Drugs, Devices & Supplements
What is TYSABRI® (natalizumab)?
TYSABRI is a drug to treat adults with certain forms of multiple
sclerosis (MS) and Crohn's disease. The drug is approved for relapsing forms of
MS and moderate to severe forms of Crohn's. The drug does not cure either of
these diseases. TYSABRI has been shown to cut down on the number or frequency of
flare-ups (relapses) of MS, has slowed the progression of the progression of the
disease and on the development of new brain lesions. The lesions of multiple
sclerosis are visible on magnetic resonance imaging (MRI) tests.
Who can use TYSABRI?
Your doctor may prescribe TYSABRI if you are an adult with a
relapsing form of MS who has not been helped enough by other MS treatments, or
an adult who is not able to tolerate other forms of MS drugs. In addition, no
patient will receive TYSABRI unless they have enrolled in the TOUCH™ Prescribing Program.
How is TYSABRI given?
TYSABRI is a drug given through intravenous infusion, or through
a needle placed in a vein. It is given one time every four weeks. The treatment
takes about an hour.
Before each time that you get TYSABRI, you must answer a series
of questions that will determine whether or not TYSABRI is right for you. These
questions will cover medications that you may have taken and details of your physical health.
What is the TOUCH (TYSABRI Outreach: Unified Commitment to Health) Program?
For TYSABRI usage, the patient, the doctor, and the infusion
center must ALL be enrolled in the program. TOUCH has patient safety as its
focus and was developed with the aid of the US Food and Drug Administration.
The TOUCH program is in place because of the link between
TYSABRI and the development of progressive multifocal leukoencephalopathy (PML).
PML is rare, but is a brain infection that usually results in the death or
severe disability. If PML occurs, it usually happens when a person has a weak
immune system. Currently, there is no cure, prevention, or treatment for PML.
- Your chance of getting PML is increased if you are taking other
immune-system-compromising treatments for Crohn's disease or MS with TYSABRI.
- It is not known whether or not taking TYSABRI alone will reduce the
chance of developing PML.
- It is also not known whether or not you will have a higher risk after
taking TYSABRI for a long period of time.
- TYSABRI has not been studied for periods of time longer than two years.
- In addition, it has not been studied for use in treating progressive MS without relapses.
- It is not known if patients who are older than 65 years old may have
different reactions to TYSABRI.
- TYSABRI is not approved for patients younger than 18 years old.
Before you can get TYSABRI, you must talk with your doctor so
that you understand the benefits and risks of the drug. You must also agree to
follow the directions given in the TOUCH program. You must also call your health
care provider immediately if you develop any new medical problems, or if
existing problems get worse.
The TOUCH program will also require that you see your doctor at
specified times--particularly at 3 months, and then every six months--after
starting TYSABRI. You will also have a case manager who has been trained in the
program and who will be able to answer questions on the therapy. They will also
be able to provide information on insurance, financial aid, and locations of
authorized infusion centers in your area.
What side effects are possible with TYSABRI?
The most significant risk is the chance of developing
progressive multifocal leukoencephalopathy (PML), a brain infection that usually
causes death or severe disability. In addition to the risk of PML, there are
other side effects possible with TYSABRI. These include:
Allergic reactions, including serious allergic reactions.
Serious reactions generally will occur within 2 hours from the time that you
start receiving TYSABRI, but may develop at any time after you get the drug. You
should always notify your health care provider if you have any type of allergic
reaction, even if you have already left the infusion site. Symptoms of these
types of reactions include:
Infections. Infections, including serious or unusual
infections, are possible due to the effect of TYSABRI on your immune system.
Other types of possible infections are urinary tract infections, lung
infections, and vaginitis.
Other side effects are possible, including:
You should tell your health care provider about any type of side
effect that happens, that bothers you, or that does not go away. This is not a
complete list of side effects; you should check with your doctor for more
Who should not take TYSABRI?
You should not take TYSABRI if you have PML or are allergic to
TYSABRI. In addition, TYSABRI is not recommended for people who:
- Have a medical condition that can result in a weakened immune system.
These conditions include HIV infection, AIDS, leukemia, lymphoma, and
others. TYSABRI is also not recommended for organ transplant recipients.
- Are currently taking medications that can weaken your immune system.
- Are pregnant, nursing, or trying to become pregnant.
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This information is provided by the Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition. This document was last reviewed on: 12/15/2012…#14123