FIRMAGON 80 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DEGARELIX AS ACETATE

Available from:

FERRING PHARMACEUTICALS LTD

ATC code:

L02BX02

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

DEGARELIX AS ACETATE 80 MG

Administration route:

S.C

Prescription type:

Required

Manufactured by:

FERRING GmbH ,GERMANY

Therapeutic area:

DEGARELIX

Therapeutic indications:

For the treatment of adult male patients with advanced hormone-dependent prostate cancer.

Authorization date:

2020-02-02

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by doctor’s prescription only
FIRMAGON 80 MG
FIRMAGON 120 MG
POWDER AND SOLVENT FOR PREPARING A SOLUTION FOR SUBCUTANEOUS INJECTION
COMPOSITION:
FIRMAGON 80 MG contains: degarelix (as acetate) 80 mg
FIRMAGON 120 MG contains: degarelix (as acetate) 120 mg
Inactive ingredients – see section 6 “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START
USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
refer to the doctor or the pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others.
It may harm them, even if it seems to you that their illness is
similar.
This medicine is intended for adult men only.
This medicine is not intended for women.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For treatment of advanced prostate cancer in adult men.
THERAPEUTIC GROUP: GnRH antagonist.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients that this
medicine contains.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE THE TREATMENT WITH FIRMAGON, TELL YOUR DOCTOR IF:
•
You have diabetes; your existing diabetes may get worse. If you did
not have diabetes
previously it may occur now. If you have diabetes you must measure
glucose levels in your
blood more often.
•
You have problems with your heart, blood vessels, or heart-rate (heart
rhythm disorders-
arrhythmia), or if you have been given medication to treat this
problem. Heart rhythm
disorders may get worse while using Firmagon.
•
You have or have had in the past impaired function of the liver. Liver
function must be
monitored.
•
You have kidney disease. Treatment with Firmagon has not been tested
in patients with
severe kidney disease.
•
You have osteoporosis or any other condition which may affect

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
FIRMAGON 120 mg
FIRMAGON 80 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 120 mg degarelix (as acetate). After
reconstitution, each ml solution contains 40 mg
of degarelix.
Each vial contains 80 mg degarelix (as acetate). After
reconstitution,each ml of solution contains
20 mg of degarelix.
For a full list of excipients, see section 6.1
.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Powder: White to off-white powder
Solvent: Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist
indicated for treatment of
adult male patients with advanced hormone-dependent prostate cancer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
STARTING DOSE
MAINTENANCE DOSE – MONTHLY
ADMINISTRATION
240 mg administered as two consecutive
subcutaneous injections of 120 mg each
80 mg administered as one subcutaneous
injection
The first maintenance dose should be given one month after the
starting dose.
The therapeutic effect of degarelix should be monitored by clinical
parameters and prostate specific
antigen (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 serum
testosterone levels corresponding to medical castration (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 sufficiently suppressed.
2
Since degarelix does not induce a testosterone surge it is not
necessary to add an anti-androgen as
surge protection at initiation of therapy
.
Special patient populations
_Elderly, hepatically or renally impaired patients: _
There is no need to adjust the dose f