Tysabri

msladyinca · Sep 20, 2007

hi wyorn3,

i have had 13 infusions of tysabri since october, 2006, and have had zero side effects and zero adverse reactions (including zero infusion adverse reactions) from tysabri.

you ask:

has anyone given tysabri. its iv and used as a last resort in ms cases. this is a new drug in our facility and a representative is flying in to discuss the drug with us. just wondering if anyone has had issues with it or not. thanks so much. wyorn3

it is given by infusion every 28 days and it most certainly is not used as a last resort in ms cases...tysabri is a first line and/or a second line therapy for ms. the tysabri label states: "tysabri® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."

furthermore, please see the 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

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, 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.

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-02-fda-errata.pdf

this was specifically done to clarify tysabri's use as many ms patients are needle phobic (which makes the abcrs intolerable for the patient, including their side effects and injection site reactions) and/or the patient has an aggressive form of ms, and their doctors do not wish for that patient to have to endure further relapses should they be relegated to be on any of the abcrs first.

tysabri's use as a first-line and/or second-line therapy for ms is to be decided by the patient's treating physician, and no one else.

you may wish to discuss be above with the representative that is flying in today to discuss tysabri with each of you at your infusion center.

i wish you all well, and only the very best that life can bring.

lauren (ms patient for 31 plus years & very happy tysabri patient)

herecomestrouble · Sep 21, 2007

That was very interesting,thank you

gitammy · Sep 21, 2007

Tysabri is an interesting medication. We have given the infusions for quite some time. The rep should give you plenty of information about the drug and infusion requirements. It is typically infused over an hour, and we do vitals every 30 minutes We observe the patient 1 hour post infusion (letting 100 mL NS infuse during observation time). PML is major concern with this drug.

leslie :-D · Sep 21, 2007

this medication is indeed promising.

http://www.en.wikipedia.org/wiki/Natalizumab

leslie

WyoRN3 · Sep 21, 2007

Thanks so much for your response. The rep just left and i was very glad to have your info first so that I could ask questions. I totally thought it was a last ditch drug for MS and now realize what an awesome drug this is turning out to be for these patients. We are a very small hospital and have only one patient currently scheduled to receive this drug, but I really hope word gets around to our docs about how promising this can be. Again Thank you WyoRN3