BYETTA- exenatide injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Physicians Total Care, Inc.

INN (nemzetközi neve):

exenatide

Összetétel:

exenatide 250 ug in 1 mL

Az alkalmazás módja:

SUBCUTANEOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. BYETTA is not a substitute for insulin. BYETTA should not be used for the treatment of type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of BYETTA with prandial insulin has not been studied and cannot be recommended. Based on postmarketing data BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. BYETTA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using BYETTA. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. BYETTA is contraindicated in patients with prior severe hypersensitivity reactions to exenatide or to any of the product components. Pregnancy Category C There are no adequate and well-c

Termék összefoglaló:

BYETTA is supplied as a sterile solution for subcutaneous injection containing 250 mcg/mL exenatide. The following packages are available: 5 mcg per dose, 60 doses, 1.2 mL prefilled pen, NDC 54868-5384-0 10 mcg per dose, 60 doses, 2.4 mL prefilled pen, NDC 54868-5384-1

Engedélyezési státusz:

New Drug Application

Betegtájékoztató

BYETTA - EXENATIDE INJECTION
Physicians Total Care, Inc.
----------
Medication Guide
BYETTA® (bye-A-tuh)
(exenatide)
Injection
Read this Medication Guide and the Pen User Manual that come with
BYETTA before you start using it
and each time you get a refill. There may be new information. This
Medication Guide does not take the
place of talking with your healthcare provider about your medical
condition or your treatment. If you
have questions about BYETTA after reading this information, ask your
healthcare provider or pharmacist.
What is the most important information I should know about BYETTA?
Serious side effects can happen in people who take BYETTA, including
inflammation of the pancreas
(pancreatitis) which may be severe and lead to death.
Before taking BYETTA, tell your healthcare provider if you have had:
•
pancreatitis.
•
stones in your gallbladder (gallstones).
•
a history of alcoholism.
•
high blood triglyceride levels.
These medical conditions can make you more likely to get pancreatitis
in general. It is not known if
having these conditions will lead to a higher chance of getting
pancreatitis while taking BYETTA.
While taking BYETTA:
Call your healthcare provider right away if you have pain in your
stomach area (abdomen) that is severe,
and will not go away. The pain may happen with or without vomiting.
The pain may be felt going from
your abdomen through to your back. These may be symptoms of
pancreatitis.
What is BYETTA?
•
BYETTA is an injectable prescription medicine that may improve blood
sugar (glucose) control in
adults with type 2 diabetes mellitus, when used with a diet and
exercise program.
•
BYETTA is not insulin.
•
You should not take BYETTA instead of insulin.
•
The use of BYETTA with short acting insulin is not recommended.
•
The use of BYETTA with rapid acting insulin is not recommended.
•
BYETTA is not for people with type 1 diabetes or people with diabetic
ketoacidosis.
•
It is not known if BYETTA is safe and effective in children.
•
BYETTA has not been studied i

Termékjellemzők

BYETTA - EXENATIDE INJECTION
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BYETTA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BYETTA.
BYETTA (EXENATIDE) INJECTION
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
10/2011
Warnings and Precautions, Use with Medications Known to Cause
Hypoglycemia
(5.2)
10/2011
INDICATIONS AND USAGE
BYETTA 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.
IMPORTANT LIMITATIONS OF USE
Not a substitute for insulin. BYETTA should not be used for the
treatment of type 1 diabetes or diabetic ketoacidosis
(1.2).
Concurrent use with prandial insulin has not been studied and cannot
be 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).
DOSAGE AND ADMINISTRATION
Inject subcutaneously within 60 minutes prior to morning and evening
meals (or before the two main meals of the day,
approximately 6 hours or more apart) (2.1).
Initiate at 5 mcg per dose twice daily; increase to 10 mcg twice daily
after 1 month based on clinical response (2.1).
DOSAGE FORMS AND STRENGTHS
BYETTA is supplied as 250 mcg/mL exenatide in: (3)
5 mcg per dose, 60 doses, 1.2 mL prefilled pen
10 mcg per dose, 60 doses, 2.4 mL prefilled pen
CONTRAINDICATIONS
History of severe hypersensitivity to exenatide or any product
components (4.1).
WARNINGS AND PRECAUTIONS
Pancreatitis: Postmarketing reports with exenatide, including fatal
and non-fatal hemorrhagic or necrotizing pancreatitis.
_Discontinue BYETTA promptly. BYETTA should not be restarted.
_Consider other antidiabetic therapies in patients with a
history of pancreatitis (5.1).
Hypoglycemia: Increased risk when BYETTA is used in combination with
medications known to cause hypoglycemia
(e.g. insuli