TANZEUM- albiglutide injection, powder, lyophilized, for solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

ALBIGLUTIDE (UNII: 5E7U48495E) (ALBIGLUTIDE - UNII:5E7U48495E)

Saadav alates:

GlaxoSmithKline LLC

INN (Rahvusvaheline Nimetus):

ALBIGLUTIDE

Koostis:

ALBIGLUTIDE 30 mg in 0.5 mL

Manustamisviis:

SUBCUTANEOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

TANZEUM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14)]. Limitations of Use: TANZEUM is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)] . TANZEUM is contraindicated in patients with a prior serious hypersensitivity reaction to albiglutide or to any of the product components. Serious hypersensitivity reactions including angioedema have been reported with TANZEUM [see Warnings and Precautions (5.4)]. Pregnancy Category C There are no adequate and well-controlled studies of TANZEUM in pregnant women. Nonclinical studies have shown reproductive toxicity, but not teratogenicity, in mice treated with albiglutide at up to 39 times human exposure resulting from the maximum recommended dose of 50 mg/week, based on AUC [see Nonclinical Toxicology (13.1, 13.3)]. TAN

Toote kokkuvõte:

TANZEUM is available in the following strengths and package size: 30-mg single-dose Pen (NDC 0173-0866-01): 50-mg single-dose Pen (NDC 0173-0867-01):

Volitamisolek:

Biologic Licensing Application

Infovoldik

GlaxoSmithKline LLC
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Medication Guide
TANZEUM (TAN-zee-um)
(albiglutide)
for injection, for subcutaneous use
Read this Medication Guide before you start using TANZEUM and each
time you get a refill. There may
be new information. This information does not take the place of
talking to your healthcare provider about
your medical condition or your treatment.
What is the most important information I should know about TANZEUM?
TANZEUM 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 and mice, medicines
that work like TANZEUM
caused thyroid tumors, including thyroid cancer. It is not known if
TANZEUM will cause thyroid
tumors or a type of thyroid cancer called medullary thyroid carcinoma
(MTC) in people.
•
Do not use TANZEUM 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 TANZEUM?
TANZEUM is an injectable prescription medicine that may improve blood
sugar (glucose) in adults with
type 2 diabetes mellitus, and should be used along with diet and
exercise.
•
TANZEUM is not recommended as the first choice of medicine for
treating diabetes.
•
It is not known if TANZEUM can be used in people who have had
pancreatitis.
•
TANZEUM is not a substitute for insulin and is not for use in people
with type 1 diabetes or people
with diabetic ketoacidosis.
•
TANZEUM is not recommended for use in people with severe stomach or
intestinal problems.
•
It is not known if TANZEUM can be used with mealtime insulin.
•
It is not known if TANZEUM is safe and effective for use in children
under 18 years of age.
Who should not use TANZEUM?
Do not use TANZEUM if:
•
you or any of your family have ever had a type of thyroid c

Toote omadused

TANZEUM- ALBIGLUTIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
GLAXOSMITHKLINE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TANZEUM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TANZEUM.
TANZEUM (ALBIGLUTIDE) FOR INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2014
WARNING: RISK OF THYROID C-CELL TUMORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Contraindications (4)
8/2017
Warnings and Precautions (5.4)
8/2017
Warnings and Precautions, Acute Kidney Injury (5.5)
12/2017
INDICATIONS AND USAGE
TANZEUM is a GLP-1 receptor agonist indicated as an adjunct to diet
and exercise to improve glycemic control in adults
with type 2 diabetes mellitus. (1)
Limitations of Use:
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
For injection: 30 mg or 50 mg in a single-dose Pen. (3)
CONTRAINDICATIONS
•
•
CARCINOGENICITY OF ALBIGLUTIDE COULD NOT BE ASSESSED IN RODENTS, BUT
OTHER GLUCAGON-LIKE PEPTIDE-1
(GLP-1) RECEPTOR AGONISTS HAVE CAUSED THYROID C-CELL TUMORS IN RODENTS
AT CLINICALLY RELEVANT
EXPOSURES. HUMAN RELEVANCE OF GLP-1 RECEPTOR-AGONIST-INDUCED C-CELL
TUMORS IN RODENTS HAS NOT
BEEN DETERMINED. IT IS UNKNOWN WHETHER TANZEUM CAUSES THYROID C-CELL
TUMORS, INCLUDING
MEDULLARY THYROID CARCINOMA (MTC), IN HUMANS. (5.1, 13.1)
TANZEUM 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 SYMPTOMS OF THYROID TUMORS. (4.1, 5.1)
Not recommended as first-line therapy for patients inadequately
controlled on diet and exercise. (1, 5.1)
Has not been studied in patients with a history of pancreatitis.
Consider other antidiabetic therapies in patients with a
history of pancreatitis. (1, 5.2)
Not for treatment of type 1 diabetes mellitus or diabetic
ketoacidosis. (1)
Not for patients with pre-existing