TRULICITY- dulaglutide injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DULAGLUTIDE (UNII: WTT295HSY5) (DULAGLUTIDE - UNII:WTT295HSY5)

Available from:

A-S Medication Solutions

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

TRULICITY® is indicated: - As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. - To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. Limitations of Use TRULICITY: - Has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)] . Consider other antidiabetic therapies in patients with a history of pancreatitis. - Should not be used in patients with type 1 diabetes mellitus. - Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see Warnings and Precautions (5.6)] . TRULICITY is contraindicated in patients with: - Personal or family history of medullary thyroid carcino

Product summary:

Product: 50090-6456 NDC: 50090-6456-0 .5 mL in a SYRINGE / 4 in a CARTON

Authorization status:

Biologic Licensing Application

Patient Information leaflet

A-S Medication Solutions
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration Revised:
November 2022
TRU-0009-MG-20221117
Medication Guide
TRULICITY® (TRU-li-si-tee)
(dulaglutide)
injection, for subcutaneous use
Read this Medication Guide before you start using TRULICITY 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 TRULICITY?
TRULICITY 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, TRULICITY
and medicines that work
like TRULICITY caused thyroid tumors, including thyroid cancer. It is
not known if
TRULICITY will cause thyroid tumors or a type of thyroid cancer called
medullary thyroid
carcinoma (MTC) in people.
•
Do not use TRULICITY 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 TRULICITY?
•
TRULICITY is an injectable prescription medicine that is used:
•
along with diet and exercise to improve blood sugar (glucose) in
adults and children 10
years of age and older with type 2 diabetes mellitus.
•
to reduce the risk of major cardiovascular events such as death, heart
attack, or stroke in
adults with type 2 diabetes mellitus with known heart disease or
multiple cardiovascular
risk factors.
•
It is not known if TRULICITY can be used in people who have had
pancreatitis.
•
TRULICITY is not for use in people with type 1 diabetes.
•
TRULICITY is not recommended for use in people with severe stomach or
intestinal problems.
•
It is not known if TRULICITY

Summary of Product characteristics

TRULICITY- DULAGLUTIDE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRULICITY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRULICITY.
TRULICITY (DULAGLUTIDE) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2014
WARNING: RISK OF THYROID C-CELL TUMORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
DULAGLUTIDE CAUSES THYROID C-CELL TUMORS IN RATS. IT IS UNKNOWN
WHETHER TRULICITY
CAUSES THYROID C-CELL TUMORS, INCLUDING MEDULLARY THYROID CARCINOMA
(MTC), IN
HUMANS AS THE HUMAN RELEVANCE OF DULAGLUTIDE-INDUCED RODENT THYROID
C-CELL TUMORS
HAS NOT BEEN DETERMINED (5.1, 13.1).
TRULICITY IS CONTRAINDICATED IN PATIENTS WITH A PERSONAL OR FAMILY
HISTORY OF MTC AND
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,
5.1).
RECENT MAJOR CHANGES
Indications and Usage (1)
11/2022
Dosage and Administration (2.2)
11/2022
Warnings and Precautions (5.8)
6/2022
INDICATIONS AND USAGE
TRULICITY is a glucagon-like peptide-1 (GLP-1) receptor agonist
indicated (1):
As an adjunct to diet and exercise to improve glycemic control in
adults and pediatric patients 10 years
of age and older with type 2 diabetes mellitus.
To reduce the risk of major adverse cardiovascular events in adults
with type 2 diabetes mellitus who
have established cardiovascular disease or multiple cardiovascular
risk factors.
Limitations of Use:
Has not been studied in patients with a history of pancreatitis.
Consider other antidiabetic therapies in
these patients (1, 5.2).
Not for treatment of type 1 diabetes mellitus (1).
Not recommended in patients with severe gastrointestinal disease,
including severe gastroparesis (1,
5.6).
DOSAGE AND ADMINISTRATION
Adult Dosage (2.1)
Recommended starting dosage is 0.75 mg injected subcutaneously once
weekly.
Increase dosage to 1.5 mg once weekly for additional glycemic contr