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Anaphylaxis Overview

What exactly is anaphylaxis?1

Anaphylaxis (an-uh-fuh-lak-sis) is a severe, life-threatening allergic reaction that requires immediate medical treatment. It can happen fast (sometimes within minutes), so having an epinephrine injection within reach is critical. While the possibility of a severe allergic reaction may be frightening, recognizing what is happening and knowing what to do may be what saves your life or your child’s life.

Symptoms of anaphylaxis1,2

Symptoms of anaphylaxis can vary by person and by cause but typically start between 5 and 30 minutes of coming into contact with the allergen. In some cases, it may take more than an hour for you to notice the symptoms. It is extremely important to treat a severe allergic reaction immediately. If not treated properly, anaphylaxis can be fatal.

Symptoms of anaphylaxis typically affect more than 1 part of the body and may include:

  • Itchy, red rash with hives
  • Swollen throat or other areas of the body
  • Wheezing, trouble breathing, and coughing
  • Passing out
  • Chest tightness
  • Hoarse voice
  • Trouble swallowing
  • Vomiting
  • Stomach cramping or diarrhea
  • Pale or red color to the face and body
  • A feeling of impending doom

Causes of anaphylaxis2

Anaphylaxis is triggered by exposure to an allergen. An allergen is a substance that is typically harmless but causes a reaction in people with an allergy. Causes of an anaphylactic reaction are different from person to person, but what happens is the same—the immune system overreacts to the allergen by releasing chemicals that cause allergy symptoms.

Food Allergens3

If you have a food allergy, your immune system overreacts to a particular protein found in that food. Symptoms can occur even if you have come in contact with a tiny amount of the food. Common food allergies:

  • Cow's milk
  • Eggs
  • Fish
  • Peanuts
  • Shellfish
  • Soy
  • Tree nuts
  • Wheat

Insect Allergens4

While most people develop redness and swelling at the site of an insect bite or sting, people who are allergic to stinging insect venom are at a much greater risk of having a serious, life-threatening reaction. Understanding the difference and getting an accurate diagnosis is very important so you can properly manage your allergy and stay prepared should an emergency happen. Common insect allergies:

  • Yellow jackets (black with yellow markings)
  • Honeybees (round, fuzzy bodies with dark brown and yellow markings)
  • Paper wasps (slender with black, brown, red, and yellow markings)
  • Hornets (black or brown with white, orange, or yellow markings)
  • Fire ants (reddish-brown ants living in large mounds, mostly in warmer climates)

Medicine Allergens5

An allergic reaction to a medicine is not the same thing as having a side effect. While all medications have the potential to cause a side effect, only 5% to 10% of these reactions are due to an actual allergy to the medicine. It is important to take all medicines exactly as your doctor prescribes and to speak with him or her if you have a reaction that concerns you. And, as always, seek medical attention immediately if you begin to have severe symptoms of an allergic reaction. Common medicine allergies:

  • Antibiotics, such as penicillin
  • Aspirin and nonsteroidal anti-inflammatory medicines, such as ibuprofen
  • Anticonvulsants
  • Monoclonal antibody therapy
  • Chemotherapy

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full Important Safety Information

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 SYMJEPI.
  • 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.

Please see full Prescribing Information for SYMJEPI.

To report SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals Corporation at 1-800-230-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Anaphylaxis. American Academy of Allergy Asthma & Immunology website. https://www.aaaai.org/conditions-and-treatments/allergies/anaphylaxis. Accessed October 14, 2020. 2. Symjepi [Prescribing Information]. San Diego, CA: Adamis Pharmaceuticals Corporation; 2019. 3. Food allergy. American Academy of Allergy Asthma & Immunology website. https://www.aaaai.org/conditions-and-treatments/allergies/food-allergies. Accessed October 14, 2020. 4. Stinging insect allergy. American Academy of Allergy Asthma & Immunology website. https://www.aaaai.org/conditions-and-treatments/allergies/stinging-insect-allergy. Accessed October 14, 2020. 5. Drug allergy. American Academy of Allergy Asthma & Immunology website. https://www.aaaai.org/conditions-and-treatments/allergies/drug-allergy. Accessed October 14, 2020.

Important Safety Information

Warnings and Precautions

  • You should get emergency medical care right away after using SYMJEPI.
For any supply questions, please call 1-800-230-3935
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