Firmagon 80mg Powder and Solvent for Solution for Injection

País: Malasia

Idioma: inglés

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

Ingredientes activos:

DEGARELIX

Disponible desde:

Ferring Sdn. Bhd.

Designación común internacional (DCI):

DEGARELIX

Unidades en paquete:

1units Units

Fabricado por:

FERRING GMBH

Información para el usuario

Not Applicable

Ficha técnica

MY FIRMAGON 80mg Proposed for COS to FGmbH (#77074)
52- I-MY -0 4.0 1 drafted by JIWO 29- Jul-2016 ; LAC approval: NA
FIRMAGON ® 80mg
Powder and solvent for solution for injection
QUALITATIVE AND QUANTITATIVE C OMPOSITION
Each vial contains 80 mg d egarelix (as acetate). After reconstitution, each ml solution contains 20 mg of
degarelix.
List of excipients :
Powder: Mannitol (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 (G nRH) 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 consecuti ve
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 cas tration (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 reconstitution a