FIRMAGON degarelix (as acetate) composite 120 mg powder in vial and solvent for injection in pre-filled syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

water for injections, Quantity: 3 mL

Available from:

Ferring Pharmaceuticals Pty Ltd

INN (International Name):

Degarelix,water for injections

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients:

Administration route:

Subcutaneous

Units in package:

2x120mg vials and 2x diluent syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FIRMAGON is a GnRH receptor blocker indicated for treatment of patients with prostate cancer in whom androgen deprivation is warranted.

Product summary:

Visual Identification: Clear, colourless; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-10-31

Patient Information leaflet

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 medicines
•
any ot

Summary of Product characteristics

1
#22606-v16A
AUSTRALIAN PI - FIRMAGON
® (DEGARELIX (AS ACETATE))
POWDER AND SOLVENT FOR INJECTION, DEPOT
1 NAME OF THE MEDICINE
Degarelix (as acetate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3 PHARMACEUTICAL FORM
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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FIRMAGON is a GnRH receptor blocker indicated for treatment of
patients with prostate cancer in
whom androgen deprivation is warranted.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE FOR ADULT MALES
STARTING DOSE
MAINTENANCE DOSE – MONTHLY
ADMINISTRATION
240 mg administered as two s.c. injections
of 120 mg at a concentration of 40 mg/mL
80 mg administered as one s.c. injection at
a concentration of 20 mg/mL
The first maintenance dose should be given one month after the
starting dose.
The therapeutic effect of FIRMAGON should be monitored by clinical
parameters and by measuring
PSA serum levels. Clinical studies have shown that testosterone (T)
suppression occurs immediately
after administration of the starting dose with 96% of the patients
having plasma testosterone at medical
castration levels (T≤0.5 ng/mL) after three days and 100% after one
month. Long term treatment with
the maintenance dose up to 1 year shows that 97% of the patients have
sustained suppressed
testosterone levels (T≤0.5 ng/mL).
In case the patient's clinical response appears to be sub-optimal, it
should be confirmed that serum
testosterone levels are remaining su