;Other;serious;side;effects;with;TYSABRI;include;allergic;reactions;(e.g.,;hives,;itching,;trouble;breathing,;chest;pain,;dizziness,
wheezing,;chills,;rash,;nausea,;flushing;of;skin,;low;blood;pressure),;including;serious;allergic;reactions;(e.g.,;anaphylaxis)
and infections. Serious allergic reactions usually happen within 2 hours of the start of the infusion, but can happen any time
after receiving TYSABRI. Tell your doctor or nurse right away if you have any symptom of an allergic reaction. You may need
treatment if you are having an allergic reaction.
• TYSABRI;may;cause;liver;damage.;Symptoms;of;liver;damage;include;yellowing;of;the;skin;and;eyes;(jaundice),;unusual
darkening of the urine, nausea, feeling tired or weak, or vomiting. Blood tests can be done to check for liver damage. Call
your doctor right away if you experience any symptoms of liver damage.
•;Common;side;effects;include;headache,;urinary;tract;infection,;lung;infection,;pain;in;your;arms;and;legs,;vaginitis,;stomach
area;pain,;feeling;tired,;joint;pain,;depression,;diarrhea,;and;rash.;Tell;your;doctor;about;any;side;effect;that;bothers;you;or
does not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch,
or call 1- 800-FDA-1088. Please see the brief summary of the patient medication guide on the following page.
