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Re: Re: Maximum Dose

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Actually if you go to the FDA website there is a chart that tells you what the

max dose per height/weight that has been approved. I'm thinking that it's

something like schedule15 or 16. There are A LOT of pages to go through to

find that. I did post that info on here about a month ago....I THINK!! Check

the group archives, if you can't find it there I can repost my old email...if i

haven't trashed it.

Kathe

----- Original Message ----

From: uca79iii <bme1979@...>

Sent: Friday, October 26, 2007 10:41:39 AM

Subject: [ ] Re: Maximum Dose

--- In , " marieruffolo " <marieruffolo@ ...>

wrote:

>

> First of all, what was I thinking? In my letter to Laurie, I

> wrote " bearly " instead of " barely " . As an obessive compulsive, (and p/t

> writer), this bothered me until I straightened it out. OK. Now. I have

> a question for Doug:

>

> What is the highest dose of Xolair that has thus far been

> administered/ approved? Thanks-

>

> Marie

>

Marie,

I am flattered that you would ask my opinion but I am just a patient

like yourself. I have no clue. My college degree was in music

education and masters in religious education not medicine LOL! (wink)

This is a question only your doctor or one of our xolair professionals

who is on this board can answer.

Happy breathing :))

Doug :))

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That's what we're all here for!!! I did do a bit of extra snooping on

the FDA site. I found out a few more interesting things that I think we sould

all know about.

ENJOY!!!!

Kathe

1. Three cases of anaphylaxis were identified among the 3,507 subjects exposed

to Xolair in premarketing clinical trials. Reports of anaphylaxis were based on

investigator judgment in relationship to the study drug. The time to onset of

anaphylaxis after administration of Xolair in these three patients was: 90

minutes in two patients 2 hours in one patient. You can find that here!!

http://www.fda.gov/cder/drug/InfoSheets/HCP/omalizumabHCP.htm

2. Here it says in the trials the max dose was 750mg every 4 weeks.

ttp://www.fda.gov/cder/foi/label/2007/103976s5102lbl.pdf Xolair dosing was

based on body weight and baseline serum total IgE concentration. All patients

were required to have a baseline IgE between 30 and 700 IU/mL and body weight

not more than 150 kg. 150kg=330.693 lbs. ( I personally give myself 300mg

every two weeks. Yes...you read that correctly!! I self inject and I AM NOT in

the medical field!)

3. AND THEN there is the " overdose section " ......

OVERDOSAGE The maximum tolerated dose of Xolair has not been determined. Single

intravenous doses of up to 4000 mg have been administered to patients without

evidence of dose-limiting toxicities. The highest cumulative dose administered

to patients was 44,000 mg over a 20-week period, which was NOT associated with

toxicities.

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