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ELIGARD
®
1
Eligard
®
Leuprorelin (LOO-pro-rel-in) acetate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Eligard
®
. 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 being given
Eligard
®
against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
What Eligard
®
is used
for
Eligard
®
is used to reduce the
symptoms of advanced cancer of the
prostate gland.
This medicine is similar to a
hormone called gonadotrophin
releasing hormone, which is
normally released from the brain.
When it is given regularly to males,
this medicine works by reducing the
amount of testosterone produced.
This inhibits the growth of prostate
cancers which rely on testosterone to
grow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
Before you are given
Eligard
®
When you must not be given
it
YOU MUST NOT BE GIVEN ELIGARD
®
IF
YOU HAVE AN ALLERGY TO:
• any medicine containing
leuprorelin
• any of the ingredients listed at the
end of this leaflet
• any other similar medicines, such
as goserelin.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching, or h
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Product Information
Version 11.0
1
ELIGARD
®
NAME OF THE MEDICINE
Leuprorelin acetate
CAS: 74381-53-6
DESCRIPTION
Eligard
®
is a sterile polymeric matrix formulation of leuprorelin acetate
for subcutaneous
injection. It is designed to deliver leuprorelin acetate at a
controlled rate over a therapeutic
period.
Leuprorelin acetate is a synthetic nonapeptide analogue of naturally
occurring gonadotropin
releasing hormone (GnRH or LH-RH) that, when given continuously,
inhibits pituitary
gonadotropin secretion and suppresses testicular steroidogenesis.
The analogue possesses
greater potency than the natural hormone. The chemical name is
5-oxo-L-prolyl-L-histidyl-
L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide
acetate
(salt).
COMPOSITION
Eligard
®
is available in a single use kit. The kit consists of a
two-syringe mixing system, a
20-gauge half-inch needle (for Eligard
®
1 month and Eligard
®
3 month) or a 20-gauge 5/8-
inch needle (for Eligard
®
4 month) or a 18-gauge 5/8-inch needle (for Eligard
®
6 month), a
silicone desiccant pouch to control moisture uptake, and package
insert for constitution and
administration procedures. Each syringe is individually packaged.
One contains the Atrigel
®
Delivery System and the other contains leuprorelin acetate.
Eligard
®
is prefilled and supplied in two separate, sterile syringes whose
contents are mixed
immediately prior to administration. The two syringes are joined and
the single dose product
is mixed until it is homogenous. Eligard
®
is administered subcutaneously where it forms a
solid drug delivery depot.
Product Information
Version 11.0
2
The Atrigel
®
Delivery System is a polymeric (non-gelatin containing) delivery
system
consisting of a biodegradable polyglactin. The polymer is dissolved in
a biocompatible
solvent, _N_-methyl-2-pyrrolidone. The polyglactin mixture and
volume differ with each
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