BYDUREON- exenatide injection, suspension, extended release BYDUREON- exenatide kit

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

EXENATIDE (UNII: 9P1872D4OL) (EXENATIDE - UNII:9P1872D4OL)

Доступна с:

AstraZeneca Pharmaceuticals LP

ИНН (Международная Имя):

EXENATIDE

состав:

EXENATIDE 2 mg in 0.65 mL

Администрация маршрут:

SUBCUTANEOUS

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus [see Clinical Studies (14)]. Limitations of Use : BYDUREON is contraindicated in patients with: Limited data with exenatide, the active ingredient in BYDUREON, in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations) . Based on animal reproduction studies, there may be risks to the fetus from exposure to BYDUREON during pregnancy. BYDUREON should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies identified increased adverse fetal and neonatal outcomes from exposure to exenatide extended-release during pregnancy, or from exposure to exenatide, during pregnancy and lactation, in associatio

Обзор продуктов:

How supplied BYDUREON (exenatide) for extended-release injectable suspension is supplied as: Do not substitute needles or any other components provided with BYDUREON. Storage and Handling

Статус Авторизация:

New Drug Application

тонкая брошюра

BYDUREON- EXENATIDE
AstraZeneca Pharmaceuticals LP
----------
MEDICATION GUIDE
BYDUREON® (by-DUR-ee-on)
(exenatide)
for extended-release injectable suspension, for subcutaneous use
What is the most important information I should know about BYDUREON?
BYDUREON may cause serious side effects, including:
•
Possible thyroid tumors, including cancer. Tell your healthcare
provider if you get a lump or
swelling in your neck, hoarseness, trouble swallowing, or shortness of
breath. These may be
symptoms of thyroid cancer. In studies with rats or mice, BYDUREON and
medicines that work
like BYDUREON caused thyroid tumors, including thyroid cancer. It is
not known if BYDUREON
will cause thyroid tumors or a type of thyroid cancer called medullary
thyroid carcinoma (MTC) in
people.
•
Do not use BYDUREON if you or any of your family have ever had a type
of thyroid cancer called
medullary thyroid carcinoma (MTC), or if you have an endocrine system
condition called Multiple
Endocrine Neoplasia syndrome type 2 (MEN 2).
What is BYDUREON?
•
BYDUREON is an injectable prescription medicine that may improve blood
sugar (glucose) in
adults and children who are 10 years of age and older with type 2
diabetes mellitus and should be
used along with diet and exercise.
•
BYDUREON is not recommended as the first choice of medicine for
treating diabetes.
•
BYDUREON is not for use in people with type 1 diabetes.
•
BYDUREON and BYDUREON BCise are long-acting forms of the medicine in
BYETTA
(exenatide). BYDUREON should not be used at the same time as BYETTA or
BYDUREON
BCise.
•
It is not known if BYDUREON can be used in people who have had
pancreatitis.
•
It is not known if BYDUREON is safe and effective for use in children
younger than 10 years of
age.
Who should not use BYDUREON?
Do not use BYDUREON if:
•
you or any of your family have ever had a type of thyroid cancer
called medullary thyroid
carcinoma (MTC) or if you have an endocrine system condition called
Multiple Endocrine
Neoplasia syndrome type 2 (MEN 2).
•
you have h

Характеристики продукта

BYDUREON- EXENATIDE INJECTION, SUSPENSION, EXTENDED RELEASE
BYDUREON- EXENATIDE
ASTRAZENECA PHARMACEUTICALS LP
----------
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) FOR EXTENDED-RELEASE INJECTABLE SUSPENSION, FOR
SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2005
WARNING: RISK OF THYROID C-CELL TUMORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions, Acute Gallbladder Disease
(5.10) 06/2022
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 and pediatric patients
aged 10 years and older with type 2
diabetes mellitus. (1)
Limitations of Use:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
For extended-release injectable suspension available as: (3)
•
•
CONTRAINDICATIONS
•
•
•
®
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 THE HUMAN
RELEVANCE OF
EXENATIDE EXTENDED-RELEASE-INDUCED RODENT THYROID C-CELL TUMORS HAS
NOT BEEN
DETERMINED (5.1, 13.1).
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). COUNSEL
PATIENTS REGARDING THE POTENTIAL RISK OF MTC AND THE SYMPTOMS OF
THYROID TUMORS
(4, 5.1).
Not recommended as first-line therapy for patients inadequately
controlled on diet and exercise. (1)
Should not be used to treat type 1 diabetes. (1)
BYDUREON is an extended-release formulation of exenatide. Do not
coadminister with other
exenatide-containing products. (1)
Has not been studied in patients with a history of pancreatitis.
Consider other antidiabetic therapies in
patient