FIRMAGON Powder and Solvent for Solution for Injection 80 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Degarelix acetate 88.2 mg eqv degarelix

Available from:

FERRING PHARMACEUTICALS PRIVATE LIMITED

ATC code:

L02BX02

Dosage:

80 mg

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Degarelix acetate 88.2 mg eqv degarelix 80 mg

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Rentschler Biopharma SE (Powder)

Authorization status:

ACTIVE

Authorization date:

2013-05-13

Patient Information leaflet

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FIRMAGON
®
80mg
Powder and solvent for solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 80 mg degarelix (as acetate). After reconstitution,
each ml of solution
contains 20 mg of degarelix.
List of excipients:
Powder: Mannitol (E421).
Solvent: Water for injections.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Powder: White to off-white powder.
Solvent: Clear, colourless solution.
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 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.
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 and
administration, please see section Instructions For Use.
FIRMAGON
®
is for subcutaneous use ONLY, not to be administe

Summary of Product characteristics

FIRMAGON
® 80MG AND 120MG
Powder and solvent for solution for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
FIRMAGON 80 mg powder and solvent for solution for injection
Each vial contains 80 mg degarelix (as acetate). After reconstitution,
each ml of
solution contains 20 mg of degarelix.
FIRMAGON 120 mg powder and solvent for solution for injection
Each vial contains 120 mg degarelix (as acetate). After
reconstitution, each ml of
solution contains 40 mg of degarelix.
List of excipients:
Powder: Mannitol (E421).
Solvent: Water for injections.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
Powder: white to off-white powder.
Solvent: clear, colourless solution.
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
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.
Since degarelix does not induce a testosterone surge it is not
necessary to add an
anti-androgen as surge protection at initiation of therapy