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ADRENACLICK®
(epinephrine) Injection, USP
Adrenaclick (epinephrine injection, USP) auto-injector 0.3 mg and 0.15 mg is an auto-injector and a combination product containing drug and device components.
Each Adrenaclick 0.3 mg delivers a single dose of 0.3 mg epinephrine from epinephrine injection, USP (0.3 mL) in a sterile solution.
Each Adrenaclick 0.15 mg delivers a single dose of 0.15 mg epinephrine from epinephrine injection, USP (0.15 mL) in a sterile solution.
Adrenaclick 0.3 mg and Adrenaclick 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for Adrenaclick 0.3 mg and Adrenaclick 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded.
Each 0.3 mL in Adrenaclick 0.3 mg contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
Each 0.15 mL in Adrenaclick 0.15 mg contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.
Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:
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Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace Adrenaclick if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.
Thoroughly review the patient instructions and operation of Adrenaclick with patients and caregivers prior to use [see PATIENT INFORMATION].
Adrenaclick® is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which includes 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.
Adrenaclick is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria, or angioedema.
Adrenaclick is intended for immediate administration as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.
Selection of the appropriate Adrenaclick dosage strength is determined according to patient body weight.
Inject Adrenaclick intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Instruct caregivers of young children who are prescribed an Adrenaclick and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see WARNINGS AND PRECAUTIONS].
Each Adrenaclick contains a single dose of epinephrine for single use injection. Since the doses of epinephrine delivered from Adrenaclick are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated.
With severe persistent anaphylaxis, repeat injections with an additional Adrenaclick may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see WARNINGS AND PRECAUTIONS].
The epinephrine solution in the viewing window of Adrenaclick should be inspected visually for particulate matter and discoloration. Epinephrine is light sensitive and should be stored in the outer case provided to protect it from light [see HOW SUPPLIED/Storage and Handling].
Carton containing two Adrenaclick (epinephrine injection, USP) 0.3 mg auto-injectors: NDC 52054-804-02.
Carton containing two Adrenaclick (epinephrine injection, USP) 0.15 mg auto-injectors: NDC 52054-803-02.
Protect from light. Epinephrine is light sensitive and should be stored in the carrying-case provided to protect it from light. Store at room temperature (20° to 25°C (68° to 77°F)); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate. Before using, check to make sure the solution in the auto-injector is clear and colorless. Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.
Manufactured for and Distributed by: Amedra Pharmaceuticals LLC, Horsham, PA 19044. Revised: May 2016
Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.
Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see WARNINGS AND PRECAUTIONS].
Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see WARNINGS AND PRECAUTIONS].
Angina may occur in patients with coronary artery disease [see WARNINGS AND PRECAUTIONS].
Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see WARNINGS AND PRECAUTIONS].
Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.
Lacerations, bent needles, and embedded needles have been reported when Adrenaclick has been injected into the thigh of young children who are uncooperative and kick or move during an injection [see WARNINGS AND PRECAUTIONS].
Injection into the buttock has resulted in cases of gas gangrene [see WARNINGS AND PRECAUTIONS].
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [see WARNINGS AND PRECAUTIONS].
Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see WARNINGS AND PRECAUTIONS].
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.
The cardiostimulating and bronchodilating effects of epinephrine are antagonized by betaadrenergic blocking drugs, such as propranolol.
The vasoconstricting and hypertensive effects of epinephrine are antagonized by alphaadrenergic blocking drugs, such as phentolamine.
Ergot alkaloids may also reverse the pressor effects of epinephrine.
Included as part of the PRECAUTIONS section.
Adrenaclick is intended for immediate administration as emergency supportive therapy and is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION and PATIENT INFORMATION].
Adrenaclick should only be injected into the anterolateral aspect of the thigh [see DOSAGE AND ADMINISTRATION and PATIENT INFORMATION].
Do not inject intravenously.
Do not inject into buttock.
Do not inject into digits, hands or feet.
Hold leg firmly during injection.
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject Adrenaclick into the buttock [see Injection-Related Complications]. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.
The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.
Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium bisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.
The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.
Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer Adrenaclick to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.
[see FDA-Approved Patient Labeling (PATIENT INFORMATION and Instructions for Use)]
A healthcare provider should review the patient instructions and operation of Adrenaclick, in detail, with the patient or caregiver.
Epinephrine is essential for the treatment of anaphylaxis. Carefully instruct patients who are at risk of or with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens, as well as idiopathic and exercise-induced anaphylaxis, about the circumstances under which epinephrine should be used.
Instruct patients and/or caregivers in the appropriate use of Adrenaclick. Adrenaclick should be injected into the middle of the outer thigh (through clothing if necessary).
Instruct caregivers to hold the leg of young children firmly in place and limit movement prior to and during injection. Lacerations, bent needles, and embedded needles have been reported when Adrenaclick has been injected into the thigh of young children who are uncooperative and kick during an injection [see WARNINGS AND PRECAUTIONS].
Each Adrenaclick is a single-use injection. Advise patients to seek immediate medical care in conjunction with administration of Adrenaclick.
Complete patient information, including dosage, directions for proper administration and precautions can be found inside each Adrenaclick carton. A printed label on the surface of Adrenaclick shows instructions for use and a diagram depicting the injection process.
Instruct patients and/or caregivers to use the Trainer to familiarize themselves with the use of Adrenaclick in an allergic emergency. The Trainer may be used multiple times.
Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These signs and symptoms usually subside rapidly, especially with rest, quiet, and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina. Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms [see WARNINGS AND PRECAUTIONS].
Advise patients to seek immediate medical care in the case of accidental injection. Since epinephrine is a strong vasoconstrictor when injected into the digits, hands or feet, treatment should be directed at vasodilation if there is such an accidental injection to these areas [see WARNINGS AND PRECAUTIONS].
Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site [see WARNINGS AND PRECAUTIONS].
Instruct patients to inspect the epinephrine solution visually through the viewing window periodically. Replace Adrenaclick if the epinephrine solution appears discolored (pinkish or brown), cloudy, or contains particles. Epinephrine is light sensitive, store in the outer case provided to protect it from light. Instruct patients that Adrenaclick must be properly disposed of once the blue caps have been removed or after use [see HOW SUPPLIED/Storage and Handling].
Complete patient information, including dosage, directions for proper administration and precautions are provided inside each Adrenaclick auto-injector carton.
Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted.
Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro and to be an oxidative mutagen in a WP2 bacterial reverse mutation assay.
Epinephrine was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenic in the Salmonella bacterial reverse mutation assay.
The potential for epinephrine to impair fertility has not been evaluated.
This should not prevent the use of epinephrine under the conditions noted under Indications and Usage (1).
Pregnancy Category C.
There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women.
Epinephrine was teratogenic in rabbits, mice and hamsters. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both).
Epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m² basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m² basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m² basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days).
These effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m² basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
It is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adrenaclick is administered to a nursing woman.
Adrenaclick may be administered to pediatric patients at a dosage appropriate to body weight [see DOSAGE AND ADMINISTRATION]. Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the dose of epinephrine delivered from Adrenaclick is fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, Adrenaclick should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see WARNINGS AND PRECAUTIONS and OVERDOSAGE].
Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of a rapidly acting vasodilators or alpha-adrenergic blocking drugs and/or respiratory support.
Epinephrine overdosage can also cause transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-adrenergic blocking drug such as propranolol.
Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis, and kidney failure. Suitable corrective measures must be taken in such situations.
None.
Epinephrine acts on both alpha-and beta-adrenergic receptors.
Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.
Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing, and dyspnea that may occur during anaphylaxis.
Epinephrine also alleviates pruritus, urticaria, and angioedema, and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.
When given intramuscularly or subcutaneously, epinephrine has a rapid onset and short duration of action.
ADRENACLICK®
(a-dren-a-click)
(epinephrine) Injection, USP Auto-Injector
Read this Patient Information Leaflet carefully before you use the Adrenaclick auto-injector, and each time you get a refill. There may be new information. You, your parent, caregiver, or others who may be in a position to administer Adrenaclick auto-injector should know how to use it 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 Adrenaclick?
1. Adrenaclick contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Symptoms of an anaphylaxis may include:
2. Always carry your Adrenaclick with you because you may not know when anaphylaxis may happen. Talk to your healthcare provider if you need additional units to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your Adrenaclick and how to use it before you need it. You may be unable to speak in an allergic emergency.
3. When you have an allergic emergency (anaphylaxis)
What is Adrenaclick?
What should I tell my healthcare provider before using Adrenaclick?
Before you use Adrenaclick, tell your healthcare provider about all your medical conditions, especially if you:
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.
Adrenaclick and other medicines may affect each other, causing side effects. Adrenaclick may affect the way other medicines work, and other medicines may affect how Adrenaclick works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Use your Adrenaclick auto-injector for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or the medicine you take.
How should I use Adrenaclick?
What are the possible side effects of Adrenaclick?
Adrenaclick may cause serious side effects.
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 Adrenaclick. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Adrenaclick?
Keep Adrenaclick and all medicines out of the reach of children.
General information about the safe and effective use of Adrenaclick:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Adrenaclick for a condition for which it was not prescribed. Do not give Adrenaclick to other people.
This Patient Information Leaflet summarizes the most important information about Adrenaclick. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Adrenaclick that is written for health professionals.
For more information and video instructions on the use of Adrenaclick, go to www.adrenaclick.com or call 1-888-894-6528.
What are the ingredients in Adrenaclick?
Active Ingredient: epinephrine
Inactive Ingredients: sodium chloride, chlorobutanol, sodium bisulfite, hydrochloric acid and sodium hydroxide, and water.
Important Information
Instructions for Use
ADRENACLICK®
(a-dren-a-click)
(epinephrine injection, USP) Auto-Injector For allergic
emergencies (anaphylaxis)
Read these Instructions for Use carefully before you use Adrenaclick. Before you need to use your Adrenaclick, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer Adrenaclick auto-injector should also understand how to use it well. If you have any questions, ask your healthcare provider.
Your Adrenaclick auto-injector
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STEP 1. Prepare Adrenaclick for injection
Note:
Figure A
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STEP 2. Administer Adrenaclick
Figure B
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STEP 3. Get emergency medical help right away. You may need further medical attention. You may need to use a second Adrenaclick auto-injector if symptoms continue or recur.
STEP 4. After use / Disposal
Carefully cover the needle with the carrying case.
Figure C
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Figure D
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Note:
For more information and video instructions on the use of Adrenaclick, go to www.adrenaclick.com or call 1-888-894-6528.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
