艾塞那肽缓释制剂说明书.pdf

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 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 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 in multiple clinical settings 1 1 14 BYDUREON is an extended release formulation of exenatide Do not co administer with BYETTA Important Limitations of Use Not recommended as first line therapy for patients inadequately controlled on diet and exercise 5 1 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 DOSAGE AND ADMINISTRATION Administer 2 mg by subcutaneous injection once every seven days weekly at any time of day and with or without meals 2 1 Administer immediately after the powder is suspended 2 1 DOSAGE FORMS AND STRENGTHS BYDUREON is 2 mg exenatide for extended release injectable suspension CONTRAINDICATIONS Do not use if personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 4 1 Do not use if history of serious hypersensitivity to exenatide or any product components 4 2 FULL PRESCRIBING INFORMATION CONTENTS 1 INDICATIONS AND USAGE 1 1 Type 2 Diabetes Mellitus 1 2 Important Limitations of Use 2 DOSAGE AND ADMINISTRATION 2 1 Recommended Dosing 2 2 Administration 2 3 Changing from BYETTA to BYDUREON 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 4 1 Medullary Thyroid Carcinoma 4 2 Hypersensitivity 5 WARNINGS AND PRECAUTIONS 5 1 Risk of Thyroid C cell Tumors 5 2 Acute Pancreatitis 5 3 Hypoglycemia 5 4 Renal Impairment 5 5 Gastrointestinal Disease 5 6 Immunogenicity 5 7 Hypersensitivity 5 8 Macrovascular Outcomes 6 ADVERSE REACTIONS 6 1 Clinical Trial Experience 6 2 Post Marketing Experience 7 DRUG INTERACTIONS 7 1 Orally Administered Drugs 7 2 Warfarin 8 USE IN SPECIFIC POPULATIONS 8 1 Pregnancy 8 3 Nursing Mothers 8 4 Pediatric Use 8 5 Geriatric Use 8 6 Renal Impairment 8 7 Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION WARNINGS AND PRECAUTIONS Thyroid C cell tumors in animals Human relevance unknown Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors 5 1 Pancreatitis Postmarketing reports with exenatide including fatal and non fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if pancreatitis is confirmed Consider other antidiabetic therapies if history of pancreatitis 5 2 Hypoglycemia Increased risk when BYDUREON is used in combination with a sulfonylurea Consider reducing the sulfonylurea dose 5 3 Renal Impairment Postmarketing reports with exenatide sometimes requiring hemodialysis and kidney transplantation Not recommended if severe renal impairment or end stage renal disease Use with caution in patients with renal transplantationor moderate renal impairment 5 4 8 6 12 3 Severe Gastrointestinal Disease Not recommended if severe gastrointestinal disease e g gastroparesis 5 5 Hypersensitivity Postmarketing reports with exenatide of serious hypersensitivity reactions e g anaphylaxis and angioedema In such cases patients are to discontinue BYDUREON and other suspect medications and promptly seek medical advice 5 7 Macrovascular outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with BYDUREON or any other antidiabetic drug 5 8 ADVERSE REACTIONS Most common 5 and occurring more frequently than comparator in clinical trials nausea diarrhea headache vomiting constipation injection site pruritus injection site nodule and dyspepsia 5 3 6 1 To report SUSPECTED ADVERSE REACTIONS contact Amylin Pharmaceuticals Inc at 1 877 700 7365 and or FDA at 1 800 FDA 1088 or www fda gov medwatch DRUG INTERACTIONS May impact absorption of orally administered medications 7 1 12 3 Warfarin Postmarketing reports with exenatide of increased INR sometimes associated with bleeding Monitor INR frequently until stable upon initiation of BYDUREON therapy 7 2 6 2 USE 。