Tysabri - Frequently Asked Questions 3 of 3
Q. Where can I call to get more information about Tysabri?
The Tysabri Care Program is a registry that supports the safe and effective use of Tysabri. Its goals are to:
· To inform people about the risks and benefits of Tysabri prior to treatment
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· To monitor individual safety on an ongoing basis
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· To provide educational materials on Tysabri for people with MS and for health care providers
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· To assist people with Tysabri reimbursement access
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· To provide a network of approved infusion centres across Canada
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Everyone who is enrolled in the Tysabri Care Program will be assigned a Personal Case Manager. Personal Case Managers will help individuals to schedule the initial appointment at an approved infusion centre, streamline the insurance process, and answer any questions related to Tysabri infusions.
For more information on Tysabri or the Tysabri Care Program, please call 1-888-827-2827.
Safety Concerns About Tysabri
Q. What is the primary safety concern regarding the use of Tysabri?
A. A primary safety issue is the fact that three people who had been in clinical trials involving Tysabri developed a rare disease called PML (progressive multifocal leukoencephalopathy), caused by a common virus called the JC virus. Two of them died, including one woman who had been diagnosed with MS (but whose diagnosis has since been called into question).
Q. If I take Tysabri, what are the risks that I will get PML?
A. No one knows the true risk of getting PML outside of the clinical trials of people taking Tysabri. According to a study published in The New England Journal of Medicine (The New England Journal of Medicine 2006;354:924-33), the risk in the clinical trials population, who had taken an average of 17.9 doses of Tysabri, is one in one thousand.
There is not enough known about the true risk of getting PML in people who may use Tysabri. For these and other reasons, Biogen Idec and Elan have developed procedures for the careful tracking of adverse events and has established a large observational study to help evaluate the long-term safety of Tysabri.
Q. Will I be safe if I take Tysabri alone, without any other drugs that alter the immune system?
A. No one knows. During the March 2006 advisory committee meeting held by the American FDA about Tysabri, FDA representatives stated that the risk of PML in those who took Tysabri alone versus those who took Tysabri in combination with Avonex is still unclear. That means that at this time there is insufficient data to determine whether PML was caused by taking Tysabri in combination with other immune-modulating drugs, or whether PML can arise in those taking Tysabri alone.
Q. Are there any tests that can be done to know in advance whether you are at risk for developing PML?
A. No.
Q. Are there any tests that can be done to know if you are developing PML?
A. Yes. If a person begins to show persistent signs of new or worsening neurological symptoms, they would likely be taken off Tysabri. Then their doctor would likely begin tests of the blood and spinal fluid as well as obtain an MRI scan of the brain to help determine whether the JC virus that causes PML is present and active.
Q. What are the signs of PML that a person using Tysabri should look out for?
A. All of this will be clearly explained in information that will be supplied to individuals before they begin taking Tysabri. People will be cautioned to inform their prescribing physicians and/or infusion nurse if they experience any new or worsening neurological symptoms. These might include any changes in thinking, eyesight, balance, strength and other symptoms.
Q. What is the treatment for PML?
A. There is at present no drug that has been proven to fight the JC virus. Therefore, treatment consists of reconstituting the immune system by withdrawing any immune-suppressing therapies.
Q. Are there risks of getting other serious infections if I take Tysabri?
A. The clinical trials of Tysabri in MS did not reveal significant differences in serious infections between those on active treatment versus those on inactive placebo. However, the risks of longer-term exposure to Tysabri are currently unknown.
Q. I read that in the US the FDA has included a "Black Box Warning" on Tysabri's label. What does that mean?
A. According to the FDA, a Black Box Warning is " the most serious warning placed in the labelling of a prescription medication... Black box warnings are designed to highlight special problems, particularly those that are serious, and to give health care professionals a clear understanding of a potential medical complication associated with a drug. Black box warnings provide physicians with important insights as to how to prescribe a drug that may be associated with serious side effects in a way that maximizes its benefits and minimizes its risks."
The Black Box Warning for Tysabri warns of the increased risk of PML and the importance of monitoring people using the drug for any new sign or symptoms that may be suggestive of PML.
Q. Are any other side effects possible if I'm taking Tysabri?
A. Yes. These will be detailed in the materials prepared by the drug's sponsors. In a two-year clinical trial of Tysabri alone, some of the adverse events reported significantly more frequently in those on Tysabri included fatigue, allergic reaction, and hypersensitivity reactions. In a two-year clinical trial of Tysabri in combination with Avonex, adverse events experienced significantly more often in those on combination therapy included anxiety, sore throat, sinus congestion and peripheral edema (swelling). In addition, two cases of PML, one of which was fatal, were diagnosed in those on combination therapy.
Q. What will the MS Society of Canada do if additional people die or experience serious side effects after taking Tysabri?
A. The use of Tysabri carries with it the risk of developing PML, an often fatal disease, and its use for extended periods of time carries unknown risks. If there are new cases, the MS Society of Canada will disseminate information as it becomes available. If the risk for PML or other serious adverse events were to significantly rise in clinical use, The MS Society of Canada would advocate that Health Canada take immediate and appropriate action.
Multiple Sclerosis Society of Canada
Toll free to reach the nearest regional office: 1 800 268-7582
Updated April 13, 2007