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 orsevere 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:
- Skin reactions, including itching, hives, rash, or flushing
- Difficulty breathing
- Chest pain
- Low blood pressure
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:
- Pain in your limbs (arms and legs)
- Pain in your joints
- Pain in the stomach area
- Liver irritation
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 information.
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.