Anaphylaxis is a sudden, potentially severe allergic reaction

What Is Anaphylaxis?

Anaphylaxis is an acute, potentially life-threatening allergic reaction that is rapid in onset, and may result in respiratory compromise, cardiovascular collapse, and death.^1,2,3 Reactions are most commonly caused by allergies to food such as peanuts and seafood, drugs like penicillin and aspirin, and insect stings from bees or wasps.^1,4

Common Causes of Anaphylaxis

Food allergies (caused by peanuts, tree nuts, fish, shellfish, milk, eggs)¹

Food allergies account for 35% to 55% of all cases of anaphylaxis

Insect stings (often associated with bees, wasps, hornets)⁴

At least 40 people die each year in the United States as a result of insect stings
Estimated that potentially life-threatening systemic reactions to insect stings occur in 0.4% to 0.8% of children and 3% of adults

Drug allergies (caused by penicillin, aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs])¹

Penicillin is the most common cause of drug-induced anaphylaxis

Latex allergies (caused by gloves, catheters, adhesives, tourniquets, and anesthesia equipment)¹

Higher risk groups include health care workers, children with spina bifida and genitourinary abnormalities, and workers with occupational exposure to latex

Exercise (associated factors include aspirin, NSAIDs, food ingestion before or after exercise)¹

Patients with exercise-induced anaphylaxis should carry epinephrine and MedicAlert^® identification of their condition

Symptoms of Anaphylaxis

The signs and symptoms of anaphylaxis may begin within seconds to minutes of exposure to or contact with an offending stimulus, but in certain situations symptoms may develop more than 30 minutes after exposure.^1,5

Patterns of Anaphylactic Reactions

An isolated anaphylactic reaction is referred to as a uniphasic reaction.⁵ Biphasic reactions often occur 8 to 12 hours after the immediate reaction. Biphasic reactions can occur up to 72 hours after resolution of initial reactions; a need for a second dose cannot be predicted.² Some protracted reactions can last up to 32 hours, despite aggressive treatment.¹

Symptoms of anaphylaxis may include any of the following¹:

Swelling in the mouth and throat
A rash anywhere on the body and appearance of flushed skin
Difficulty swallowing or speaking
Difficulty breathing
Abdominal cramps
Nausea, vomiting, diarrhea
Feeling of “impending doom”
Lightheadedness
Headache
Menstrual cramps
Collapse and unconsciousness

Emergency Treatments for Anaphylaxis

Epinephrine and oxygen are the most important therapeutic agents to be administered during an anaphylactic reaction.¹ Immediate recognition of the signs and symptoms of anaphylaxis is crucial.

Twinject Auto-Injector (Epinephrine)

The appropriate dose of Epinephrine should be given promptly at the onset of apparent anaphylaxis.¹ If a patient has previously had an anaphylactic reaction, he or she may already be carrying an auto-injector.² Twinject auto-injectors contain 2 doses of epinephrine. One dose is for a uniphasic (occurring immediately) reaction. The next step is to call 911 to ensure emergency services are on the way. The second dose is to be administered for an acute reaction in which a single dose is not enough to reverse symptoms, or to be used in the event of a biphasic or protracted reaction.

Twinject auto-injectors also are available in 2 dosing strengths. The Twinject 0.15 mg is for those weighing between 33 and 66 pounds (approximately 15 to 30 kilograms) and the Twinject 0.3 mg is for those who weigh 66 pounds (approximately 30 kilograms) or more.

Twinject also may be prescribed as a Two-Pack, which includes 2 Twinject auto-injectors and a demonstrator. Storing Twinject auto-injectors in multiple locations helps ensure that protection is always within reach—at school, at home, and on the go.

Click here for Twinject administration instructions.

Once emergency treatment has been administered, it is important to seek immediate medical attention.

INDICATION:

Twinject (epinephrine injection, USP 1:1000) is indicated in the emergency treatment of severe 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 anaphylaxis to unknown substancess (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Twinject is intended for immediate administration in patients with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (See DOSAGE AND ADMINISTRATION section). Such 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. Twinject is designed as emergency supportive therapy only and is not a replacement or substitute for immediate medical care.

IMPORTANT SAFETY INFORMATION ABOUT TWINJECT:

Twinject should only be injected into the anterolateral aspect of the thigh. Accidental injection into the hands or feet may result in loss of blood flow to the affected area and should be avoided.

If there is an accidental injection into these areas, advise the patient to inform the healthcare provider of the accidental injection when he/she goes to the nearest emergency room for further treatment of anaphylaxis. Avoid possible inadvertent intravascular administration. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to a sharp rise in blood pressure. DO NOT INJECT INTRAVENOUSLY. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.

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. 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 should be administered with caution to patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In patients with coronary insufficiency or ischemic heart disease, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute life-threatening situation.

Epinephrine is light sensitive and should be stored in the carrying-case provided. Store at room temperature (20°-25°C/68°-77°F) with excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate; protect from freezing. Patients should periodically check the solution in Twinject for any discoloration and/or precipitates. If the solution is discolored or contains a precipitate, the patient should replace their Twinject.

Twinject is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek appropriate medical care. More than two sequential doses of epinephrine should only be under direct medical supervision. Twinject is not suitable for patients, or caregivers, with such disabilities as severe debilitating arthritis of the hands, because the use of this product requires some manual dexterity to administer. IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THE PATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF Twinject.

Epinephrine is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions should be instructed about the circumstances under which epinephrine should be used. It should be determined that the patient is at risk of future anaphylaxis, since there are some concerns in specific patients with epinephrine administration. (a) Epinephrine should be used with caution in patients with cardiac arrhythmias, coronary artery or organic heart disease, hypertension, or in patients who are on medications that may sensitize the heart to arrhythmias, e.g., digitalis, diuretics, or anti-arrhythmics. In such patients, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. (b) The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors. (c) Some patients may be at greater risk of developing adverse reactions after epinephrine administration. These include patients with hyperthyroidism, cardiovascular disease, hypertension, diabetes, and elderly individuals, and pregnant women. It must be noted that, despite these concerns, epinephrine is essential for the treatment of anaphylaxis. Therefore, patients with these conditions, or any other person who might be in a position to administer epinephrine to a patient with these conditions experiencing anaphylaxis, should be instructed about the circumstances under which epinephrine should be used.

Drug Interactions

Patients who receive epinephrine while concomitantly taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, sodiumlevothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine. The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol. The vasoconstricting and hypertensive efffects are antagonized by alpha-adrenergic blocking drugs, such as phentolamine. Ergot alkaloids and phenothiazines may also reverse the pressor effects of epinephrine.

Pregnancy

Pregnancy Category C. Epinephrine has been shown to have developmental effects in rabbits at a subcutaneous dose of 1.2 mg/kg (approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis), in mice at a subcutaneous dose of 1 mg/kg (approximately 7 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis), and in hamsters at a subcutaneous dose of 0.5 mg/kg (approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). These effects were not seen in mice at a subcutaneous dose of 0.5 mg/kg (approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). Although there are no adequate and well-controlled studies in pregnant women, epinephrine crosses the placenta and could lead to fetal anoxia, spontaneous abortion or both. Therefore, epinephrine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Since the doses of epinephrine delivered from Twinject are fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from Twinject are felt to be necessary (e.g., patients who weigh less than 15 kilograms approximately 33 pounds). IN ALL CASES, THE PHYSICIAN SHOULD INSTRUCT THE PATIENT AND/OR ANY OTHER PERSON WHO MIGHT BE IN A POSITION TO ADMINISTER THE EPINEPHRINE, IN THE PROPER USE OF TWINJECT.

ADVERSE REACTIONS

Adverse reactions to epinephrine include transient, moderate 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. Large doses of epinephrine can cause acute hypertension. Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see (3) Drug Interactions]. Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease. The potential for epinephrine to produce these types of adverse reactions does not contraindicate its use in an acute, life-threatening allergic reaction.

Twinject is a patient (or caregiver) actuated, dual-dose product that contains 1.1 mL of epinephrine injection, USP (1:1000 or 1 mg/mL), of which an initial dose can be delivered by auto-injection, and a second dose is available by manual administration. THE REMAINING VOLUME THAT IS LEFT AFTER THESE TWO FIXED DOSES CANNOT BE FURTHER ADMINISTERED AND SHOULD BE DISCARDED WITH THE DEVICE AS OUTLINED IN THE PATIENT INFORMATION LEAFLET.

Please see complete prescribing information for more details.

Your doctor can give you more information about Twinject or call 1-888-894-6528. Ask your doctor if Twinject may be right for you.

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

This web site and its contents are intended for use only by residents of the United States. Products discussed may have different labeling, regulatory requirements, and/or medical practices in other countries that may require reference to different or additional information.

Video Player Data