Re: Xolair at age 5?

October 12, 2010

Genentech was in the midst of approving xolair for ages 6-12. it was halted due

to concerns about anaphylaxis and malignancy. there are no trials below age of 6

at this time.

You will have a very difficult time getting xolair approved for your child, who

is below 6 years of age. when there is no literature to support this kind of

therapeutic decision, payment will be virtually impossible. a young child's

immune system is still in a very dynamic and developmental stage, and your

pediatric allergist would likely be reluctant to attempt to use in such a young

age. below is an excerpt from xolair's prescribing information.

8.4 Pediatric Use

Safety and effectiveness of Xolair were evaluated in 2 studies in 926 (Xolair

624; placebo 302) asthma patients 6 to <12 years of age. One study was a pivotal

study of similar design and conduct to that of adult and adolescent studies 1

and 2 [see Clinical Trials (14)]. The other study was primarily a safety study

and included evaluation of efficacy as a secondary outcome. In the pivotal

study, Xolair-treated patients had a statistically significant reduction in the

rate of exacerbations (exacerbation was defined as worsening of asthma that

required treatment with systemic corticosteroids or a doubling of the baseline

ICS dose), but other efficacy variables such as nocturnal symptom scores,

beta-agonist use, and measures of airflow (FEV1) were not significantly

different in Xolair-treated patients compared to placebo. Considering the risk

of anaphylaxis and malignancy seen in Xolair-treated patients >12 years old and

the modest efficacy of Xolair in the pivotal pediatric study, the risk-benefit

assessment does not support the use of Xolair in patients 6 to <12 years of age.

Although patients treated with Xolair in these two studies did not develop

anaphylaxis or malignancy, the studies are not adequate to address these

concerns because patients with a history of anaphylaxis or malignancy were

excluded, and the duration of exposure and sample size were not large enough to

exclude these risks in patients 6 to <12 years of age. Furthermore, there is no

reason to expect that younger pediatric patients would not be at risk of

anaphylaxis and malignancy seen in adult and adolescent patients with Xolair.

[see Warnings and Precautions (5.1) (5.2); and Adverse Reactions (6)].

________________________________

From: Kendra Tiedemann <kendra.tiedemann@...>

Sent: Mon, October 11, 2010 7:41:49 PM

Subject: [ ] Xolair at age 5?

Hello, everyone!

I am the mother of a 5 year old with moderate persistent asthma and severe

eczema which are closely tied to his food, pet and environmental allergies.

He also has eosinophilic esophagitis (EoE). With the effects of each

condition considered, ie is effectively allergic to every food that he

has ever eaten with only one exception: cane sugar. His diet has, since

August 2008, been limited to Neocate One Plus, Neocate Nutra, artificial

colors and artificial flavors with cane sugar added back to his diet in

December 2008. Attempts to reintroduce other foods have consistently

failed. Occasionally, ie will outgrow a food allergy but then will

quickly resensitize after eating it again for a matter of weeks. Perhaps

most problematic is the airborne aspect of certain food allergies. Peeling

oranges in his presence causes immediate bronchospasm, as does the use of

orange-based cleaners. Cooking or reheating of eggs and pork cause

wheezing, coughing and a flare of his eczema even if they are only minor

ingredients. Peanuts and tree nuts will cause a rash and bronchospasm even

without heating. This effectively prevents him from even walking into a

grocery store from mid-November through the end of the year when bulk bins

of nuts are unavoidable. After a recent increase in the frequency of

airborne food reactions, ie now becomes quite anxious whenever he smells

food and cleansers anywhere away from home. Contact reactions are also

problematic, but easier to deal with. Allergy shots were initiated in June

2008 when outside time had to be limited to a cumulative 30 minutes per day.

ie can now play outside for up to an hour at a time before the wheezing

and coughing begin -- 90 minutes outside last week led to a flare of asthma

and allergic rhinitis that we are still fighting.

Medications that are currently in use are Pulmicort (nebbed once daily in

the summer, twice daily otherwise), albuterol (nebbed at varying rates),

Singulair (daily), Allegra (twice daily), Periactin (two to three times

daily), Nasonex (once to twice daily), Benadryl (mostly for breakthrough

hives and reactions at school), EpiPen Jr (used once, narrowly avoided too

many times to count) and Orapred (roughly 5 to 7 days per month except in

summer). Today was Day 4 of Orapred. ie's lungs are essentially clear

of wheeze and crackle, but the bronchospasms continue. Daytime is bearable,

but last night we were still doing neb treatments every 2 1/2 hours with

plenty of coughing in between. I was up all night repositioning him because

he couldn't catch a breath between coughs unless he was propped upright.

Albuterol in his neb did help, but not completely and never for long. We

added a nasal steroid today with the hope that doing so will allow us to

avoid extending the Orapred beyond 5 days. I am not holding my breath...

Historically, we have not pursued Xolair due to ie's age and because his

quality of life was still pretty good. That is no longer the case. Now in

kindergarten, he is noticing all that he misses out on due to airborne

environmental and food allergens. The anxiety is new and very concerning,

as he has always had a lot of self-confidence. Until very recently, ie

was respectful of his allergens but not afraid of them. Now that he is in

school full time, his education is being negatively impacted. He missed 6

of the first 40 days of school and has had multiple early dismissals for

medical appointments that could only be scheduled during the school day.

Just as we get him caught up from one absence, he is out again. As of now,

we have his pediatrician, a GI specialist and 2 allergists recommending

Xolair.

I can no longer ignore Xolair as a valid treatment option for my son. I am

looking to get input from anyone who has had a child on Xolair as young as 5

or 6 years. What kind of difficulties can I expect with regard to getting

insurance coverage for this treatment? Are they likely to refuse coverage

based solely on his age? Anything else that I should know about the use of

Xolair in kids this young? Any information and guidance that you can give

will be must appreciated!

--

*Kendra Tiedemann*

October 13, 2010

--- In , Kendra Tiedemann <kendra.tiedemann@...>

wrote:

>

> Hello, everyone!

>

> I am the mother of a 5 year old with moderate persistent asthma and severe

> eczema which are closely tied to his food, pet and environmental allergies.

> He also has eosinophilic esophagitis (EoE). With the effects of each

> condition considered, ie is effectively allergic to every food that he

> has ever eaten with only one exception: cane sugar. His diet has, since

> August 2008, been limited to Neocate One Plus, Neocate Nutra, artificial

> colors and artificial flavors with cane sugar added back to his diet in

> December 2008. Attempts to reintroduce other foods have consistently

> failed. Occasionally, ie will outgrow a food allergy but then will

> quickly resensitize after eating it again for a matter of weeks. Perhaps

> most problematic is the airborne aspect of certain food allergies. Peeling

> oranges in his presence causes immediate bronchospasm, as does the use of

> orange-based cleaners. Cooking or reheating of eggs and pork cause

> wheezing, coughing and a flare of his eczema even if they are only minor

> ingredients. Peanuts and tree nuts will cause a rash and bronchospasm even

> without heating. This effectively prevents him from even walking into a

> grocery store from mid-November through the end of the year when bulk bins

> of nuts are unavoidable. After a recent increase in the frequency of

> airborne food reactions, ie now becomes quite anxious whenever he smells

> food and cleansers anywhere away from home. Contact reactions are also

> problematic, but easier to deal with. Allergy shots were initiated in June

> 2008 when outside time had to be limited to a cumulative 30 minutes per day.

> ie can now play outside for up to an hour at a time before the wheezing

> and coughing begin -- 90 minutes outside last week led to a flare of asthma

> and allergic rhinitis that we are still fighting.

>

> Medications that are currently in use are Pulmicort (nebbed once daily in

> the summer, twice daily otherwise), albuterol (nebbed at varying rates),

> Singulair (daily), Allegra (twice daily), Periactin (two to three times

> daily), Nasonex (once to twice daily), Benadryl (mostly for breakthrough

> hives and reactions at school), EpiPen Jr (used once, narrowly avoided too

> many times to count) and Orapred (roughly 5 to 7 days per month except in

> summer). Today was Day 4 of Orapred. ie's lungs are essentially clear

> of wheeze and crackle, but the bronchospasms continue. Daytime is bearable,

> but last night we were still doing neb treatments every 2 1/2 hours with

> plenty of coughing in between. I was up all night repositioning him because

> he couldn't catch a breath between coughs unless he was propped upright.

> Albuterol in his neb did help, but not completely and never for long. We

> added a nasal steroid today with the hope that doing so will allow us to

> avoid extending the Orapred beyond 5 days. I am not holding my breath...

>

> Historically, we have not pursued Xolair due to ie's age and because his

> quality of life was still pretty good. That is no longer the case. Now in

> kindergarten, he is noticing all that he misses out on due to airborne

> environmental and food allergens. The anxiety is new and very concerning,

> as he has always had a lot of self-confidence. Until very recently, ie

> was respectful of his allergens but not afraid of them. Now that he is in

> school full time, his education is being negatively impacted. He missed 6

> of the first 40 days of school and has had multiple early dismissals for

> medical appointments that could only be scheduled during the school day.

> Just as we get him caught up from one absence, he is out again. As of now,

> we have his pediatrician, a GI specialist and 2 allergists recommending

> Xolair.

>

> I can no longer ignore Xolair as a valid treatment option for my son. I am

> looking to get input from anyone who has had a child on Xolair as young as 5

> or 6 years. What kind of difficulties can I expect with regard to getting

> insurance coverage for this treatment? Are they likely to refuse coverage

> based solely on his age? Anything else that I should know about the use of

> Xolair in kids this young? Any information and guidance that you can give

> will be must appreciated!

>

> --

>

> *Kendra Tiedemann*

>

October 13, 2010

Hi my name is and my son Nolan started xolair in May of this year just one

month before turning 6. These shots have been a God send for him. Although he

is not as sick as your son. He does have severe asthma and allergies. We used

to use albuterol at least 3 times a day and we are now only using it 2 to 3

times a week. we have not had prednisone since right before starting the shots.

Nolan used to receive allergy shots but after having 6 severe reactions and the

last almost killing him his immunologist said we should try this. We had to

jump through a lot of hoops to get approved but thank God it was and our

insurance covers ALL of it. The first step is the blood work. His ige levels

had to be above a certain amount. The doctors and nurses at our local childrens

hospital are like our family. I love them to death and so does Nolan. They did

whatever it took to get him approved. Nolan is the youngest patient at the

hospital to receive the shots and he is only 1 out of 6 to receive them as well.

His pediatrician said he is the first patient they have ever had on it. The way

he has responded to the shots definitely out ways the risks the shots cause. I

know it is scarey but it is so worth it. I would be more than happy to answer

any questions, just email me.

Good luck,