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How to Prescribe Natalizumab: Tysabri®

James Bowen, MD

Medical Director, Multiple Sclerosis Center

Swedish Neuroscience Institute

Seattle, WA

 

TysabriÒ 

  • Slows the course of multiple sclerosis when used regularly over long periods of time.
  • Does not improve existing symptoms.
  • Is not used to treat acute MS attacks.

 

Generic name: natalizumab

 

How supplied: Tysabri® comes in single-use vials that need dilution prior to infusion. These must be stored under refrigeration at 2-8° C. Once diluted, the medication should be used within 8 hours.  The medication must be prescribed through the Tysabri Outreach: Unified Commitment to Health (TOUCH™) program.

 

Initial dose: Titration of the initial dose is not necessary.

 

Maintenance dose: 300mg in 100cc normal saline intravenously once every 4 weeks. The medication is infused over one hour. Patients should be observed for an additional hour after infusion before discharge home.

 

Laboratory testing: Not required.

 

Side effects:

  • Infections: There is a slight increase in infections (2.1% in those treated with Tysabri® versus 1.3% in those on placebo).
  • Urticaria was seen in 2% of patients. If urticaria develops, the infusion should be immediately stopped, and the patient should be treated with diphenhydramine 10-25mg intravenously, subcutaneously, or orally. Tysabri® should not be used again in those who experience urticaria.
  • Flushing, in contrast to urticaria, does not need to be treated and is not a contraindication to continued use of Tysabri®
  • Anaphylaxis was seen in 0.8% of patients receiving Tysabri®. This is manifested by laryngeal edema with shortness of breath or wheezing. If these symptoms develop, the infusion should be immediately stopped, and the patients should be treated with epinephrine 1:1000, 0.3 – 0.5 cc, intramuscularly or subcutaneously. Epinephrine should not be given intravenously in this situation. Patients with anaphylaxis should be admitted to the hospital for overnight observation.

  • Progressive multifocal leukoencephalopathy (PML) is a viral infection that may be seen in those treated with Tysabri®. The current estimate is that 1/1000 people treated with Tysabri® will get PML. The most effective way to screen people for PML is to take careful note of neurological symptoms. The TOUCH program is designed to monitor patients for changes in their symptoms. If PML occurs, the diagnosis must be confirmed by MRI and cerebrospinal fluid examination. Treatment consists of discontinuing the Tysabri® and removing the medication with plasma exchange.

  • On August 15, 2012, the U.S. Food and Drug Administration (FDA) announced an additional change to the natalizumab (Tysabri) prescribing information. The updated label recommends that patients who have tested negative to the anti-JCV antibody test should be retested every six months. The repeat testing will help to identify anyone who has been exposed to the John Cunningham virus (JCV) since the previous testing. This, in turn, will help patients and their doctors make the best possible decisions about continuing treatment with natalizumab.

Company Support:   MS Active Source - 1-800-456-2255.

                                    www.MSActiveSource.com,   www.tysabri.com 

                                    TOUCH™ program 1-800-456-2255 www.touchprogram.com 

 

For More Information

Refer to the Health Care Professionals homepage of this website and review the forms that are required for monitoring patients on natalizumab.

 

 

 

Last Updated: October 2012