Sciele Introduces Adrenaclick™ (epinephrine injection, USP) Auto-Injector for the Emergency Treatment of Anaphylaxis

ATLANTA--(BUSINESS WIRE)--Sciele Pharma, Inc., a Shionogi company, today announced the U.S. availability of Adrenaclick™, a single-dose, epinephrine auto-injector for the emergency treatment for severe allergic reactions (Type I) such as anaphylaxis. Adrenaclick™ will be available as a single unit or a convenient Two-Pack. It is also available in two dosing options (0.15 mg and 0.3 mg).

Adrenaclick™ delivers epinephrine, the drug of choice for anaphylactic reactions, with the use of an auto-injector. The Adrenaclick™ auto-injector is designed to ensure accurate delivery of epinephrine in the thigh through a “press-and-hold” administration technique. It is also designed for ease-of-use with clearly labeled caps, a red injector tip, and color-coded instructions on the side of the unit. Sciele is also offering free training information to help educate patients on the proper administration; full details are available online at www.adrenaclick.com.

Indication

Adrenaclick™ is indicated for the emergency treatment of severe allergic reactions (Type I) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances, and other allergens, as well as anaphylaxis to unknown substances or exercise-induced anaphylaxis.

Important Safety Information About Adrenaclick™

Adrenaclick™ 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. DO NOT INJECT INTO BUTTOCK. DO NOT INJECT INTRAVENOUSLY.

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.

Adverse reactions to epinephrine include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties.

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, sodium levothyroxine, and certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine.

Adrenaclick™ is designed as an emergency supportive therapy only and is not a replacement or substitute for immediate medical care. Since the dose of epinephrine delivered from Adrenaclick™ is fixed, the physician should consider other forms of injectable epinephrine if doses lower than those available from Adrenaclick™ are felt to be necessary (e.g., patients who weigh less than 15 kilograms, approximately 33 pounds). Full prescribing information for Adrenaclick is at www.adrenaclick.com.

About Sciele Pharma, Inc.

Sciele Pharma, Inc., an indirect wholly owned subsidiary of Shionogi & Co., Ltd, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women’s Health and Pediatrics. The Company’s Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and type 2 diabetes. Its Women’s Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, head lice, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele employs approximately 900 people. The Company’s success is based on placing the needs of patients first and improving health and quality of life.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd., headquartered in Osaka, Japan, is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of people who need them. In addition, Shionogi is engaged in some new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi’s primary goal. For more details, please visit www.shionogi.co.jp.