Diphereline

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Triptorelin embonate; Water for injections

Available from:

Ipsen Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

DIPHERELINE™

_Triptorelin embonate_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you are given Diphereline.
This leaflet answers some common
questions about Diphereline. 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. Sometimes new risks are
found even when a medicine has
been used for many years.
Your doctor has weighed the risks of
you being given Diphereline 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 WITH THE MEDICINE.
You may need to read it again.
WHAT DIPHERELINE IS
USED FOR?
The name of your medicine is
Diphereline. It contains the active
ingredient triptorelin embonate.
Diphereline is used to treat prostate
cancer that has spread into
surrounding tissue and/or to other
parts of the body. It is not a cure for
prostate cancer.
Diphereline belongs to a group of
medicines called Gonadotrophin
Releasing Hormone analogues
(GnRHa).
Diphereline works by lowering the
production of testosterone in men.
Testosterone is the natural male sex
hormone.
In some types of prostate cancer,
testosterone may help the cancer
cells to grow. By lowering
testosterone, Diphereline may slow
or stop the growth of cancer.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE GIVEN
DIPHERELINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DIPHERELINE SHOULD ONLY BE GIVEN TO
MEN. IT MUST NOT BE GIVEN TO
WOMEN OR CHILDREN.
DO NOT BE GIVEN DIPHERELINE IF YOU
ARE ALLERGIC TO:
•
triptorelin embonate, the active
ingredient in Diphereline
•
any of the other ingredients listed
at the end of this leaflet, in
particular, polysorbate 80
•
any other anti-hormone medicine
(e.g anti-oestrogen, anti-
androgen, GnRHa).
Signs of an allergic reaction may
include itch

Summary of Product characteristics

Diphereline PI 1,3,6m V2.5 20 August 2013

1 of 12

DIPHERELINE PRODUCT INFORMATION  
NAME OF THE MEDICINE  
_ _
_Triptorelin embonate _ 
DESCRIPTION 
Powder and solvent for suspension for injection, prolonged
release granules._ _
White to off-white powder. 

Structural formula:  

[(L-Pyr)-(L-His)-(L-Trp)-(L-Ser)-(L-Tyr)-(D-Trp)-(L-Leu)-(L-Arg)-(L-Pro)-(Gly-NH
2
)] 

Molecular formula: C
64
H
82
N
18
O
13
 (triptorelin). C
23
H
16
O
6
 (embonate) 

Molecular weight:  
1311.5 (triptorelin) + 
 388.4 (embonate) 

CAS number: 57773-63-4 

_DIPHERELINE 3.75MG 1 MONTH FORMULATION_ 
Each vial contains a triptorelin content which allows the
administration of an effective dose of  
3.75 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of reconstituted suspension 
contains 1.875 mg of triptorelin. 

_DIPHERELINE 11.25MG 3 MONTH FORMULATION _
Each vial contains a triptorelin content which allows the
administration of an effective dose of 
11.25  mg  triptorelin.  After  reconstitution  in  2  mL  of  solvent,  1  mL  of  reconstituted 
suspension contains 5.625 mg of triptorelin. 

_DIPHERELINE 22.5MG 6 MONTH FORMULATION _
Each vial contains a triptorelin content which allows the
administration of an effective dose of 
22.5 mg triptorelin. After reconstitution in 2 mL of solvent, 1 mL of reconstituted suspension 
contains 11.25 mg of triptorelin. 
PHARMACOLOGY 
Pharmacodynamics: 

Triptorelin,  a  gonadotrophin  releasing  hormone  (GnRH)  agonist,  inhibits  gonadotrophin 
secretion when given continuously and in therapeutic doses. Male animal and human studies 
Diphereline PI 1,3,6m V2.5 20 August 2013

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show  that  after  the  administration  of  triptorelin  there  is  an  initial  and  transient  increase  in 
circulating  levels  of  luteinizing�