SOMATULINE AUTOGEL (lanreotide as acetate) 60mg solution for injection prefilled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lanreotide acetate, Quantity: 77.9 mg (Equivalent: lanreotide, Qty 65.4 mg)

Available from:

Ipsen Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; glacial acetic acid

Administration route:

Subcutaneous

Units in package:

1 prefilled syringe delivering 60mg lanreotide

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Somatuline Autogel is indicated for: - the treatment of acromegaly when the circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory -the treatment of symptoms of carcinoid syndrome associated with carcinoid tumours -the treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.

Product summary:

Visual Identification: Pre-filled syringe containing a white to off-white translucent semi-solid phase, practically free from visible particulates.; Container Type: Syringe; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2003-09-11

Patient Information leaflet

SOMATULINE
®
AUTOGEL
®
_60, 90 AND 120 MG_
_Lanreotide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully. It
provides some information about
your medicine. If you have any
questions or are not sure about
anything after you have read this
leaflet, please ask your doctor or
pharmacist.
The name of your medicine is
Somatuline
®
Autogel
®
. Somatuline
Autogel is a solution for injection in
a pre-filled syringe, ready to use and
fitted with an automatic safety
system. It is a white to pale yellow
semi-solid formulation. The active
substance is lanreotide. The dose of
lanreotide you will receive is 60, 90
or 120 mg. There is an extra amount
filled into the syringe to ensure that
the correct dose can be injected. The
other ingredients are sterile water and
acetic acid.
The product is for single use only.
WHAT IS SOMATULINE
AUTOGEL?
Somatuline Autogel is a prolonged
release formulation of lanreotide.
Lanreotide is an octapeptide, an
analogue of a naturally occurring
hormone, somatostatin. Lanreotide
lowers the levels of hormones in the
body such as GH (growth hormone)
and IGF-1 (insulin-like growth
factor-1).
WHAT IS SOMATULINE
AUTOGEL USED FOR?
Somatuline Autogel is used for the
treatment of acromegaly when the
circulating levels of growth hormone
and IGF-1 remain abnormal after
surgery and/or radiotherapy, or in
patients who do not respond to
therapy with drugs called dopamine
agonists.
Somatuline Autogel is used for the
treatment of symptoms associated
with carcinoid syndrome, such as
flushing and diarrhoea.
Somatuline Autogel is used for the
treatment and control of the growth
of some advanced tumours of the
intestine and pancreas that cannot be
removed by surgery (called
gastroenteropancreatic
neuroendocrine tumours or GEP-
NETs).
BEFORE YOU ARE GIVEN
SOMATULINE
AUTOGEL
_WHEN YOU MUST NOT BE GIVEN_
_IT_
Do not be given Somatuline Autogel
if:
•
you are breastfeeding
•
you have a tumour blocking your
intestines
•
you are allergic to lanreotide, the
active ingredient o

Summary of Product characteristics

Somatuline Autogel
Product Information V6, 20 November 2020
1
AUSTRALIAN PRODUCT INFORMATION
SOMATULINE AUTOGEL
LANREOTIDE (AS ACETATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
lanreotide acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Somatuline Autogel pre-filled syringe contains a supersaturated
solution of lanreotide
acetate corresponding to 24.6 mg of lanreotide base per 100 mg of
solution, which ensures an
actual injection dose of 60mg, 90mg or 120mg of lanreotide,
respectively. It is a white to pale-
yellow semi-solid formulation and is formulated as a prolonged-release
solution of lanreotide
acetate for deep subcutaneous injection. Prolonged release of the
peptide is achieved by the
physical nature of the supersaturated solution.
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Somatuline Autogel is a white to pale-yellow semi-solid formulation
solution for injection in
a prefilled clear polypropylene syringe.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Somatuline Autogel is indicated for:
-
the treatment of acromegaly when the circulating levels of growth
hormone and IGF-1
remain abnormal after surgery and/or radiotherapy or in patients who
are dopamine
agonist treatment refractory
-
the treatment of symptoms of carcinoid syndrome associated with
carcinoid tumours
-
the treatment of gastroenteropancreatic neuroendocrine tumours
(GEP-NETs) in adult
patients with unresectable locally advanced or metastatic disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Acromegaly: _
In patients receiving a somatostatin analogue for the first time, the
recommended starting dose
is 60 mg of Somatuline Autogel administered every 28 days.
In patients previously treated with Somatuline LA once every 14 days,
the initial dose of
Somatuline Autogel should be 60 mg every 28 days; in patients
previously treated with
Somatuline LA once every 10 days, the initial dose of Somatuline
Autogel should be 90 mg
Somatuline Autogel
Product Information V6, 20 November 2020
2
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