SOMATULINE LA lanreotide 30mg (as acetate) powder for injection vial with diluent ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lanreotide acetate

Available from:

Ipsen Pty Ltd

Authorization status:

Registered

Patient Information leaflet

SOMATULINE
®
LA
30MG
_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 LA. Its active ingredient
is lanreotide. The dose of lanreotide
you will receive is 30 mg. There is an
extra amount (10 mg) filled into the
vial to ensure that the correct dose
can be injected. The formulation
contains a mixture of copolymers,
mannitol, polysorbate 80 and
carmellose sodium. For the injection,
the Somatuline LA will be made up
with the suspension vehicle which
contains mannitol in water for
injection.
The product is for single use only.
Your doctor or nurse will make up
the injection and give it to you as
described in the instructions.
WHAT IS SOMATULINE
LA?
Somatuline LA 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
LA USED FOR?
Somatuline LA is recommended 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.
BEFORE YOU ARE GIVEN
SOMATULINE LA
_WHEN YOU MUST NOT BE GIVEN_
_IT_
Do not be given Somatuline LA if
•
you are breastfeeding
•
you are allergic to lanreotide, the
active ingredient of Somatuline
LA, or any other somatostatin
analogue.
Signs of an allergic reaction may
include itchy skin rash, shortness of
breath and swelling of the face or
tongue.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF:
•
you think you are allergic to any
ingredients contained in
Somatuline LA.
•
you are a diabetic.
•
you have ever experienced liver,
kidney, thyroid or gal

Summary of Product characteristics

Somatuline LA Product Information V2.5 16 Dec 2014
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PRODUCT INFORMATION
SOMATULINE LA 30MG
NAME OF MEDICINE
Lanreotide (I.N.N., B.A.N.) _acetate_
DESCRIPTION
Powder for suspension for injection. Somatuline LA is formulated as a
prolonged -
release depot suspension of lanreotide acetate for intramuscular
injection. The slow
release properties of the formulation have been achieved by
encapsulation of lanreotide
in microspheres composed of a biodegradable matrix of copolymers. The
gradual
degradation of the matrix after injection results in prolonged release
of the active drug.
Each vial is filled with a quantity of microparticles which ensures
the injection of 30 mg of
lanreotide. Lanreotide is a peptide containing eight amino acids as
shown below:
S -------------------------- S
| |
D-ß-Nal-Cys-Tyr-D-Trp-Lys-Val-Cys-Thr-NH2
Molecular formula : C
54
H
69
N
11
O
10
S
2
CAS : 108736-35-2
Excipients include polyglactin, lactic-glycolic copolymer, mannitol,
carmellose sodium,
polysorbate 80.
PHARMACOLOGY
Like natural somatostatin, lanreotide is a peptide inhibitor of a
number of endocrine,
neuroendocrine, exocrine and paracrine functions. It shows good
affinity for peripheral
somatostatin receptors (anterior pituitary and pancreatic). In
contrast, its affinity for central
receptors is much lower. This profile confers a good specificity of
action at the level of
growth hormone secretion.
Lanreotide shows a much longer duration of action than natural
somatostatin. In addition,
its marked selectivity for the secretion of growth hormone, compared
to that of insulin,
makes it a suitable candidate for the treatment of acromegaly.
PHARMACOKINETICS
The plasma profile of lanreotide administered intramuscularly as the
Somatuline LA
prolonged release formulation in healthy volunteers, is characterised
by an initial rapid
release phase (phase 1) followed by a prolonged slow release phase
(phase 2). The plasma
peak (C
max
: 8.5 ± 4.7mg/l) occurs between 1 and 2 hours post-dosing. It is
followed by a
decay during the days 1-