My Tysabri Diary...

A very happy belated Fourth of July wish for all of you, I hope your holiday was safe and filled with good food (heehee). I made my famous barbecued chicken wings recipe, no-mayonnaise potato salad (the potatoes are parboiled and then grilled for a smoky flavor, mixed with grilled onions, bacon, blue cheese dressing and balsamic vinegar), and then I made my delicious carrot & raisin salad...., oh my goodness, everyone stuffed their faces...soooooooo yummy!

As I watched the spectacular fireworks display out here, I couldn't help but remember my MS friends who were never able to see the fireworks on Friday the 4th because they had lost their vision (or a majority of their vision) due to their MS. Because of this, I wanted to post the following link on my blog which is a short 3 1/2 minute video that explains How Tysabri Works. I thought it was fitting considering that not only does Tysabri prevent worsening of vision loss in patients with relapsing MS, Tysabri is also associated with significant reductions in the likelihood of sustained vision loss.

How Tysabri Works:

http://tinyurl.com/How-Tysabri-Works

So, on to better subjects...here is my 23rd Tysabri infusion report: I had my 23rd Tysabri infusion on Wednesday, 7/9... all went well, no problems, no surprises, and no terrible multiple "sticks"... one stick and my regular infusion nurse had a line in. I asked my infusion nurse how the other Tysabri patients in our small infusion center were doing, and she said they are all doing very well. So I really have nothing new to report.

In the interim, someone asked me a question regarding a friend of theirs that was recently diagnosed with MS, and their neurologist placed him on Avonex, which his friend really didn't want to go on, so he asked me this question: "Can my friend go directly onto Tysabri as a first line therapy? Or does he have to fail on a CRAB first? I just don't know what the TOUCH protocol is"..., my answer is yes, he can go directly onto Tysabri as a first-line therapy IF his neurologist recommends it (which obviously, his neurologist doesn't); there is also the issue of whether or not the patient's insurance would question Tysabri as first-line therapy, and the neurologist really has to convince the insurance company that 1) the patient cannot tolerate the other therapies [the patient is needle phobic], or 2) the patient has a highly aggressive form of MS and the neurologist does not want to wait and try the other ABCRs first.

The FDA clarified their response to Tysabri's use as a first-line and/or second-line therapy for MS...see:

http://tinyurl.com/FDA-Memorandum

Clarification article by the FDA regarding Tysabri's use as a first-line AND/OR second-line therapy for MS patients

First-line Tysabri therapy in some MS patients

MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH

SUBJECT: Errata to FDA Background document for the Tysabri (natalizumab) Advisory Committee on July 31, 2007 In the reviews, Tab 1 (FDA Clinical Review) and Tab 2 (Office of Surveillance and Epidemiology Review), it was stated that the MS population to receive Tysabri should be those “unable to tolerate or with an inadequate response to other available MS therapies” and it was stated that the indication was revised to “relegate it [Tysabri] to a second-line therapy for relapsing-remitting MS.” The indication in the current label states “…Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies.”

FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommended for patients who have had an inadequate response to, or are unable totolerate [i.e., needle phobic patients] alternative multiple sclerosis therapies (e.g., as second-line therapy).

However, the indication statement does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.

So as you can see, it really depends on the neurologists' recommendation. If the newly diagnosed MS patient feels that a second opinion is in order (I mean really, Avonex is a once a week shot into the muscle and is only 32% effective at preventing further relapses/slowing the disease process down with horrible flulike side effects, whereas Tysabri is 67% effective with only minimal to no side effects for most of the MS patients, has proven data showing an 83% reduction in the accumulation of new or enlarging lesions over two years, as well as 92% fewer lesions during Tysabri therapy after both one and two years)..., he should contact MSActiveSource at 1-800-456-2255 and request three names and numbers of Touch certified neurologists near him so that he can make an appointment with one of them...he only needs to provide his ZIP code to them.

I hope that this information was of some help to that new MS patient. I also told him that if he decides to go with Avonex first, I suggested that he take a liquid Advil approximately 20 minutes before the shot, and ice the injection site (place an ice cube wrapped in a washcloth) for approximately 5 minutes before the injection as this will help with the pain of the needle going into the muscle...and I also suggested that he do his shot just before he goes to bed (hopefully he can sleep through the majority of its flulike side effects) and has the next couple of days to recuperate from its side effects. And I also reminded him that I was not a doctor, the above is only my opinion, with the exception of the proven Tysabri data that I mentioned (proven data is not my opinion, it is fact).

I was pretty tired Wednesday after my infusion so I ate a small dinner of pizza & pasta, accompanied by a mudslide or two, and then turned in.

I have a ton of new e-mails that I need to answer, and I hope to respond to some of your comments left recently on my blog... until then, have a wonderful weekend everyone.

((((hugs))))

Love, Lauren :)