I can answer - No more shots at home

[Guest guest]

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

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