Re: Re: Glad I am not in that small 0.1%

[Guest guest]

Fran - thank you much for that superbelchfire explanation which explains

everything - including my reaction to xolair 20 hrs after my first injections.

My mother was frightened by a mouse while she was carrying me, a massive burden

unto itself, and I, as a result, on a postpartum basis, never liked the little

blighters either - nor does my spouse, Gwynne, or our dog, April, who would

probably kill and eat the little bugger. I highly doubt, however, if Gwynne

would eat one - more likely she'd call Terminex, as she has in the past, to try

to get rid of me and the mouse on a group rate basis.

I apologize for the above aberrant discourse, but it is well into fruit of the

vine hours, and my cup ranneth over, allowing Satan to make me do it.

Terry a.k.a. Ohldepharte

----- Original Message -----

From: tiredofsteroids

Sent: Saturday, March 10, 2007 4:50 PM

Subject: [ ] Re: Glad I am not in that small 0.1%

Xolair is what is called a humanized monoclonal antibody. This kind

of antibody is created in the lab by attaching a piece of a mouse

antibody to a backbone of a human antibody. In the case of Xolair,

the piece of mouse antibody comes from whole mouse anti-IgE, that is

antibody developed against IgE, specifically against the portion of

the IgE molecule that attaches to mast cells to trigger allergic

reactions. The portion of the anti-IgE antibody that binds to the

mast cells is the piece of mouse antibody that is then attached to a

backbone of human antibody. So Xolair is a mouse-human chimera.

Antibodies are very large proteins and any protein can act as an

allergen (as can a number of other types of molecules, even

steroids). Since Xolair is partly mouse protein, a foreign substance,

it's easy and reasonable to theorize that it can be an allergic

trigger.

The application Genentech made to the FDA for approval of Xolair

(http://www.fda.gov/cder/biologics/review/omalgen062003r1.pdf)

documents 3 anaphylactic reactions that were assessed by the

investigators to be related to Xolair. In each case, the anaphylactic

reaction occurred 1.5-2 hours after the injection. Other allergic

reactions, inlcuding hives and other rashes, itching, facial

flushing, and facial swelling, were also documented and assessed to

be related to Xolair. You can read about these cases starting on page

84 of the study at the website I gave above.

I hope you find this information to be illuminating and interesting!

Even though the percentages of anaphylactic reactions (0.1%) and

other adverse reactions prompting discontinuation of Xolair(2%)are

small, it behooves us all to recognize that there is no way of

predicting who will or will not react in an adverse way and we should

protect ourselves by erring on the side of caution in terms of

waiting after receiving an injection.

This is no different than for allergy shots themselves, which can

cause serious 1st and subsequent reactions even after years of

uneventful injections for a given patient. And, as I've mentioned in

a previous post, deciding to start or continue Xolair treatment is

like anything else - you and your doctor need to weigh risks vs.

benefits for your individual situation before making the decision.

Fran

I

> have been on Xolair since September 2003. Two shots every two weeks.

> > After all those shots, not ONE reaction. Nada, Zip an Zilch! I

> can't

> > even tell where the injection was given 5 minutes later.

> >

> > I cant count how many of my regular allergy shots hurt swolen up

> > around the injection site. Xolair never has.

> >

> > I sure am glad I am not in that very small 0.1%

> >

> > Doug

> > Group Founder

> >

> >

> >

> >

> >

> >

> > ---------------------------------

> > Now that's room service! Choose from over 150,000 hotels

> > in 45,000 destinations on Travel to find your fit.

> >

> >

[Guest guest]

Addy

Group co-owner

pleased to announce that spring has come to North Carolina and my

sinuses are protesting. Or maybe they're protesting the fact that

the Duke men's AND women's basketball teams both lost to State in the

first round of the ACC tournament. (Not that it isn't State's turn,

b/c they are long overdue, God bless 'em) Insert your own soapbox

statement here.

As a loyal Duke alumnus, I can only predict that those are

the last two games NC State will win this season. Boy howdy,

spring is here i NC, along with the seventies. Hallelujah!!

On a connected note, is there any explanation why xolair is so

bloody expensive? I mean, mice are cheap - free, in fact, in my

attic during the winter.

Terry

----- Original Message -----

From: pyle456

Sent: Saturday, March 10, 2007 5:11 AM

Subject: [ ] Re: Glad I am not in that small 0.1%

I, too, would like more info about the .1%. not that I'm worried,

but I want to know things like

1) how many of those people ever had an anaphylactic reaction prior

to Xolair.

2) did they have exposure to anything else that might have triggered

the reported reaction?

3) what is the percentage of patients and doctors reporting

reactions to Xolair vs the average percentage of reports on other

drugs (for instance, are Xolair docs and patients reporting things

that they might not otherwise report since Xolair is so special)

4) like you, I want to know what is the mechanism for the

anaphylactic reaction.

5) do these folks have an associated or additional condition that

might make them more prone to have an anaphylactic reaction that

would indicate that that condition in combination with Xolair creates

a slightly higher risk?

Addy

Group co-owner

pleased to announce that spring has come to North Carolina and my

sinuses are protesting. Or maybe they're protesting the fact that

the Duke men's AND women's basketball teams both lost to State in the

first round of the ACC tournament. (Not that it isn't State's turn,

b/c they are long overdue, God bless 'em) Insert your own soapbox

statement here.

I

> have been on Xolair since September 2003. Two shots every two weeks.

> > After all those shots, not ONE reaction. Nada, Zip an Zilch! I

> can't

> > even tell where the injection was given 5 minutes later.

> >

> > I cant count how many of my regular allergy shots hurt swolen up

> > around the injection site. Xolair never has.

> >

> > I sure am glad I am not in that very small 0.1%

> >

> > Doug

> > Group Founder

> >

> >

> >

> >

> >

> >

> > ---------------------------------

> > Now that's room service! Choose from over 150,000 hotels

> > in 45,000 destinations on Travel to find your fit.

> >

> >

[Guest guest]

Those are all my questions exactly. I think I've mentioned before, the doctor

who is monitoring my xolair shots has a research clinic and one of the ongoing

studies is on xolair (Isn't that right JoAnn?--She works for my doctor and is

the one who gives me my shots.) I am not part of any research, but I always

tell them how I have fared after each shot. I think when I asked the last time,

if I recall correctly, not one of their patients has had an anaphylactic

reaction.

So====Addy, thanks for posing those questions. When my husband and I were

talking about this, I posed these exact same questions to him, in reassuring him

that as far as I could determine, this would not pose a problem for me since I

have never ever had an anaph. reaction to anything. But then I have already

taken my allegra, nebbed, and used my AdVair and my spiriva before I go get my

shots.

I am also wondering if maybe the reporting is a little skewed with the docs

reporting on those bad reactions and not reporting the number of shots given

with NO reaction or very little reaction. Just wondering.........

Adah

pyle456 <coachmac@...> wrote:

I, too, would like more info about the .1%. not that I'm worried,

but I want to know things like

1) how many of those people ever had an anaphylactic reaction prior

to Xolair.

2) did they have exposure to anything else that might have triggered

the reported reaction?

3) what is the percentage of patients and doctors reporting

reactions to Xolair vs the average percentage of reports on other

drugs (for instance, are Xolair docs and patients reporting things

that they might not otherwise report since Xolair is so special)

4) like you, I want to know what is the mechanism for the

anaphylactic reaction.

5) do these folks have an associated or additional condition that

might make them more prone to have an anaphylactic reaction that

would indicate that that condition in combination with Xolair creates

a slightly higher risk?

Addy

Group co-owner

pleased to announce that spring has come to North Carolina and my

sinuses are protesting. Or maybe they're protesting the fact that

the Duke men's AND women's basketball teams both lost to State in the

first round of the ACC tournament. (Not that it isn't State's turn,

b/c they are long overdue, God bless 'em) Insert your own soapbox

statement here.

I

> have been on Xolair since September 2003. Two shots every two weeks.

> > After all those shots, not ONE reaction. Nada, Zip an Zilch! I

> can't

> > even tell where the injection was given 5 minutes later.

> >

> > I cant count how many of my regular allergy shots hurt swolen up

> > around the injection site. Xolair never has.

> >

> > I sure am glad I am not in that very small 0.1%

> >

> > Doug

> > Group Founder

> >

> >

> >

> >

> >

> >

> > ---------------------------------

> > Now that's room service! Choose from over 150,000 hotels

> > in 45,000 destinations on Travel to find your fit.

> >

> >

[Guest guest]

terry - your bit about free mice made me laugh!

from what i read early in my xolair process, the xolair is actually made up of

something in chinese hampster ovaries. what i wanna know is who in their right

mind decided to grind up chinese hampster ovaries, inject them into themselves

for months and months and then realize, " hey, my asthma and allergies are

improving " . i'm glad for those scientists, because i know i'd never go to a pet

store looking for something to help my asthma - LOL

as far as the price and its insanity, my thoughts, in addition to addy's are

that i'm guessing we're still paying for the research that went in to develop

xolair....and quite honestly, if we're willing to pay that much money for

something, why would they lower the price. its the ol' supply and demand thing.

heather

pyle456 <coachmac@...> wrote:

( I think) says that the antibodies are actually chinese

hamster. So I'm guessing that in addition to paying for all those

wonderful clinical trials, we are paying some sort of tarriff

(spelling) for importing the hamsters from china. I wonder if

they're required to prove that they can't find work in their own

country or if their required to prove that good old North American

hamsters won't provide the required antibodies for a particular

reason.

No, Terry, State's gotta beat Carolina tomorrow. You know the rules.

Addy

I

> > have been on Xolair since September 2003. Two shots every two

weeks.

> > > After all those shots, not ONE reaction. Nada, Zip an Zilch!

I

> > can't

> > > even tell where the injection was given 5 minutes later.

> > >

> > > I cant count how many of my regular allergy shots hurt swolen

up

> > > around the injection site. Xolair never has.

> > >

> > > I sure am glad I am not in that very small 0.1%

> > >

> > > Doug

> > > Group Founder

> > >

> > >

> > >

> > >

> > >

> > >

> > > ---------------------------------

> > > Now that's room service! Choose from over 150,000 hotels

> > > in 45,000 destinations on Travel to find your fit.

> > >

> > >