Firmagon

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Degarelix; Water for injections

Disponible depuis:

Ferring Pharmaceuticals Pty Ltd

classe:

Medicine Registered

Notice patient

FIRMAGON
®

_Degarelix (as acetate)_
POWDER AND SOLVENT FOR INJECTION, DEPOT
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Firmagon.
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/being given
Firmagon 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 FIRMAGON IS
USED FOR
Firmagon contains degarelix.
Degarelix is a synthetic hormone that
reduces the level of the male
hormone, testosterone.
Firmagon is used to treat:
•
prostate cancer
Firmagon may slow or stop the
growth of cancer.
Firmagon should only be taken by
men. It should not be taken by
women or children.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY FIRMAGON HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Firmagon for another reason.
Firmagon is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
FIRMAGON
_WHEN YOU MUST NOT BE GIVEN_
_IT_
FIRMAGON WILL NOT BE GIVEN IF YOU
HAVE AN ALLERGY TO:
•
degarelix, the active ingredient in
Firmagon or any similar drugs,
known as GnRH antagonists
(blockers)
•
any of the other ingredients of
Firmagon listed at the end of this
leaflet.
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 hives on the skin.
YOU MUST NOT BE GIVEN FIRMAGON
AFTER THE EXPIRY DATE (EXP) PRINTED
ON THE PACK.
YOU MUST NOT BE GIVEN FIRMAGON IF
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged, return
it to your pharmacist for disposal.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO:
•
any other medi

Résumé des caractéristiques du produit

1 

#22606-v11A 

FIRMAGON
® 
degarelix (as acetate) 
FIRMAGON 120 mg, powder and solvent for injection, depot 
FIRMAGON 80 mg, powder and solvent for injection, depot 

NAME OF THE MEDICINE 
Degarelix (as
acetate).  Degarelix is a third generation gonadotrophin releasing hormone (GnRH) 
antagonist (blocker).  It is a
synthetic decapeptide, which forms a
depot following subcutaneous 
injection; this depot formation results in a sustained release
of degarelix. 

The structural formula of degarelix is 

N
H
H
N
N
H
H
N
N
H
O
O
O
HN
O
NH
O
NH
H
N
O
O
H
N
N
H
O
OH
O
N
CL
O
H
N
O
NH
N
O
N
H
NH
2
O
O
NH
2
O
2
4
5
6
7
8
9
10
1
3

It has an empirical formula of C
82
H
103
N
18
O
16
Cl and a monoisotopic mass of 1630.75 Da.  CAS Number: 
214766-78-6. 

DESCRIPTION 
FIRMAGON is a sterile, off-white powder plus
a clear, colourless solvent for reconstitution.  The sterile 
powder is a freeze-dried product containing degarelix (as the acetate) and mannitol.  The solvent 
consists of sterile
water for injections.  FIRMAGON delivers degarelix acetate, equivalent to
120 mg of 
degarelix for the starting dose, and 80 mg
of degarelix for the maintenance dose.  The 80 mg vial 
contains 200 mg mannitol and the 120 mg vial contains 150 mg
mannitol.   

Degarelix has a natural propensity to gel in aqueous
media by its inherent physicochemical 
characteristics.  At concentrations above
ca. 1 mg/mL, aqueous degarelix aggregates and cross-links in 
a gel-forming network, resulting in
the formation of a hydrogel.  While the process does
not take place 
visibly in the reconstituted product, the depot formation
happens instantaneously following 
subcutaneous administration.   

PHARMACOLOGY 
PHARMACODYNAMICS 
Degarelix is a selective GnRH receptor antagonist (blocker) that competitivel