All Posts in Category: Support Group

U.S. FDA Approves Kaléo’s AUVI-Q® (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children

Richmond, VA (November 20, 2017) kaléo, a privately-held pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for AUVI-Q® (epinephrine injection, USP) 0.1 mg, the first and only epinephrine auto-injector (EAI) specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds (7.5 to 15 kilograms) who are at risk for or have a history of serious allergic reactions.

The sNDA for the AUVI-Q 0.1 mg Auto-injector was granted Priority Review by the FDA, an expedited regulatory pathway reserved for products that may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies.

AUVI-Q is a compact epinephrine auto-injector with industry-first features, including a voice prompt system that guides a user with step-by-step instructions through the delivery process, and a needle that automatically retracts following administration. The new 0.1 mg-dose epinephrine auto-injector has a shorter needle length and lower dose of epinephrine than current FDA approved 0.15 mg and 0.3 mg epinephrine auto-injectors.

Children are increasingly being treated for anaphylaxis. There was a 129.8 percent increase in emergency room visits for anaphylaxis among children four years old and younger between 2005 and 2014.i According to a study published in Allergy, Asthma & Clinical Immunology, 43 percent of children weighing 16.5 pounds (7.5 kilograms) to 33 pounds (15 kilograms) treated with a 0.15 mg EAI having a standard 12.7 mm needle length are at risk of having the needle strike the bone, therefore potentially impacting the administration of epinephrine during a life-threatening emergency.ii The needle length in AUVI-Q 0.1 mg was specifically designed for use with infants and small children to help mitigate this safety concern.

“Today’s decision by the FDA to approve the AUVI-Q 0.1 mg Auto-injector is exciting for all of us in the life-threatening allergy community who have been working for many years to fulfill this unmet medical need,” said Spencer Williamson, President and CEO of kaléo. “As a company that focuses on patients first, and providing potentially life-saving treatments, we are particularly glad we will be able to help caregivers by providing an EAI that was specifically designed with an appropriate dose and needle length for infants and children (16.5 to 33 pounds) in order to maximize the potential for a safe administration of epinephrine.”

“The approval of AUVI-Q 0.1 mg will help achieve our goal of working to fulfill unmet medical needs,” said Eric S. Edwards, MD, PhD, Vice President of Innovation and Research & Development at kaléo. “We developed the AUVI-Q 0.1 mg EAI to deliver a dose of epinephrine appropriate to infants and small children weighing 16.5 – 33 pounds, with a shorter needle length to help mitigate the risk of striking bone which could potentially cause injury or interfere with the delivery of epinephrine.”

Only AUVI-Q 0.1 mg has a dose and needle length designed specifically for treating anaphylaxis in infants and small children weighing 16.5 – 33 pounds. AUVI-Q 0.1 mg includes the innovative AUVI-Q electronic voice instruction system as well as visual cues to help guide users step-by-step through the administration.

“The approval of an epinephrine auto-injector specifically designed for infants and small children is timely, especially given the recent changes to guidelines recommending that certain high-risk infants, as young as four to six months old, be introduced to peanut-containing foods,” said Eleanor Garrow-Holding1, President and CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT). “We are pleased that the pediatric allergy healthcare community and parents of infants and small children with life-threatening allergies will have the ability to obtain an FDA-approved epinephrine auto-injector in the event of an allergic emergency. We look forward to the availability of AUVI-Q 0.1 mg.”

“Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine auto-injector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency,” said Dr. Vivian Hernandez-Trujillo1, a pediatric allergist, and fellow of the American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; and American Academy of Pediatrics specializing in the management of life-threatening allergies and anaphylaxis. “Having an epinephrine auto-injector with a needle length and dose specifically designed for infants and small children should help alleviate concerns around hitting the bone or injecting too much epinephrine.”

Identical twin brothers, Evan and Eric Edwards, the inventors of AUVI-Q, know what it is like to live with life-threatening allergies, both as patients and parents of food-allergic children. Their goal was to develop an epinephrine auto-injector that contained innovative features, such as a voice instruction system that helps guide patients and caregivers step-by-step through the injection process. Evan and Eric Edwards believe and trust in AUVI-Q, not only for themselves, but also for their children and other families who may have to depend on it to administer epinephrine during an allergic emergency.

The AUVI-Q 0.1 mg Auto-injector is projected to be available for patients in the first half of 2018.  To learn more about AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg), please visit

About Anaphylaxis

Anaphylaxis (pronounced ana-fuh-lak-sis) is a serious allergic reaction that happens quickly and may cause death. Anaphylaxis can occur as a result of exposure to allergens including tree nuts, peanuts, milk, eggs, fish, shellfish, soy, wheat, insect bites, latex and medication, among other allergens.

About AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg)

AUVI-Q (epinephrine injection, USP) Auto-injector is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a well-established, first-line treatment for severe, life-threatening allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.

AUVI-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. AUVI-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error.

For more information about AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg)  visit


AUVI-Q® (epinephrine injection, USP) is a prescription medicine used to treat life-threatening allergic reactions, including anaphylaxis, in people who are at risk for or have a history of serious allergic reactions.


Important Safety Information

AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. Seek immediate medical treatment after using AUVI-Q. Each AUVI-Q contains a single dose of epinephrine. AUVI-Q should only be injected into your outer thigh, through clothing if necessary. If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the injection to prevent injuries. Do not inject AUVI-Q into any other part of your body, such as into veins, buttocks, fingers, toes, hands, or feet. If this occurs, seek immediate medical treatment and make sure to inform the healthcare provider of the location of the accidental injection. Only a healthcare provider should give additional doses of epinephrine if more than two doses are necessary for a single allergic emergency.

Rarely, patients who use AUVI-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.
If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use AUVI-Q. Be sure to tell your healthcare provider about all the medicines you take, especially medicines for asthma. Also tell your healthcare provider about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, heart problems or high blood pressure, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related
(cardiac) symptoms.

Common side effects include fast, irregular or ‘pounding’ heartbeat, sweating, shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness, dizziness, nausea and vomiting, or breathing problems. These side effects usually go away quickly, especially if you rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Please see the full Prescribing Information and the Patient Information at

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.


About kaléo (kuh-LAY-oh)

Kaléo is a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions. Our mission is to provide innovative solutions that empower patients to confidently take control of their medical conditions. We believe patients and caregivers are the experts on how their medical condition impacts their lives and are an integral part of our product development process. Kaléo is a privately-held company headquartered in Richmond, Virginia. For more information, visit



Read More

Managing Your Child’s Food Allergy’s at School: Q&A with Lisa Musician, RD, LDN

book_parenting_a_positive_reaction_sm-1What motivated you to write this book?

I was motivated to write the book personally because I experienced firsthand what it was like to send a child off to school with food allergies, not just one child but two. As I continued to counsel more parents sending their children to school with food allergies and hearing the same questions, I felt it was necessary to reach out and help inspire parents to become confident about their ability to promote safe for their food allergy children and creating a sense of normalcy. I share my personal experiences throughout the book as well as my professional knowledge.

What advice do you have for a parent who has a child that is newly diagnosed with a food allergy?

I let the parent(s) know that they are not alone and there is a wealth of information on food allergies that I will help them navigate the process of learning how to keep their child safe while maintaining optimal health and keeping peace of mind. I share my personal experience which helps to ease their mind in knowing that they are working with someone who “gets it”.

Why is an Allergy Action Plan important for a child to have on file in school?

An emergency treatment or care plan (also known as a Food Allergy Action Plan or Allergy Action Plan) is a written plan of instructions based on recommendations from the child’s healthcare provider (allergist or physician managing the food allergies) that clearly states what to do if an allergic reaction happens. It’s an effective tool for communicating the necessary steps to respond appropriately to a potentially life-threatening food allergy reaction. There’s no guess work if a reaction happens, the plan spells out exactly what to do. The plan should include: basic information (name, address, contact number of parents, age, height & weight of student, date of birth, grade and teacher’s name along with emergency contact numbers listed in order of importance to be called; type of action to be taken in an emergency which would include: instructions on how and when to administer medications, list of medications, including dosage and route (oral, injection, etc.); and a list of signs and symptoms of an allergic reaction.

What is a common mistake you often see with food allergy management?

The most common mistake with food allergy management is poor recognition of allergic symptoms and subsequent failure to treat immediately with epinephrine. Delaying treatment is life threatening. When there is a question of whether or not to give epinephrine, it is best to err on the side of administering. If medication is not given within a certain amount of time after the onset of anaphylaxis, the probabilities of survival are decreased dramatically.

How can parents best partner with a school to insure their child’s food allergies are managed safely and successfully?

This is exactly why I wrote my book. To help parents partner with the school to insure their child’s food allergies are managed safely and successfully by learning how to effectively communicate by asking the questions necessary to keep their child safe. For instance, parents are encouraged to ask under what circumstances food would be in the classroom and how often. Also, ask what the snack policy is for the classroom. These are just some of the questions found in my book. Education, communication and preparation are the essential keys in managing food allergies at school. It’s a team approach between the parents, school and child.

How can we best support families with food allergies?

Some simple tips to help support families with food allergies at school and outside of school is to offer non-food items instead of food, encourage non-food activities like playing a game or taking a walk as a way of spending time together. Simply asking what you can do to help can make all the difference to the food-allergic child and his or her parents.

Any other takeaways?

Keeping food-allergic children safe at school with food allergies is manageable. Parents are the greatest supporters and advocates. It’s important to understand and believe that having a food allergy is only one part of a child’s life. A healthy outlook is to focus on the positives and possibilities life has to offer. Promoting safe care while creating a sense of normalcy at school is possible. I would encourage anyone sending a child to school with food allergies to read my book, Parenting a Positive Reaction.

Lisa’s book can be found on in paperback.

Read More

11/15/2016 – Special Food Allergy Event – Linda Coss Speaker

I do not normally make a big deal about Food Allergy Meetings but we are very fortunate to have Linda Coss come and speak at our Food Allergy Group tonight.  You will not want to miss this opportunity.

Linda Coss has been a pioneer in the food allergy world, a speaker at the 2016 Food Allergy Bloggers Conference in November and is the author of four books:  75 Marketing Tips to Grow Your Business; How to Manage Your Child’s Life-threatening Food Allergies: Practical Tips for Everyday Life; What’s to Eat? The Milk-Free, Egg-Free, Nut-Free Food Allergy Cookbook; and What Else is to Eat? The Dairy-, Egg- and Nut-Free Food Allergy Cookbook.

Linda will be speaking on the topic of “Raising a Child Who Takes Life-Threatening Food Allergies in Stride”

As parents, we’re all striving to raise happy, well-adjusted children. Most parents will tell you that trying to achieve this goal can be a real challenge. And that’s without overlaying the challenges that we face as parents of children with life-threatening food allergies!

In this 20- to 25-minute talk, nationally-known food allergy author Linda Coss discusses how to handle daily food allergy management in such a way that your child grows up feeling completely comfortable with the reality of his or her allergies, accepts the situation without serious emotional trauma, and turns out “well-adjusted” in spite of it all. It’s a 10-step approach, and it all starts with the recognition that you, as the parent, set the tone and teach by example.

Linda will be available to answer questions and join in our food allergy discussion.  As always, new people are always welcome and we cannot provide any child care  Our meeting will begin at 6:30 PM in the Ministry Office 2 building.

To find the Church Office please visit the website:

For detailed directions from Google Maps, please visit here:


Read More

Costco let me down…but only for 2 weeks

It is interesting when you have kids with food allergies because you come to realize that your semi-controllable ritual is what you rely on most in your day.  You live your life like a scientist in that you want things that “work” and do not cause “allergic reactions” to become the norm.  You want things to remain the same from day to day.  Take something as simple as Almond Milk.  For those of us with kids with food allergies to milk (and not almonds), the Blue Diamond Almond Breeze Unsweetened Vanilla almond milk has been a staple in our home for almost 8 years now.  After trying a number of different “non-milk” alternatives, our family settled on the almond milk product.  And honestly, so did I.

It is actually a great milk substitute for a number of reasons but one of the biggest ones is that it has 0 grams of sugar.  This is a big one because if you are required to substitute one product (low-fat milk) for another (almond milk), your hope is that you would have a healthier solution than your initial choice.  And for our family, it was definitely that.

Now fast forward to the beginning of September 2016.  On a typical Sunday afternoon Costco run, as we are checking off our Costco list of essentials for the week, we head down the aisle that would normally carry the Almond Breeze almond milk.  After searching a bit and then re-checking the end-caps to see if it had moved, it was no where to be found.  They were out….or so I thought.

After we checked out, I went over to speak with one of the managers at a terminal and I was shocked to learn that they were not carrying the brand any more.  WHAT?  HOW COULD THIS BE?  After all these years….no more.  Being the persistent person that I am, the next day I reached out to Blue Diamond and sent an email.  Additionally I sent an email to Costco.  And then, I received back the bad news I was hoping to not receive.

Thank you for contacting Blue Diamond Growers. We appreciate your feedback and sorry that Almond Breeze is no longer at your Costco. Unfortunately this was a decision made by Costco. We will certainly pass along your comments to our Marketing and Sales team that work directly with Costco. You can also help us by going to the Members desk and requesting the Store Manager to please bring back Almond Breeze. Meanwhile I can send you some money saving coupons for your efforts and dedication to Almond Breeze.

ARGGG!  This is a bad dream.  Does this mean that as a food allergy parent I am actually going to have to shop at Whole Foods (sorry…..but no offense) to buy another “specialty” item that is going to add another large expense to my monthly bill.  In an act of desperation, I did notice that there was another “almond milk” product that Costco was carrying….but after bringing it home, my wife quickly pointed out the fact that it was “non-vanilla” and contained “a ton” of sugar.  This would have to go back.

Now fast forward to today.  After a last minute Costco run this evening, and after checking out, I decided to speak with a manager again about the almond milk situation.  My plan was simple.  If I could find a location that had the product, I would just drive there and buy several hundred dollars worth of almond milk.  Why not?  It has a huge shelf life (usually more than 1 year) and if it meant that I was going to save a lot of money then I would be completely justified in my decision (even though I would most likely hear a long speech from my wife on my insane decision).

The manager types at his computer a moment to tell me what I already knew.  The Blue Diamond brand was no more…but then he said something interesting.  He said that there was an “alternative” Kirkland product.  Huh?  What did that mean?  So, I politely asked if he could show me what he was referring to and guess what.  There it was.   In a NEW BOX.  A NEW product I have not seen before.  A KIRKLAND REPLACEMENT for the Blue Diamond Product.

And now….Thank You Costco.  You have just launched “Organic Unsweetened Non-Dairy Vanilla Almond Milk).  When you look at the packaging it is clear that it is being marketed for the Smoothie market….but that does not matter to me.  It is the same package….at the same price.  Thank you Costco.  Thank you Costco.  Thank you Costco.

As you can see by the photos, the product seems to be identical.  Next time you are at Costco, if you have been searching high and low for the almond milk, the love for Costco has returned.





Read More

Time for a New Name for Food Allergies

I had an interesting conversation with my wife the other day on the topic of Food Allergies.  It is interesting because every parent that engages in the daily battle of managing food allergies for their child is an amazing Hero in my opinion.  These are the parents that wake up every day and help their kids manage the not-so-wonderful world of food allergies.  And let me also make it clear that this article is not meant to discount or discourage those families with suffer from Celiac Disease, EOE, Gluten-Free or other food-type disorders.  We are talking about life-threatening food allergies.  For us parents battling the Food Allergy war, we can clearly understand the daily battles that ensue with your children and the difficult choices that have to be made daily as your kids choose was to eat several times throughout the day.  It is an emotional battle that occurs every day.

But one of the biggest gripes I have with Food Allergies is the issue with the name itself….Food Allergy and here is the basic problem.  The name itself does not properly communicate the incredible risk of life that is involved with every meal.  How many times as a parent have you heard the words “I also get an upset stomach after drinking milk” after you have explained to the stranger at the food counter that your child has a food allergy.  As a parent, I would love to have the issues of Diarrhea, Indigestion, Nausea or Vomiting.  I would absolutely welcome any of these side effects over the fear of immediately stop-breathing symptom.  Having different symptoms would be like a SPRING DAY filled with butterflies, deer, bacon and harps playing music in the background (okay, maybe the harps would be replaced with a Ukulele)….but you get the idea.  It would be amazing.


But no.  When your child has a life-threatening food allergy (and in the cases of most of the people that get to visit our support groups we are talking multiple life-threatening food allergies), this is not the case.  It can lead to DEATH without intervention.  It can happen QUICKLY.  It can happen without major visual symptoms.  Close your eyes for a moment and imagine yourself at one of your favorite restaurants looking through the menu.  As you scan through the items of that menu, most of the items have a little icon next to them with the words “Eating this will lead to DEATH”.  What would that be like?  Would you still want to eat there?  Would you trust the food that arrives on your plate?  Now imagine that it is not you but your child.  Walk through the above questions again and that is what these parents go through multiple times per day:  at the grocery store, at coffee shop, at home, at Grandmas, at School. etc. etc. etc.

Welcome to the very-difficult-world of what it is like for a parent of a kid with food allergies.  This is the daily routine that they face during every meal, through every day, with their children.  What if you have two children with food allergies (like many of us do)….then the very-difficult-world is multiplied exponentially.  It is the simple process of eliminating foods from their kid’s diets that will lead to death.  It is a tremendous burden and a thankless job.  It is a job that is done every day by thousands of parents (mainly moms and caregivers) each and every day.  But as we go through this minefield, we must constantly remind those around us at what is at stake for our children.  This is serious business with serious consequences.

It was interesting because I was listening to some of the recent horrific news about some of the recent attacks in France.  Absolutely terrible and our prayers go out to those families impacted.  As I listened, there was a story of one of the FBI officials talking about it and how they prepare for presidential speeches and events.  Simply said, the FBI needs to get things right 100% of the time.  There can be no mistakes.  This resonated with me that the same thing happens 50 times a day by every parent with a kid with food allergy.  They can never be wrong….ever.  Not even once.

So this leads me back to my original conversation with my wife on the topic of Food Allergies.  We need to come up with something better for this disease.  If it was called “INSTANT DEATH DISEASE FROM FOOD” or “MY KID WILL STOP BREATHING IF I EAT THAT DISEASE” or anything that instantly communicates the extreme importance of it then I would be complete favor of that.  Think about how much easier the conversations at school would be with those parents that insist that it is their right to bring a PB&J sandwich into the classroom.  The uncomfortable conversations at family gatherings where some relative insists on putting out the bowl of life-ending nuts on the table for everyone (but your child) to enjoy.  It the label for “Food Allergy” was just somehow different and could immediately described the emotion and the importance of the subject.

So if you are a parent without a kid with food allergy and you hear those words Food Allergy, please remember what is at stake for these parents.  It is not fatigue or indigestion that is at stake.  It is a child’s life that can be taken very quickly with the simple ingestion of a harmless looking cookie.

For now, I would continue to refer to Food Allergy as “A Life Threatening Food Allergy” until someone comes up with a better name.

Read More

March 2016 Support Group Meeting

If you are a parent of a child with food allergies, we invite you to our March 2016 food allergy support group meeting.  Designed for parents with kids with food allergies, our meetings (that meet every other month), help support parents with a wide range of food allergy topics.  The goal of the meeting is to provide a safe place where parents can share their concerns with other parents that can understand their food allergy situation.

According to FARE, researchers estimate that nearly 15 million Americans have food allergies and that nearly 1 in every 13 children.  This means that with roughly two children in every classroom, food allergies affect many families in Orange County.  Our goal is to provide a safe place to address this need.

In addition to speaking on Food Allergies, our group this month will continue the discussion of Oral Immunotherapy (OIT), which is a very popular topic.  Many of the families that attend our support group have first hand knowledge on some of the OIT programs that available and are more than happy to answer any questions that you may have.

We hope that if you have a child with food allergies that you will decide to visit us Tuesday, March 16, 2016 at 6:30 PM.  Our meeting will be at Saddleback Church in the Ministry Office 2 building.  For directions, please visit us online at:

Read More

Dr Randhawa and OIT Treatments

Food allergy is an abnormal reaction of the immune system that occurs soon after eating specific foods. The immune system overacts to the proteins found in that food. Even a very tiny amount of the allergic food can trigger digestive problems, hives and swollen airways. In some cases, these reactions can be so severe that they cause life-threatening anaphylaxis.

Read More

2015 FARE National Food Allergy Conference – Save the Date

May 16-17, 2015

The FARE National Food Allergy Conference will be held May 16-17, 2015 at the Hyatt Regency Long Beach in Long Beach, CA, gathering the country’s leading food allergy experts and members of the food allergy community together for a weekend of world-class programming. The conference provides a unique opportunity for individuals and families managing food allergies, caregivers, school staff, health care professionals and others interested in the field to gather as a community and learn about advances in food allergy research and advocacy, best practices and practical skills for living well with food allergies, and much more. Individuals 11 years and older are invited to join. Both full conference and single-day registrations will be available.

For more information, please visit:

Read More

Great Orange County Ice Cream Option for Kids with Food Allergies

So the family decided to check out Sub Zero Ice Cream and Yogart in Laguna Niguel, CA this evening.  Our oldest has a life threatening food allergy to milk, so our typical options when going out for after dinner treats usually involve those in the sorbet variety.  But tonight was different.






The good news is that this place really paid special attention to our food allergy.  Additionally, they use Almond Milk in many of their options.   Additionally, this is nice if you are concerned about calories and trying to make healthier choices.

Sub Zero is a great option for those who have food allergies.  In fact one of their posters even mention the wood “food allergies” in the print….nice.  Additionally, it is fun.  Basically after your ingredients are selected, the real fun begins.  -321 degrees of pure Nitrogen turning your bowl into custom ice cream before your eyes.

The only Orange County location is in Laguna Niguel, about 2 miles off the 5 freeway at the Oso exit.

SubZero Ice Cream and Yogart
27281 La Paz Road, Ste Q
Laguna Niguel, CA 92677

Check it out for yourself:


Read More