Important safety information and consumer warnings you should know about epinephrine auto-injectors.
The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your health care provider and pharmacist. The full FDA-approved product labeling can be found at www.drugnamepi.com or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/ or call 1-800-FDA-1088.
Adrenaclick, Auvi-Q, EpiPen, and Symjepi (epinephrine) auto-Injectors are indicated for the emergency treatment of anaphylactic reactions in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. These medicines are designed as emergency supportive therapy only. They are not a replacement for subsequent medical or hospital care. After administration, patients should seek medical attention immediately or go to the emergency room and then for the next 48 hours, patients must stay within close proximity to a healthcare facility or where they can call 911.
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. You can read more about these products at the manufacturers websites for Adrenaclick, Auvi-Q, EpiPen®, and Symjepi, in our learning center article Important Safety Information - Epinephrine, and in the Treatment Plans we provide for you if we provide treatment.
Adrenaclick is an emergency injection ("shot") of epinephrine. It is a medicine used for life-threatening allergic reactions such as severe swelling, breathing problems, or loss of blood pressure.
Allergic reactions can be caused by stinging and biting insects (bugs), allergy injections, food, medicines, exercise, or unknown causes.
After using Adrenaclick go to your doctor or emergency room right away for more medical treatment.
Important Safety Information
Make sure to tell your doctor about all your medical conditions and allergies, but especially if you:
- Have heart disease or high blood pressure
- Have diabetes
- Have thyroid conditions
- Have asthma
- Have depression or other mental disease
- Have Parkinson's disease
- Are pregnant
- Are allergic to any of the ingredients in Adrenaclick
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some medicines may cause serious side effects if taken while you use Adrenaclick. Some medicines may affect how Adrenaclick works, or Adrenaclick may affect how your other medicines work. Diabetic patients may need to adjust the dose of their diabetes medicines or insulin after using Adrenaclick.
Avoid injecting Adrenaclick into your buttock or any other part of your body, other than the middle of the outer side of your thigh (upper leg). Avoid injecting Adrenaclick into a vein.
Too much Adrenaclick can cause dangerously high blood pressure, stroke, or death.
If you take certain medicines, you may develop serious life-threatening side effects from the epinephrine in Adrenaclick. Be sure to tell your doctor about all the medicines you take, especially medicines for asthma. Patients with certain medical conditions, or who take certain medicines, may get more side effects from Adrenaclick, or the side effects may last longer. This includes patients who take certain types of medicines for asthma, allergies, depression, hyperthyroidism, high blood pressure, and heart disease. Patients with heart disease may feel chest pain (angina).
Patients with mental disease or Parkinson's disease may have worsening symptoms of their illness. Adrenaclick can cause the following reactions.
Some reactions can be serious. They usually go away with rest. They include
- Faster, irregular (wrong) or "pounding" heartbeat
- Throbbing headache
- Feelings of over-excitement, anxiety, or fear
- Weakness or shakiness
- Nausea and vomiting
These are not all the possible side effects of Adrenaclick. For more information, ask your doctor or pharmacist.
Read this Patient Information Leaflet before you have to use AUVI-Q and each time you get a refill. There may be new information. You should know how to use AUVI-Q before you have an allergic emergency. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about AUVI-Q?
Always carry AUVI-Q with you because you may not know when a life-threatening allergic reaction (anaphylactic reaction) may happen. Talk to your doctor if you need additional units to keep at work, school, etc. An anaphylactic reaction is a life-threatening allergic reaction that can happen within minutes and can be caused by stinging and biting insects (bees, wasps, hornets, and mosquitoes), allergy shots, foods, medicines, exercise, or other unknown causes. Follow your healthcare provider’s instructions on when to use AUVI-Q if you have the symptoms of an anaphylactic reaction, which may include the symptoms listed below:
- Trouble breathing
- Hoarseness (changes in the way your voice sounds)
- Hives (raised reddened rash that may itch)
- Severe itching
- Swelling of your face, lips, mouth or tongue
- Skin rash, redness, or swelling
- Fast heartbeat
- Weak pulse
- Feeling very anxious
- Stomach pain
- Losing control of urine or bowel movements
- Dizziness or fainting
Tell your family members and others where you keep AUVI-Q and how to use it before you need it. You may be unable to speak in an allergic emergency. Get medical attention immediately after using AUVI-Q. If you have a serious allergic reaction, you may need more medicine.
What is AUVI-Q?
AUVI-Q 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.
AUVI-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using AUVI-Q. It is not known if AUVI-Q is safe and effective in children who weigh less than 16.5 pounds (7.5 kg).
What should I tell my healthcare provider before using AUVI-Q?
Before you use AUVI-Q, tell your healthcare provider if you:
- Have heart problems or high blood pressure
- Have diabetes
- Have thyroid problems
- Have history of depression
- Have Parkinson’s disease
- Have any other medical conditions
- Are pregnant or plan to become pregnant. It is not known if AUVI-Q will harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if AUVI-Q passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
AUVI-Q and other medicines may affect each other, causing side effects. AUVI-Q may affect the way other medicines work, and other medicines may affect how AUVI-Q works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use AUVI-Q?
Each AUVI-Q contains only 1 dose of medicine. AUVI-Q should only be injected into the muscle of your outer thigh. It can be injected through your clothing, if needed.
Read the Instructions for Use at the end of this Patient Information Leaflet for information about the right way to use AUVI-Q. Use AUVI-Q exactly as your healthcare provider tells you to use it. A Trainer for AUVI-Q with a separate Trainer Instructions for Use leaflet is included with AUVI-Q. Additional training resources are available at www.auvi-q.com. Practice with the Trainer for AUVI-Q before an allergic emergency happens to make sure you are able to safely use the real AUVI-Q in an emergency. The Trainer for AUVI-Q does not contain a needle or medicine and can be reused to practice your injection.
What are the possible side effects of AUVI-Q?
AUVI-Q may cause serious side effects. AUVI-Q should only be injected into your outer thigh. Do not inject AUVI-Q into your:
- Fingers, toes, hands or feet
If you accidentally inject AUVI-Q into any other part of your body, go to the nearest hospital emergency room right away. Tell the healthcare provider where on your body you received the accidental injection. 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 at an injection site:
- Redness that does not go away
- The area feels warm to the touch
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. Ask your healthcare provider to show you how to properly hold the leg of a young child or infant during an injection.
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. Talk to your healthcare provider about all your medical conditions.
Common side effects of AUVI-Q
- Fast, irregular, or ‘pounding’ heart beat
- Feelings of over excitement, nervousness, or anxiety
- Nausea and vomiting
- Breathing problems
About This Medicine
What the medication is used for: EpiPen® and EpiPen Jr® are indicated for the emergency treatment of anaphylaxis and are intended for people determined to be at risk for serious allergic reactions and for people with a history of anaphylactic reactions.
EpiPen® and EpiPen Jr® should be used immediately to treat yourself or your child when experiencing a severe allergic reaction. This is emergency treatment. It does not replace seeing a doctor or going to the hospital.
Anaphylaxis is the term for a severe, life-threatening allergic reaction. A severe allergic reaction occurs when a person is exposed to an allergen (an allergy-causing substance). When the allergen enters the body it triggers the releases of chemicals that can lead to life-threatening symptoms.
Some common allergens include:
- Foods like peanuts, tree nuts, shellfish, fish, milk, eggs, and wheat
- Insect stings like those from bees, wasps, hornets, yellow ackets, and fire ants
- Insect bites like those from mosquitos and black flies
- Certain medicines
- Other allergens (a substance that causes allergies)
- These severe allergic reactions can also be caused by exercise, asthma or by unknown causes.
Those who are considered to be at a higher risk of anaphylaxis include people:
- Who have previously experienced allergic reactions or anaphylaxis
- Who suffer from asthma
- Who have food allergies
Anaphylaxis affects multiple body systems: skin, upper and lower respiratory system, intestinal tract, heart and blood vessels.
The most common warning symptoms of anaphylaxis are:
- Hives and swelling
- Typical symptoms of anaphylaxis include:
- Swelling of the throat, lips, tongue, or the area around the eyes
- Difficulty breathing or swallowing
- Wheezing and cough
- Metallic taste or itching in the mouth
- Flushing, itching, or redness of the skin
- Stomach cramps, nausea, vomiting, or diarrhea
- Increased heart rate
- Decreased blood pressure
- Chest pain
- Irregular heart beat
- Sudden feeling of weakness
- Feeling faint
- Anxiety or an overwhelming sense of doom
- Loss of consciousness
What EpiPen Does
EpiPen® and EpiPen Jr® contain epinephrine, which is the medication that helps to decrease your body’s allergic reaction.
Some of the ways it works include:
- Relaxing the muscles in your airways so you can breathe more easily
- Helping to reverse the rapid and dangerous decrease in blood pressure
- Relaxing the muscles in your stomach, intestines, and bladder
What the medicinal ingredient is: Epinephrine.
What the nonmedicinal ingredients are: Hydrochloric acid, sodium chloride, sodium metabisulfite, and water for injection.
Warnings and Precautions
Before you obtain EpiPen® or EpiPen Jr®, talk to your doctor or pharmacist about all of your medical conditions, especially if you have:
- Heart disease
- Irregular heartbeat
- High blood pressure
- Thyroid conditions
- Narrow-angle glaucoma
- Depression or other mental disease
- Parkinson’s disease
- Severe kidney disease
- A tumor on the adrenal gland
- A tumor in the prostate gland
- Very high calcium levels in your blood
- Very low potassium levels in your blood
- Previously had an allergic reaction
- An allergy to any of the ingredients in this medication
- Are pregnant or breast feeding
Other Warnings You Should Know About
General: If have you had a severe, life-threatening allergic reaction in the past, you are at a higher risk for having one again. You should carry EpiPen® or EpiPen Jr® with you at all times. You or your child should also wear some form of medical identification bracelet or necklace.
Using EpiPen® or EpiPen Jr® does not replace seeing a doctor or going to the hospital. You must get medical help right away after you or your child has used it.
Patients with Asthma: if you or your child has asthma, and it is not controlled properly, you are at a higher risk of having breathing problems when you have a severe allergic reaction. EpiPen® or EpiPen Jr® contains metabisulfite. This can cause allergic reactions and bronchospasms in those with a history of asthma. You should follow your doctor’s instructions carefully on when you or child can use EpiPen® or EpiPen Jr®.
Injection site: You should ONLY inject EpiPen® or EpiPen Jr® into the outer side of your upper thigh - into the muscle (see Proper Use of this Medication). Do not inject it into the:
- Vein (intravenously (IV)
- Hands, fingers, feet and toes
If you do, it can either cause dangerously high blood pressure or you or your child may not get the effect of the emergency treatment that you or they need.
If you accidentally inject it into any of these areas, go right away to the nearest hospital (emergency room) for further treatment. If you inject a young child with EpiPen® or EpiPen Jr® hold their leg firmly in place and limit movement 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.
If you have a thick layer of fat under your skin the epinephrine in EpiPen® or EpiPen Jr® may not reach your muscle tissue. In some cases this might make EpiPen® and EpiPen Jr® not work as well.
Interactions with EpiPen
Drugs that may interact with EpiPen® or EpiPen Jr® include:
- Heart rhythm medicine, such as digoxin or quinidine (another name for digoxin is digitalis)
- Diuretic medicines ("water pills")
- MAO inhibitors (MAOI), such as selegilline,
- Isocarboxazid, phenelzine sulfate, or tranylcypromine
- Tricyclic antidepressants, such as amitriptyline, doxepin, nortriptyline
- Antihistamines, such as chlorpheniramine, tripelennamine, or diphenhydramine
- Beta-adrenergic blocking drugs, such as propranolol
- Alpha-adrenergic blocking drugs, such as phentolamine
- Ergot alkaloids and phenothiazines
- Isoproterenol, orciprenaline, salbutamol and LABAs
- Thyroid medications (e.g. sodium levothyroxine)
Proper Use of EpiPen
If you have been told by your doctor that you are at risk for an anaphylactic reaction, carry your EpiPen® or EpiPen Jr® with you at all times. When your doctor prescribes EpiPen® or EpiPen Jr®, you must make sure you understand the reason it has been prescribed for you. You should be confident that you know exactly how and when to use it. Use EpiPen® or EpiPen Jr® exactly how your doctor or pharmacist has told you. Ask to have the instructions repeated to you if you are unsure about how to use it. It is recommended that your family members, carers or teachers are also instructed in the correct use of EpiPen® or EpiPen Jr®.
There is a training device (Trainer) which you can use to practice. If you have been stung by an insect, try to remove the stinger with your fingernails. Do not squeeze, pinch or push the stinger deeper into the skin.
If possible, put an ice pack on the area of the sting. Keep yourself warm and avoid exercise. For allergic reactions caused by foods make sure you remove any remaining food from the mouth immediately.
Severe, life-threatening allergic reactions (anaphylaxis) can result in death if not treated immediately. Talk to your doctor about the warning signs and symptoms of anaphylaxis and when to use EpiPen® or EpiPen Jr®. Inject EpiPen® or EpiPen Jr® right away if you experience any of the symptoms of a severe allergic reaction, such as swelling of the throat, lips, tongue or around the eyes, trouble breathing or swallowing. You must get medical help right away after using EpiPen® or EpiPen Jr®. You can: call 911 and get taken to the hospital OR you can have someone take you (or you can take your child) to the nearest hospital emergency room. If you or your child do not feel better or get worse you can inject another dose of EpiPen® or EpiPen Jr® 5 to 15 minutes after the first injection. Do not inject more than 2 injections right after each other.
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
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.
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
- 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
- Feelings of over excitement, nervousness or anxiety
- 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.
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.