Multiple Sclerosis (MS) Support Group
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I just read in the Rocky Mountain Multiple Sclerosis Center that 2 people developed that PML from taking tysabri in July 2008. One person is stable, the other one is in the hospital with no further inforamtion. They are saying that 1 in 1,000 is getting the PML. I hate that. I dont' think i'm ever gonna try that.
Wouldn't it be great to hear first-hand about TYSABRI (natalizumab) therapy from people who are taking it? Well now you can. Introducing the TYSABRI Teleconference Series. Each month, real patients will share their personal experiences with youfrom what impact TYSABRI has had on their lives to managing side effects to how they receive infusions. In addition to a panel of patients, each teleconference is moderated by a healthcare professional. You'll have the opportunity to submit your own questions to the panel and have them answered live during the teleconference.
What type of questions can I ask?
Any question you may have about TYSABRI. Find out:
How will my doctor and I know if TYSABRI is right for me?
Where do I receive a TYSABRI infusion?
What are the side effects of TYSABRI therapy?
What is the TOUCH Prescribing Program?
When are the teleconferences held?
The TYSABRI teleconferences are 60 minutes in length and will be held on the following dates:
Date/Time Topic
Oct 16
7 PM ET
Meeting the Challenge of MS in your Relationships
Nov 6
7 PM ET
Having Happy Holidays While Living with MS
Nov 13
8 PM ET
What It's Like to Get TYSABRI
Dec 4
10 PM ET
Just the Facts: The Benefits and Risks of TYSABRI
Dec 11
7 PM ET
On the Job: MS at Work
How do I register for a teleconference?
Simply call 1-866-644-8540 10 minutes before the start of the teleconference. When asked for a code, please say, "Peer-to-Peer Teleconference."
TYSABRI is a prescription medicine approved for patients with relapsing forms of MS to slow the worsening of disability that is common in patients with MS and to decrease the number of flare-ups (relapses). Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. TYSABRI does not cure MS and has not been studied longer than two years or in patients with chronic progressive MS.
Important safety information
TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). PML usually happens in people with weakened immune systems. No one can predict who will get PML. Your chances may be higher if you are also being treated with medicines that weaken your immune system, including other MS treatments. If you use TYSABRI alone to treat your MS, it is not known if your chance of getting PML will be lower. Nor is it known if the length of time on treatment with TYSABRI increases your chance of getting PML. There is no known treatment, prevention, or cure for PML. If you take TYSABRI, it is important to call your doctor right away if you have any new or worsening medical problems. Tell all of your doctors that you are getting treatment with TYSABRI.
Because of the chance for PML, TYSABRI is generally recommended for patients that have not been helped enough by, or cannot tolerate other treatments for MS. TYSABRI is available only through the TOUCHTM Prescribing Program, which is a restricted distribution program. Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI. Before you take TYSABRI, you and your doctor must enroll in the TOUCH Prescribing Program and agree to the program requirements. Plan to see your doctor 3 months after the first infusion, 6 months after the first infusion, and at least as frequently as 6 months thereafter. TYSABRI does not cure MS and has not been studied longer than two years or in patients with chronic progressive MS.
You should not receive TYSABRI if you have PML or are allergic to TYSABRI or any of its ingredients.
TYSABRI is not recommended if you have a medical condition that can weaken your immune system, such as HIV infection or AIDS, leukemia or lymphoma, organ transplant, or others, or if you are taking medicines that weaken your immune system. Talk with your doctor about all of the medicines you take or have taken. TYSABRI may increase your chance of getting an unusual or serious infection. You should not take TYSABRI if you are pregnant, trying to become pregnant, or nursing.
TYSABRI may cause liver damage. Symptoms of liver damage include yellowing of the skin and eyes (jaundice), unusual darkening of the urine, nausea, feeling tired or weak, or vomiting. Blood tests can be done to check for liver damage. Call your doctor right away if you experience any symptoms of liver damage.
Other serious side effects with TYSABRI include allergic reactions (e.g., hives, itching, trouble breathing, chest pain, dizziness, chills, rash, nausea, flushing of skin, low blood pressure), including serious allergic reactions (e.g., anaphylaxis) and infections. Serious allergic reactions usually happen within 2 hours of the start of the infusion, but can happen any time after receiving TYSABRI. Tell your doctor or nurse right away if you have any symptom of an allergic reaction. You may need treatment if you are having an allergic reaction. TYSABRI may increase your chance of getting an unusual or serious infection, because it can affect your immune system.
Common side effects include headache, urinary tract infection, lung infection, pain in your arms and legs, vaginitis, stomach area pain, feeling tired, joint pain, depression, diarrhea, and rash. Tell your doctor about any side effect that bothers you or does not go away.
For full Prescribing Information, including Boxed Warning and Patient Medication Guide, go totysabri.com." title="http://www.tysabri.com." target="_blank"> www.tysabri.com.
TYSABRI is a registered trademark and TOUCHTM is a trademark of Elan Pharmaceuticals, Inc. BIOGEN IDEC and the BIOGEN IDEC logo are trademarks of Biogen Idec.
2008 Biogen Idec 01/08 3-3064-01
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The first one in the US died from it. It was unexpected and no one was looking for it. She died from it. She had a mild MS that she was determined to use the most effective treatment available. Tysabry has an effective rate of slowing it by 67%. The standard DMD's slow it by 30%.
On Autopsy the found she didn't even have MS.
The treatment for a disease she didn't have killed her.
It shook everyone up, the Docs, the FDA.
Peoplew with MS who had beniffited from it went to congress to get it returned to the market. The FDA in charge of the evaluation said the future of these people is so grim it is wrong to withold something that might prevent that future. They should be allowed to take the risk, if they know it exists.
When the first woman died, it was used with Avonnex, an interferon.
When the FDA returned it to market, it was returned as a MONOtherapy, not to be used with copaxone an returned in the US under a strict "touch" program that obly allowed it to be administered a certain infusion centers by nurses Trained to do Tysabri infusion, with a doc on the premise at the time Tysabri infusions are done. A survey of patients MS symptoms are done b/4 and each infusion to catch any signs of PLM. A plan was put in place that at signs of PLM, plasmorpheresis (blood filtering) would be done to remove the Tysabri from the body as quickly as possible.
Then after that 2 men in Europe came down with PLM. One man had previously been on Novatrone, an immunosuppressant, so he was probably 2ndary Progressive.
Europe does not have a touch program, soit was not caught early. One man ha plasmorephis right away, I read he was at home & walking. One man was in hospital, not doing well but not dead & scheduled for plasmorephis.
Nobody got PLM before their 13th infusion. More than 23,000 people are using Tysabri now, there was 1 early deaths & 2 additional PLM cases.
Unless you are describing a 4th & 5th case. But I don't thinks som I think you areosting the old news of the 2 people in Europe who came down with it. I get news alerts about MS in the morning---and it was big news when the last two were announced. I don't have any equal big news about 2 more cases. I think the 2 you are refering to, are the two gentleman in Europe a while ago.
Well have to wait and see how it goes.
Take care,
Rob
I was diagnosed with MS in 1990 and have spent many difficult years trying Betaseron then Avonex, then Rebif. The side effects from those crippled me more than my MS. The only side effects I've had from the Tysabri was being tired for the following 24 hours. And after today's infusion I didn't even feel that.
The two cases of PML which ocurred last July in Europe did not have the advantage of the Touch program where they monitor you so closely. Those cases used the plasma therapy to remove the Tysabri and one patient went home without problems and the second needed further treatment, but neither died. The only death was from the one person who was taking it with Avonex several years ago.
It is a very personal decision and it took me a while before I had done enough research on it to feel comfortable going oit. But I can say now I'm very glad I did.