Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
exenatide (UNII: 9P1872D4OL) (exenatide - UNII:9P1872D4OL)
Amylin Pharmaceuticals, LLC
exenatide
exenatide 2 mg in 0.65 mL
PRESCRIPTION DRUG
New Drug Application
BYDUREON- EXENATIDE AMYLIN PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BYDUREON SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BYDUREON. BYDUREON (EXENATIDE EXTENDED-RELEASE FOR INJECTABLE SUSPENSION) INITIAL U.S. APPROVAL: 2012 WARNING: RISK OF THYROID C-CELL TUMORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • RECENT MAJOR CHANGES Warnings and Precautions, Injection-Site Reactions (5.8) 5/2014 INDICATIONS AND USAGE BYDUREON is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1.1, 14). BYDUREON is an extended-release formulation of exenatide. Do not coadminister with BYETTA. IMPORTANT LIMITATIONS OF USE • • • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS BYDUREON 2 mg exenatide for extended-release injectable suspension has two dosage forms (3): • • CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • ® EXENATIDE EXTENDED-RELEASE CAUSES THYROID C-CELL TUMORS AT CLINICALLY RELEVANT EXPOSURES IN RATS. IT IS UNKNOWN WHETHER BYDUREON CAUSES THYROID C-CELL TUMORS, INCLUDING MEDULLARY THYROID CARCINOMA (MTC), IN HUMANS, AS HUMAN RELEVANCE COULD NOT BE DETERMINED BY CLINICAL OR NONCLINICAL STUDIES (5.1). BYDUREON IS CONTRAINDICATED IN PATIENTS WITH A PERSONAL OR FAMILY HISTORY OF MTC OR IN PATIENTS WITH MULTIPLE ENDOCRINE NEOPLASIA SYNDROME TYPE 2 (MEN 2) (5.1). Not recommended as first-line therapy for patients inadequately controlled on diet and exercise (1.2). Should not be used to treat type 1 diabetes or diabetic ketoacidosis (1.2). Use with insulin has not been studied and is not recommended (1.2). Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis (1.2, 5.2). Administer 2 mg by subcutaneous injection once every seven days (weekly), at any time o Soma hati kamili