How to protect your children from life-threatening allergies

(BPT) - As a parent or caregiver, you do everything you can to keep your children safe, happy and healthy. You do your best to plan for the expected, but it's usually the unexpected that can have the most impact.

Terry Barnhart knows this all too well.

"Both of my daughters have nut allergies," says Barnhart. "My oldest, Fiona, so severe that she was rushed to the hospital on several occasions. We always carry at least two epinephrine injections everywhere we go."

He describes Fiona’s first severe allergic reaction as frightening.

"The first time she went to the hospital was because she had a severe allergic reaction to eating just one crumb that fell off a friend’s plate. She was six years old at the time, and got very red and started complaining she couldn’t breathe. As a parent, when your child can't breathe, it is terrifying. We immediately administered an epinephrine injection and rushed to the hospital."

After this hospital visit Barnhart and his wife, Helen, became paranoid about her safety, and always try to be as proactive as possible. From that point forward, they have taken precautions to protect both of their daughters by looking at all ingredients in everything they eat, and making sure restaurants are aware of their food allergies when dining out. They keep their house free of nuts and always carry two epinephrine injections at all times, in case one doesn't work correctly or a second dose is needed.

Food and other potentially life-threatening allergies are common in the United States. Reactions can be mild or severe. One in 50 Americans is at risk for anaphylaxis, a severe reaction that affects the whole body and can even lead to death if left untreated, according to the Asthma and Allergy Foundation of America.

Each year in the U.S., 200,000 people require emergency medical care for allergic reactions to food, according to Food Allergy Research and Education. For many of these people, carrying an epinephrine injection is vital to ensuring they have a life-saving treatment if they have a severe allergic reaction.

Due to a nationwide shortage of this emergency medicine from several drug manufacturers, many families are scrambling to find it, or go without it, leaving loved ones vulnerable to anaphylaxis. Fortunately, one company is taking steps to change this reality.

Sandoz, a Novartis division, recently launched SYMJEPI™ (epinephrine) 0.3 mg and 0.15 mg injections, making both the adult and pediatric doses immediately available in local pharmacies across the nation. SYMJEPI is a small, single-dose, pre-filled syringe and device combination as an alternative to epinephrine auto-injectors for the emergency treatment of allergic reactions (Type 1), including anaphylaxis. Please see Important Safety Information for SYMJEPI below.

The SYMJEPI device is small in size and fits into the palm of your hand, with the goal of a simple-to-use application and intuitive, user-friendly design. It has a smaller needle than the most widely used epinephrine auto-injectors. The availability of SYMJEPI may provide confidence to patients given its ease of use, ability to see the medicine as it is being delivered, small size to encourage it being on-person when needed, and confidence there is no shortage of supply. Learn more at www.symjepi.com.

Barnhart is happy that a new treatment option is available. He says that having additional epinephrine suppliers means it’s less likely there will be interruptions in the availability of this critical medicine, but also that competition typically means prices will drop.

"In the fall, you need a new pair of epinephrine injectors for school and a pair for your home – and every parent is buying them at the same time. It's a burst before school that exacerbates the shortage. This really is a great time to have a new option to protect our kids," says Barnhart.

* Barnhart works at Sandoz, Inc. but his story and opinions are his own and not provided on behalf of his employer.

Indication

SYMJEPI is indicated in the emergency treatment of allergic reactions (Type 1) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

Important Safety Information

CONTRAINDICATIONS

None

WARNINGS AND PRECAUTIONS

  • You should get emergency medical care right away after using the product.
  • You may need to use a second SYMJEPI (epinephrine) injection if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
  • Symjepi should only be injected into the middle of your outer thigh (upper leg) with the needle facing downwards. Never inject into any other part of the body. If you accidentally inject SYMJEPI into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection. Symjepi can be injected through your clothing if needed.
  • The needle cap on the SYMJEPI prefilled syringe helps to prevent needle sticks and accidental injection of epinephrine. Do not remove the needle cap until you are ready to use it.
  • Never put your thumb, fingers, or hand over the exposed needle.
  • If an accidental injection happens, get medical help right away.
  • Do not drop the carrier case or SYMJEPI prefilled syringe. If the carrier case or prefilled syringe is dropped, check for damage and leakage. Dispose of the prefilled syringe and carrier case, and replace if damage or leakage is noticed or suspected.
  • Do not place patient information or any other foreign objects in the carrier case with the prefilled syringe, as this may prevent you from removing the prefilled syringe for use.
  • If you inject a young child with SYMJEPI, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during injection.
  • Before using SYMJEPI, tell your healthcare provider about all of your medical conditions, including if you:
    • have heart problems or high blood pressure.
    • have diabetes.
    • have thyroid problems.
    • have asthma.
    • have a history of depression.
    • have Parkinson’s disease.
    • are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.
    • are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

ADVERSE REACTIONS

Symjepi may cause serious side effects.

  • Rarely, patients who have used SYMJEPI 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 at an injection site:
      • redness that does not go away
      • swelling
      • tenderness
      • the area feels warm to the touch
  • Cuts on the skin, bent needles, and needles that remain in the skin after the injection, have happened in young children who do not cooperate and kick or move during the injection.
  • If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your SYMJEPI. Talk to your healthcare provider about all your medical conditions.

Common side effects of SYMJEPI include:

  • fast, irregular or “pounding” heartbeat
  • sweating
  • headache
  • weakness
  • shakiness
  • paleness
  • feelings of over excitement, nervousness or anxiety
  • dizziness
  • nausea and vomiting
  • breathing problems

These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of SYMJEPI. For more information, ask your healthcare provider or pharmacist.

DRUG INTERACTIONS

  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • Tell your healthcare provider of all known allergies.
  • Especially tell your healthcare provider if you take certain asthma medicines.
  • SYMJEPI and other medicines may affect each other, causing side effects. SYMJEPI may affect the way other medicines work, and other medicines may affect how SYMJEPI works.
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

See full Prescribing Information for additional safety information.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For more information, visit the SYMJEPI website (https://www.symjepi.com/) and view the instructional video on how to use the injection device.

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