BYDUREON exenatide

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

exenatide (UNII: 9P1872D4OL) (exenatide - UNII:9P1872D4OL)

Dostupno od:

Amylin Pharmaceuticals, LLC

INN (International ime):

exenatide

Sastav:

exenatide 2 mg in 0.65 mL

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

New Drug Application

Svojstava lijeka

BYDUREON- EXENATIDE
AMYLIN PHARMACEUTICALS, LLC
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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._
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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
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
BYDUREON 2 mg exenatide for extended-release injectable suspension has
two dosage forms (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
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