Firmagon 120mg Powder and Solvent for Solution for Injection

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

DEGARELIX

Verfügbar ab:

Ferring Sdn. Bhd.

INN (Internationale Bezeichnung):

DEGARELIX

Einheiten im Paket:

2units Units

Hergestellt von:

FERRING GMBH

Gebrauchsinformation

Not Applicable

Fachinformation

MY FIRMAGON 120mg proposed insert for COS to FGmbh (#77074)
5 3-I -MY -0 4.0 1 drafted by JIWO : 29- Jul-2016 ; LAC approval: NA
FIRMAGON ® 120mg
Powder and solvent for solution for injection
QUALITATIVE AND QUANTITATIVE C OMPOSITION
Each vial contains 120 mg d egarelix (as acetate). After reconstitution, each ml solution contains 40 mg
of degarelix.
List of excipients :
Powder: Manni tol (E421).
Solvent: Water for injection s.
PHARM ACEUTICAL FORM
Powder and solvent for solution for injection
Powder: W hite to off-white powder.
Solvent : C lear, colourless sol ution.
THERAPEUTIC INDICATIONS
FIRMAGON
® is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult
male patients with advanced hormone- dependent prostate cancer.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Starting dose Maintenance dose – monthly
administration
240 mg administered as two consecu tive
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 c astration (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.
Since degarelix does not induce a testosterone surge it is not necessary to add an anti -androgen as
surge protection at initiation of therapy .
Method of administration
FIRMAGON ® must be reconstituted prior to administration. For instructions on rec