Twinject Auto-Injector

Available as:    0.3 mg    0.15 mg

each dose delivers 0.15 mg or 0.3 mg of epinephrine

PRESCRIBING INFORMATION

Epinephrine is the drug of choice for the emergency treatment of severe allergic reactions (Type I) to allergens, such as those present in certain insect venoms, foods, or drugs. It can also be used in the treatment of anaphylaxis of unknown cause (idiopathic anaphylaxis) or exercise-induced anaphylaxis. Epinephrine, when given intramuscularly or subcutaneously, has a rapid onset and short duration of action. 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 an anaphylactic reaction and can lead to loss of intravascular fluid volume and hypotension. Through its action on beta adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation that helps alleviate bronchospasm, wheezing, and dyspnea that may occur during anaphylaxis. Epinephrine also helps alleviate pruritus, urticaria, and angioedema, and may be effective in relieving gastrointestinal and genitourinary symptoms of anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder.

(1) General

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 administered 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 (See INDICATIONS AND USAGE Section). 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.

(2) Information for Patients

Complete patient information, including dosage, directions for proper administration, and precautions, can be found inside each Twinject package within the Patient Information Leaflet.

Epinephrine may produce symptoms and signs that include an increase in pulse rate, the sensation of a more forceful heartbeat, palpitations, a throbbing headache, pallor, feelings of overstimulation, anxiety, weakness, shakiness, dizziness, or nausea. 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.

(3) 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, sodium levothyroxine, 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.

(4) Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no data from either animal or human studies regarding the carcinogenicity or mutagenicity of epinephrine, and no studies have been conducted to determine its potential for the impairment of fertility. This should not prevent the use of epinephrine under the conditions noted under INDICATIONS AND USAGE section.

(5) Pregnancy

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.

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.

Twinject 0.15 mg is available in a single unit carton, NDC 59630-801-01, and in a Two-Pack, NDC 59630-801-02, containing two Twinject 0.15 mg auto-injectors and one Twinject Demonstrator.

Twinject 0.3 mg is available in a single unit carton, NDC 59630-802-01, and in a Two-Pack, NDC 59630-802-02, containing two Twinject 0.3 mg auto-injectors and one Twinject Demonstrator.

PROTECT FROM LIGHT. STORE AT ROOM TEMPERATURE, 20°-25°C (68°-77°F) WITH EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F). PROTECT FROM FREEZING. DO NOT REFRIGERATE.

Rx only.

Manufactured for and Distributed by: Shionogi Pharma, Inc., Atlanta, GA 30328

©2010 Shionogi Pharma, Inc., Atlanta, GA. All rights reserved. This product may be covered by some or all of the following patents, patent applications and foreign equivalents thereof: U.S. Patent Nos. 5,358,489; 5,540,664; 5,665,071; and 7,297,136 and other pending U.S. Patent applications.

Printed in USA
Revised January, 2010

For inquiries call 1-888-TWIN-JCT

Rx Only
Contains One Twinject® 0.15mg Auto-Injector
NDC 59630-801-01

Two doses in each
Twinject® auto-injector

For Subcutaneous or
Intramuscular Use Only

Twinject®
auto-injector
(epinephrine injection, USP 1:1000)
each dose delivers 0.15 mg of epinephrine

Manufactured for and Distributed by:
Shionogi Pharma, Inc.
Atlanta, GA 30328 USA

SHIONOGI PHARMA, INC.

For Allergic Emergencies (Anaphylaxis)
Patient Reminder Program, See Details Inside