Re: I can answer - No more shots at home

[Guest guest]

THANK YOU, PAT, FOR SHARING THIS INCREDIBLY IMPORTANT, SENSIBLE (in

more ways than one) and TIMELY INFORMATION. You and Fran have

explained a lot to us in the last week or so. I will try to compile

all this into a file so that we can refer future " newbies " to it!

Addy

Group co-owner

>

> Hello all. I was just at a taining weekend for speakers to learn

to teach nurses and physicians about Xolair. The answer to no more

shots at home is lengthy, so bear with me.

>

> First: Xolair is a protein. This protein binds the receptor

site on the IGE where allergens attach, so the allergens can't

attach. We are exposed to our allergens continually unless you have

moved our been able to get rid of the source of your allergen, so we

continue to make IGE. The Xolair binds the free floating IGE that

our bodies keep producing. Since Xolair is a protein, the protein

molecule must stay as it is and not get broken, to function in the

capacity it is meant to function. If the protein molecule gets

broken, the body sees the Xolair protein as a foreign substance and

starts an immediate reaction, sometimes something close to

anaphylaxis called an anaphylactoid reaction. Hives can occur,

shortness of breath, facial or tongue swelling and blood pressure

drop. 42 cases of this " type " of reaction were reported from 2003 to

2005 (2.5 years). 21 cases have been deemed to be " possible "

anaphylactoid reactions. The proper testing of these individuals

> weren't done by the offices where they got their injections so it

is impossible to tell if the reactions were true

anaphylaxis/anaphylactoid reactions or simply the bodies reaction to

broken Xolair protein. We were told one of the 3 that was reported

during clinical trials was not an anaphylaxis reacton but a reaction

to peanuts. It takes a varied amount of time to bind all of the free

floating IGE in your system. It is truly individual because of

disease state and IGE level. Some people it takes 1 year to work and

some people feel better after a few shots. Most of the 21 people who

could have had this anaphylactoid reaction were after their 3rd shot

making it highly unlikely that this type of reaction would occur.

BUT the FDA has issued a strong statement that Xolair be administered

in the physician's office due to the recent data. When mixing Xolair

the diluent has to be squirted slowly into the vial, the vial then

needs to be swirled gently, the Xolair then needs

> to be left for about 20 minutes so the proteins can distribute

completely through the diluent. If agitated, shaken, forcelfully

swirled, or the diluent is forcefully dquirted into the vial, you

could have one of these anaphylactoid reactions. If this reaction is

a true reaction, you have to have an Epi-Pen administered, have your

blood pressure taken every 15 minutes, be watched for low blood

oxygen level, and the office needs to draw blood for testing to make

sure it was a true anaphylaxis/anaphylactoid reaction. This is why

the FDA is worried about home injection. A nurse can make a mistake

in mixing, but should be FAR less likeliy to make such a mistake.

The treatment required after such a reaction has to be immediate.

So, again, the physicians office is the best place.

>

> OK, now that we are through that. Some of the physicians I spoke

to are still letting their patients who have never had an

anaphlyaxis/anaphlyactoid reaction to anything in the past give self

injections at home after the first 6 doses are administered. An Epi-

pen is given to the patient and strict rules to follow. You have to

realize that you could possibly do harm to yourself if you are in a

rush and can't devote the time to mix properly and wait the 20

minutes before injecting. If you casue large bubbles in the mixture,

you have broken down the protein and should throw that vial away. (a

few very small ones are natural) These physicians I spoke with have

a form for the patients to sign that spells out exactly how to dilute

the Xolair, that the patient acknowledges it, the patient has an epi-

pen, and has a contingency plan of care to call 911 if they have to

use the epi-pen and get to the hospital. The reactions constitute

20% less than 1% of the peolpe on Xolair.

>

>

> The physicians recognize this is a very small percentage of

people who react to Xolair. Compared to patients who have to take

remicade oe penicillin for instance, the reaction is 5-15%. No

decimal point on that, so 5 to 15 people out of 100 will react to the

drug remicade or penicillin. The reaction rate is 0.05% for Xolair.

1/20th of 1 person out of 100 will react to Xolair. Very small

number and may not be a true reaction, it may be the way the Xolair

was mixed. Interestingly some people who had such a reaction tried

the Xolair again with no problem. I can't remember how many,

something like 17 out of the original 42, but out of the 21 that were

deemed " possible " reactions, I can't remember that number.

>

> So, it is being pushed by the FDA not your physicians. The

physicians are just trying to cover their behinds in case something

does happen so they won't get sued. My suggestion to you is to ask

for a contract to sign and a prescription for an epi-pen. You should

already have the epi-pen, but make sure they teach you how to use

it. Be comfortable with it. Never be in a rush to mix your Xolair.

Inject it slowly over 30 seconds, use a clock with a second hand and

slowly administer it. Administerring it too fast will also break the

protein molecules by the force it is squeezed through the needle.

>

> So, good luck all you home injectors. To the rest of us, this is

why they keep you 2 hours. During the clinical trials they watched

patients for 2 hours. Allergy shots are watched for 30 minutes. You

can also ask your physician if you can sign a form to leave the

office after 30 minutes like an allergy injection (after you have had

your 6th dose). Have a prescription for an epi-pen, carry it with

you to and from the doctor office, know where the local hospitals and

emergency clinics are for your doctors peace of mind as well as your

own peace of mind. This new information in my opnion shouldn't

change how they practice and some physicians are not changing, but

they also don't wan to be sued. So, speak to your physician. Please

don't ever be afraid to ask questions. Write them down so you don't

forget. The physicians I talked to this weekend say they have about

8 minutes per person. We can be pro-active, have our questions

written down. When he or she asks " So,

> how are you? " PLEASE do not respond " fine " unless you really

are. If you notice anything please tell them. This goes for all of

our physicians, not just our pulmonologist/allergist. 80% of

Asthmatics are being taken care of by general or family

practitioners, this is outrageous to me. Only 20% of us asthamatics

are taken care of by an allergist/pulmonologist. Encourage your

friends, acquaintances, family to seek specialists atleast in this

area. If you had a heart problem, you would see a cardiologist,

right? Help them be proactive for themselves and their families.

>

> Xolair is an awesome drug that I have personally seen get people

off many of their medications, oxygen etc... and given them back

their lives. I personally know people who were confined to home and

are now able to go to work, go fishing, tend their garden, go for a

hike in the woods when all of these things were forbidden when their

allergies & asthma weren't in control. Keep in mind everyone is

different, it takes longer for some to see a difference. Ask your

family & friends, I bet they can tell you don't choke on phlegm at

nite, don't sneeze or cough as much at work, don't complain about

walking the mall anymore etc... Get informed, stay informed & be

proactive for yourself and everyone you know. OH, remember that your

insurance company may cover Xolair differently than someone elses

ins. So, know if you Xolair is covered under a pharmacy benefit or

medical benefit ad how much your copays are if you home injection vs

physician office. This may be a determining

> factor for you.

>

> Hope this helped.

> Pat

>

>

>

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

> Expecting? Get great news right away with email Auto-Check.

> Try the Beta.

>

>

[Guest guest]

pat,

thank you for taking the time to explain it all to us. i had no idea that the

mixing process was so important...that the addition of teh saline or mixing it

too quickly could ruin it!!! i was trained way back when by a xolair nurse how

to mix it and inject it. i don't recall her stressing how important the process

was (outside of " well, add water b/c you can't inject it as a powder!). i'm

printing out your email and i'll bring it with me to the dr, just so they can

read it.

thanks again for explaining it to us. we're lucky to have you!!

heather

MommaA <mommaa@...> wrote:

Hello all. I was just at a taining weekend for speakers to learn to teach

nurses and physicians about Xolair. The answer to no more shots at home is

lengthy, so bear with me.

First: Xolair is a protein. This protein binds the receptor site on the IGE

where allergens attach, so the allergens can't attach. We are exposed to our

allergens continually unless you have moved our been able to get rid of the

source of your allergen, so we continue to make IGE. The Xolair binds the free

floating IGE that our bodies keep producing. Since Xolair is a protein, the

protein molecule must stay as it is and not get broken, to function in the

capacity it is meant to function. If the protein molecule gets broken, the body

sees the Xolair protein as a foreign substance and starts an immediate reaction,

sometimes something close to anaphylaxis called an anaphylactoid reaction. Hives

can occur, shortness of breath, facial or tongue swelling and blood pressure

drop. 42 cases of this " type " of reaction were reported from 2003 to 2005 (2.5

years). 21 cases have been deemed to be " possible " anaphylactoid reactions. The

proper testing of these individuals

weren't done by the offices where they got their injections so it is impossible

to tell if the reactions were true anaphylaxis/anaphylactoid reactions or simply

the bodies reaction to broken Xolair protein. We were told one of the 3 that was

reported during clinical trials was not an anaphylaxis reacton but a reaction to

peanuts. It takes a varied amount of time to bind all of the free floating IGE

in your system. It is truly individual because of disease state and IGE level.

Some people it takes 1 year to work and some people feel better after a few

shots. Most of the 21 people who could have had this anaphylactoid reaction were

after their 3rd shot making it highly unlikely that this type of reaction would

occur. BUT the FDA has issued a strong statement that Xolair be administered in

the physician's office due to the recent data. When mixing Xolair the diluent

has to be squirted slowly into the vial, the vial then needs to be swirled

gently, the Xolair then needs

to be left for about 20 minutes so the proteins can distribute completely

through the diluent. If agitated, shaken, forcelfully swirled, or the diluent is

forcefully dquirted into the vial, you could have one of these anaphylactoid

reactions. If this reaction is a true reaction, you have to have an Epi-Pen

administered, have your blood pressure taken every 15 minutes, be watched for

low blood oxygen level, and the office needs to draw blood for testing to make

sure it was a true anaphylaxis/anaphylactoid reaction. This is why the FDA is

worried about home injection. A nurse can make a mistake in mixing, but should

be FAR less likeliy to make such a mistake. The treatment required after such a

reaction has to be immediate. So, again, the physicians office is the best

place.

OK, now that we are through that. Some of the physicians I spoke to are still

letting their patients who have never had an anaphlyaxis/anaphlyactoid reaction

to anything in the past give self injections at home after the first 6 doses are

administered. An Epi-pen is given to the patient and strict rules to follow. You

have to realize that you could possibly do harm to yourself if you are in a rush

and can't devote the time to mix properly and wait the 20 minutes before

injecting. If you casue large bubbles in the mixture, you have broken down the

protein and should throw that vial away. (a few very small ones are natural)

These physicians I spoke with have a form for the patients to sign that spells

out exactly how to dilute the Xolair, that the patient acknowledges it, the

patient has an epi-pen, and has a contingency plan of care to call 911 if they

have to use the epi-pen and get to the hospital. The reactions constitute 20%

less than 1% of the peolpe on Xolair.

The physicians recognize this is a very small percentage of people who react to

Xolair. Compared to patients who have to take remicade oe penicillin for

instance, the reaction is 5-15%. No decimal point on that, so 5 to 15 people out

of 100 will react to the drug remicade or penicillin. The reaction rate is 0.05%

for Xolair. 1/20th of 1 person out of 100 will react to Xolair. Very small

number and may not be a true reaction, it may be the way the Xolair was mixed.

Interestingly some people who had such a reaction tried the Xolair again with no

problem. I can't remember how many, something like 17 out of the original 42,

but out of the 21 that were deemed " possible " reactions, I can't remember that

number.

So, it is being pushed by the FDA not your physicians. The physicians are just

trying to cover their behinds in case something does happen so they won't get

sued. My suggestion to you is to ask for a contract to sign and a prescription

for an epi-pen. You should already have the epi-pen, but make sure they teach

you how to use it. Be comfortable with it. Never be in a rush to mix your

Xolair. Inject it slowly over 30 seconds, use a clock with a second hand and

slowly administer it. Administerring it too fast will also break the protein

molecules by the force it is squeezed through the needle.

So, good luck all you home injectors. To the rest of us, this is why they keep

you 2 hours. During the clinical trials they watched patients for 2 hours.

Allergy shots are watched for 30 minutes. You can also ask your physician if you

can sign a form to leave the office after 30 minutes like an allergy injection

(after you have had your 6th dose). Have a prescription for an epi-pen, carry it

with you to and from the doctor office, know where the local hospitals and

emergency clinics are for your doctors peace of mind as well as your own peace

of mind. This new information in my opnion shouldn't change how they practice

and some physicians are not changing, but they also don't wan to be sued. So,

speak to your physician. Please don't ever be afraid to ask questions. Write

them down so you don't forget. The physicians I talked to this weekend say they

have about 8 minutes per person. We can be pro-active, have our questions

written down. When he or she asks " So,

how are you? " PLEASE do not respond " fine " unless you really are. If you notice

anything please tell them. This goes for all of our physicians, not just our

pulmonologist/allergist. 80% of Asthmatics are being taken care of by general or

family practitioners, this is outrageous to me. Only 20% of us asthamatics are

taken care of by an allergist/pulmonologist. Encourage your friends,

acquaintances, family to seek specialists atleast in this area. If you had a

heart problem, you would see a cardiologist, right? Help them be proactive for

themselves and their families.

Xolair is an awesome drug that I have personally seen get people off many of

their medications, oxygen etc... and given them back their lives. I personally

know people who were confined to home and are now able to go to work, go

fishing, tend their garden, go for a hike in the woods when all of these things

were forbidden when their allergies & asthma weren't in control. Keep in mind

everyone is different, it takes longer for some to see a difference. Ask your

family & friends, I bet they can tell you don't choke on phlegm at nite, don't

sneeze or cough as much at work, don't complain about walking the mall anymore

etc... Get informed, stay informed & be proactive for yourself and everyone you

know. OH, remember that your insurance company may cover Xolair differently than

someone elses ins. So, know if you Xolair is covered under a pharmacy benefit or

medical benefit ad how much your copays are if you home injection vs physician

office. This may be a determining

factor for you.

Hope this helped.

Pat

---------------------------------

Expecting? Get great news right away with email Auto-Check.

Try the Beta.