New Ragweed Under the Tongue Pill Instead of Allergy Shots Recommended by FDA Panel

Yesterday, the FDA Allergenic Products Advisory Committee supported approval for a new sublingual allergy tablets (Ragwitek) that work the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Given this is only a panel recommendation, final "official" FDA approval may not occur for another year or so for sale/distribution under prescription in the United States.

Ragwitek is made by ALK-Abello and Merck and treats patients aged 18-65 years who are allergic to only short ragweed pollen. The way Ragwitek is taken is placement of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the ragweed pollen season. The first dose is given in a medical office to ensure safety with all other doses taken at home. The tablet dissolves in less than 10 seconds.

Epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Ragwitek is similar to Oralair and Grastek which treat only grass allergy. Oralair and Grastek were both recommended by the FDA panel last year.

Source:
Sublingual Ragwitek Backed FDA Panel for Ragweed Allergy. Medscape 1/28/14

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Two New Sublingual Allergy Tablets Approved by FDA Advisory Committee

This week, the FDA Allergenic Products Advisory Committee unanimously supported approval for two new sublingual allergy tablets (Oralair and Grastek) that work the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Although both tablets have been available in Europe for some time, final "official" FDA approval may not occur until end of 2014 (or later) for sale/distribution under prescription in the United States.

Oralair is made by a French pharmaceutical company Stallergenes and treats patients aged 10-65 years who are allergic to 5 different grasses: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Treatment is composed of a buildup and maintenance phase. Starting 4 months prior to the grass pollen season, a 100 IR tablet is administered under the tongue in a medical office to ensure no significant side effects. At home on day 2, two 100 IR tablets are administered. On day three and daily thereafter, a 300 IR tablet is placed under the tongue until the end of the grass pollen season. The tablets take about 1 minute to dissolve.

Grastek (aka Grazax in Europe) is made by ALK-Abello and Merck and treats patients aged 5-65 years who are allergic to only Timothy Grass. Grastek has a simpler regimen of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the grass pollen season. As with Oralair, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

For both tablets, epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Sources:
Grastek Recommended by FDA Panel for Timothy Grass Allergy. Medscape 12/12/13

Sublingual Oralair Recommended for Grass Pollen Allergy. Medscape 12/11/13

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Another Egg-Free Flu Vaccine Approved by FDA

First there was Flucelvax introduced in 2012 and now there is Flublock, both considered egg-free for those concerned with egg allergy in traditional flu vaccines.

Rather than being cultured in eggs, Flucelvax is cultured in mammalian cells and Flublock is grown in caterpillar cells injected by an insect virus containing the flu gene.

Both vaccines are approved for use in people 18 years and older.

Why the concern of egg-allergic patients with the traditional flu vaccine used to defend against both seasonal and pandemic flu virus?

Traditionally, the flu shot vaccine (both H1N1 and seasonal) are grown inside eggs which is where this concern arises. It also doesn't help that the pre-flu shot questionnaire specifically asks about egg allergy. Though egg-based, during vaccine production the egg protein is filtered out such that there should be no egg contaminants in the final vaccine. However, it is theoretically possible that some egg may still be present in the vaccine.

Although there is an infinitesimal possibility of egg contaminants, studies have shown that even patients with life-threatening egg allergy can still safely have the flu vaccine.

In spite of these reassurances, there are still concerns from patients and healthcare professionals which makes the availability of two different egg-free flu vaccines welcome news.

Source:
FDA approves next-generation, bug-based flu vaccine. MSNBC 1/16/13

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Egg Free Flu Vaccine Approved by FDA

Why the concern of egg-allergic patients with the flu vaccine used to defend against both seasonal and pandemic flu virus?

Traditionally, the flu shot vaccine (both H1N1 and seasonal) are grown inside eggs which is where this concern arises. It also doesn't help that the pre-flu shot questionnaire specifically asks about egg allergy. Though egg-based, during vaccine production the egg protein is filtered out such that there should be no egg contaminants in the final vaccine. However, it is theoretically possible that some egg may still be present in the vaccine.

Although there is an infinitesimal possibility of egg contaminants, studies have shown that even patients with life-threatening egg allergy can still safely have the flu vaccine.

In spite of these reassurances, there are still concerns from patients and healthcare professionals.

As such, there is now a new FDA-approved flu vaccine called Flucelvax which is guaranteed to be egg-free. Rather than being cultured in eggs, this vaccine is cultured in mammalian cells.

Downside is that latex-allergic patients are unable to safely receive this vaccine.

Made by Novartis, this vaccine is approved for use in people 18 years and older.

For more info.

Source:
FDA approves first seasonal influenza vaccine manufactured using cell culture technology. FDA 11/20/12

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Is Flu Shot Safe for Patients With Egg Allergy?

It is the season for flu shots... and with that... we invariably get phone calls from patients asking whether it is safe to receive the flu shot if they are egg allergic. Generally speaking, the blunt answer is that it is safe... even if you have a life-threatening egg allergy.

Why the concern? The flu shot vaccine (both H1N1 and seasonal) are grown inside eggs which is where this concern arises. It also doesn't help that the pre-flu shot questionnaire specifically asks about egg allergy. Though egg-based, during vaccine production the egg protein is filtered out such that there should be no egg contaminants in the final vaccine. However, it is theoretically possible that some egg may still be present in the vaccine.

Given the infinitesimal possibility of egg contaminants, is the concern still legitimate?

There has been a recent study by Canadian researchers who followed 367 egg-allergic people, mostly children, who got the flu shot over five years. Almost one-third of these patients had a significant history of anaphylaxis after eating eggs causing serious symptoms like trouble breathing or a drop in blood pressure. However, in this study, NOT ONE of those patients, experienced a serious reaction to the flu vaccine. Only 13 of the 367 had mild "allergy-like" symptoms, like itchy skin or hives, within a day of the shot.

Furthermore, numerous past studies that involved close to 4,000 egg-allergic people who got the flu shot revealed not a single case of a serious allergic reaction.

However, if such studies still do not alleviate anaphylaxis concern if egg-allergic...

You can either get one of the new completely egg-free flu vaccine Flucelvax or Flublock or...

To play it safe, the absolute safest way for a patient with egg allergy to get the flu shot is via a few steps:

1) Get a test dose of the flu vaccine where a small amount (0.025cc typically) of the flu vaccine is administered sub-dermally.
2) Wait 10-20 minutes.
3) If there's no reaction (redness and swelling of the skin), get the shot properly into the muscle.
4) If there's a large wheal reaction, it's probably best not to get the flu shot or see an allergist to get desensitized prior to receiving the injection.
5) If flu shot given, make patient wait 30 minutes to observe for any adverse reaction.

Not all practices may be familiar with these particular steps. If that's the case, request to take the flu vaccine to an allergy office (including ours), and have us administer it. (Please note that we do not provide egg desensitization.)

If you are only IgG allergic and not IgE allergic to egg, no need to worry. Get the flu shot.

For a more in depth discussion, click here to read a document prepared by the American Academy of Allergy Asthma & Immunology.

Reference:
Egg-allergic patients can be safely vaccinated against influenza. Journal of Allergy and Immunology. In Press. Published Online Oct 1, 2012

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Why Does EpiPen Have to be Injected into the Thigh?

As any severely food allergic patients know, when suffering from a potentially life-threatening anaphylactic reaction, they need to jab an epinephrine needle into the side of their thigh...

But... why the thigh? Why not the arm like most other shots?

Per AAAAI, there have been 3 anatomic sites investigated to determine which location offers the fastest systemic absorption of epinephrine when injected intramuscularly and/or subcutaneously.

• Intramuscular injection in the upper arm (deltoid muscle) just like a flu shot.
• Subcutaneous injection in the upper arm just like an allergy shot.
• Intramuscular injection in the lateral thigh (vastus lateralis muscle).

Of these sites, the intramuscular thigh injection demonstrated the fastest rise in blood epinephrine.

When dealing with a life-threatening anaphylaxis, you need the speed because if the drug is too slow, the person may die before adequate epinephrine levels are achieved... and the thigh muscle provides the speed whereas the other sites do not.

Why might that be?

It's probably because the thigh muscle is large with lots of blood vessels allowing for multiple points of access for the injected epinephrine to enter into the blood circulation.


References:
Epinephrine absorption in children with a history of anaphylaxis. J Allergy Clin Immunology 1998; 101(1):33-37.

Epinephrine absorption in adults: intramuscular versus subcutaneous injection. J Allergy Clin Immunol 2001; 108(5):871-873.

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