TYSABRI- natalizumab injection 
Elan Pharmaceuticals, Inc.

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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?

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.

TYSABRI is only:

Who should not receive TYSABRI?

Do not receive TYSABRI if you:

TYSABRI is not recommended if you:

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:

How do I receive TYSABRI?

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:

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 arm 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?

Active ingredient: natalizumab

Inactive Ingredients: sodium chloride, sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; polysorbate 80, and water for injection.

Manufactured by Biogen Idec Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

I61061-17
Revised 12/2012

Manufactured by: Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142 USA
Distributed by: Elan Pharmaceuticals, Inc., South San Francisco, CA 94080

TYSABRI® is a registered trademark of Elan Pharmaceuticals, Inc.

TOUCH® is a registered trademark of Elan Pharmaceuticals, Inc.

Revised: 12/2012
 
Elan Pharmaceuticals, Inc.