TRULICITY dulaglutide (rch) 1.5 mg/0.5 mL solution for injection prefilled pen
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
07-07-2021
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
20-05-2019
Active ingredient:
dulaglutide, Quantity: 1.5 mg
Available from:
Eli Lilly Australia Pty Ltd
INN (International Name):
dulaglutide
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: citric acid; water for injections; mannitol; polysorbate 80; sodium citrate dihydrate
Administration route:
Subcutaneous
Units in package:
2, 4
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Type 2 Diabetes Mellitus: glycaemic control - TRULICITY is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: ? As monotherapy. ? In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 for data with respect to different combinations).,Type 2 Diabetes Mellitus: reduction in risk of major adverse cardiovascular events - TRULICITY is indicated as an adjunct to standard of care therapy 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
Product summary:
Visual Identification: Clear, colourless solution, essentially free of visible particles; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Authorization status:
Registered
Authorization date:
2015-01-19
Patient Information leaflet
TRULICITY
®
_SINGLE DOSE PREFILLED PEN (AUTOINJECTOR)_
_Dulaglutide (rch)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine.
It does not contain all the available
information and does not take the
place of talking with your doctor.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine. You can also
download the most up to date leaflet
from www.lilly.com.au. The updated
leaflet may contain important
information about TRULICITY and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has more
information about this medicine than
is contained in this leaflet. Also, your
doctor has had the benefit of taking a
full and detailed history from you
and is in the best position to make an
expert judgement to meet your
individual needs.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT TRULICITY IS
USED FOR
In adults with Type 2 diabetes,
TRULICITY is used to improve
blood sugar control and reduce the
risk of major adverse cardiovascular
events in patients with or without
existing cardiovascular disease.
Diabetes is a condition in which your
pancreas does not produce enough
insulin to control your blood sugar
level.
TRULICITY helps your body to
produce more insulin when your
blood sugar level is high.
TRULICITY may be used alone or
with other medicines to control your
blood sugar levels. Your doctor may
want you to use one or more other
medicines in addition to
TRULICITY, such as metformin,
sulfonylurea, thiazolidinedione
(TZD) or insulin.
TRULICITY has not been studied in
children.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR, DIABETES NURSE O
Read the complete document
Summary of Product characteristics
vA6.0_Jul2020
Supersedes: v5.0_July2019
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION – TRULICITY (DULAGLUTIDE RCH)
AUTOINJECTOR
1.
NAME OF THE MEDICINE
dulaglutide (rch)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRULICITY contains dulaglutide (rch) 1.5 mg per 0.5 mL solution.
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Solution for Injection.
TRULICITY is a clear, colourless, essentially free from particles,
sterile and non-pyrogenic solution
for subcutaneous administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Type 2 Diabetes Mellitus: glycaemic control
TRULICITY is indicated as an adjunct to diet and exercise to improve
glycaemic control in adults
with type 2 diabetes mellitus:
•
As monotherapy.
•
In combination with other glucose-lowering medicinal products
including insulin, when
these, together with diet and exercise, do not provide adequate
glycaemic control_ _(see
section 5.1 for data with respect to different combinations).
Type 2 Diabetes Mellitus: reduction in risk of major adverse
cardiovascular events
TRULICITY is indicated as an adjunct to standard of care therapy 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
vA6.0_Jul2020
Supersedes: v5.0_July2019
Page 2 of 23
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
TRULICITY should be administered once weekly. The dose can be
administered at any time of the
day, with or without meals, and can be injected subcutaneously in the
abdomen, thigh or upper
arm. TRULICITY should not be administered intravenously or
intramuscularly. TRULICITY is for
single use in one patient only. Discard the pen once the injection is
completed.
USE IN ADULTS (≥ 18 YEARS)
The recommended dose of TRULICITY is 1.5 mg per week. Administer
TRULICITY once weekly, at
any time of day, independently of meals.
USE IN THE ELDERLY (≥ 65 YEARS)
No dose adjustment is required based on age.
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