Tysabri

 

TYSABRI®

[NATALIZUMAB]

Tysabri® belongs to a class of drugs known as immunomodulators. Tysabri® is a synthetic form of antibody called natalizumab, made by Biogen Idec Inc. Natalizumab is a type of antibody that blocks the autoimmune action of your body responsible for attacking nerves in your brain.

Tysabri® is currently FDA-approved for treating relapsing forms of multiple sclerosis (MS) and moderate to severe Crohn’s Disease. Clinical studies show that Tysabri® reduces signs and symptoms of MS by decreasing the

number of flare-ups and slows progression of MS symptoms.

Tysabri® is given as an intravenous infusion. Tysabri® requires a valid prescription and is only available under a special restricted distribution program called TOUCH® Prescribing Program. Ocean Breeze Healthcare can provide Tysabri® as well as supplies you would need to administer the drug.

What form is Tysabri® currently available?

Tysabri® is currently only available as a single-use vial.

The single-use vial is formulated as 300 mg natalizumab in 15 mL solution for intravenous infusion.

What are some potential side effects of Tysabri®?

Common side effects with Tysabri® include, but are not limited to, infusion reactions such as rash, itchiness or dizziness. Some of the other possible side effects are headache, fatigue. On rare occasions, the medication can cause a rare and potentially life-threatening brain infection called progressive multifocal leukoencephalopathy (PML).

If you are experiencing any unwanted side effect(s) or have any specific questions or concerns regarding a side effect, contact your doctor or pharmacist. You may also report the side effect(s) to the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.

Who should NOT use Tysabri®?

Tysabri® should be avoided if you have a history of progressive multifocal leukoencephalopathy (PML). Do not take Tysabri® if you have history of allergy and/or hypersensitivity to natalizumab, or to any other component of the formulation.

Speak to your doctor or pharmacist if you are pregnant or nursing.

How do you administer Tysabri®?

Tysabri® must be given as an intravenous infusion over an hour.

Tysabri® must be prepared and administered by professionals at a registered TOUCH® Prescribing Program infusion center. Prior to infusion, Tysabri® must be diluted into 100ml of normal saline solution.

How do you store Tysabri®?

Tysabri® should be stored at refrigerator (36° to 46° Fahrenheit) prior to dilution. DO NOT FREEZE. Protect from light.

After dilution, Tysabri® should be used immediately or may be refrigerated for up to 8 hours after preparation.

How long does Tysabri® last?

Before opening, Tysabri® is stable until the indicated expiration date listed on the packaging if all the required storage conditions are met. Once the vial is diluted in normal saline solution, it is stable for up to 8 hours under refrigeration. Each Tysabri® vial is intended for one-time use only; discard any unused drug after each dose.

Commonly Asked Questions

Q:    Does Tysabri® cure multiple sclerosis (MS)?
A:    No, Tysabri® is not a cure for MS. It simply relieves the symptoms associated with MS and may potentially             slow the progression of MS.

Q:    Are there any preservatives in Tysabri®?
A:     No, Tysabri® does not contain any preservatives.

Q:    How often do I take Tysabri®?
A:    In general, Tysabri® is administered every 4 weeks.

Manufacturer Website

http://www.tysabri.com/

Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional.  You should not use the information contained herein for diagnosing or treating a health problem or disease, or prescribing any medication.  You should read carefully all product packaging.  If you have or suspect that you have a medical problem, promptly contact your health care provider.

 
 

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