LYXUMIA lixisenatide 10 mcg (0.05mg/mL) solution for injection injector pen

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lixisenatide

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Lixisenatide

Authorization status:

Registered

Patient Information leaflet

Property of the Sanofi group
Page 1
LYXUMIA
®
_lixisenatide _
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lyxumia.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Lyxumia
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT LYXUMIA IS
USED FOR
Lyxumia contains the active
substance lixisenatide.
Lyxumia is a medicine used to
control the blood sugar level when
it is too high in adult patients with
type 2 diabetes mellitus.
Lyxumia is used with other
antidiabetic medicines for diabetes
when they are not enough to control
your blood sugar levels. Your
doctor will prescribe the best
combination to manage your type 2
diabetes mellitus.
It is also important to control your
diet and exercise while using
Lyxumia.
CHECK WITH YOUR DOCTOR OR
HEALTHCARE PROFESSIONAL IF YOU ARE
NOT SURE WHETHER YOUR ANTIDIABETIC
MEDICINES CONTAIN A SULFONYLUREA OR
BASAL INSULIN.
Diabetes mellitus is a condition in
which your pancreas does not produce
enough insulin to control your blood
sugar (glucose) level. Lyxumia helps
to control your blood sugar levels only
when it is too high.
Lyxumia is not a substitute for insulin
in patients who require insulin
treatments for their diabetes. In some
cases it may be used as well as insulin.
Your doctor, however, may have
prescribed Lyxumia for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with a
doctor's prescription.
BEFORE YOU USE
LYXUMIA
WHEN YOU MUST NOT USE IT
DO NOT USE LYXUMIA IF:
•
you have type 1 diabetes or
diabetic ketoacidosis (often caused by
very high blood glucose levels).
•
you are allergic to lixisenatide or
meta-cresol or any

Summary of Product characteristics

lyxumia-ccdsv5-piv6-1dec20
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION – LYXUMIA
(LIXISENATIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Lixisenatide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lyxumia is available as 2 different injector pens which deliver either
a dose of 10 μg (0.05
mg/mL) or 20 μg (0.1 mg/mL) of lixisenatide in 0.2 mL.
Each injector pen contains 3 mL solution delivering 14 doses of 10 μg
or 20 μg lixisenatide.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection
Lyxumia is a clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lyxumia is indicated for the treatment of adults with type 2 diabetes
mellitus to achieve
glycaemic control in combination with metformin, metformin and
sulphonylurea, basal
insulin and metformin, basal insulin and sulphonylurea when these,
together with diet and
exercise, do not provide adequate glycaemic control (see Sections 5.1
Pharmacodynamic
properties, Clinical trials, and 4.4 Special warnings and precautions
for use, Risk of
hypoglycaemia,) for available data on the different combinations.
4.2
DOSE AND METHOD OF ADMINISTRATION
Lyxumia is to be injected subcutaneously in the thigh, abdomen or
upper arm. Lyxumia
should not be administered intravenously or intramuscularly.
Lyxumia is administered once daily within the hour before a meal
(either breakfast, lunch or
dinner).
It is preferable that the prandial injection of Lyxumia is performed
before the same meal every
day, when the most convenient meal has been chosen.
The starting dose is 10 micrograms (µg) Lyxumia once daily for 14
days.
lyxumia-ccdsv5-piv6-1dec20
Page 2 of 27
Then, the Lyxumia dose should be increased to 20 micrograms (µg) once
daily, which is the
maintenance dose.
If a dose of Lyxumia is missed, it should be injected within the hour
prior to the next meal.
When Lyxumia is added to existing metformin therapy, the current
metformin dose can be
continued unchanged.
When Lyxumia is added to a combinati