Firmagon

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

degarelix

Saadav alates:

Ferring Pharmaceuticals A/S

ATC kood:

L02BX02

INN (Rahvusvaheline Nimetus):

degarelix

Terapeutiline rühm:

Endocrine therapy

Terapeutiline ala:

Prostatic Neoplasms

Näidustused:

FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated:- for treatment of adult male patients with advanced hormone-dependent prostate cancer.- for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.- as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Toote kokkuvõte:

Revision: 19

Volitamisolek:

Authorised

Loa andmise kuupäev:

2009-02-17

Infovoldik

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE USER
FIRMAGON 80 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
degarelix
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor.
−
If you get any of the side effects, talk to your doctor. This includes
any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What FIRMAGON is and what it is used for
2.
What you need to know before you use FIRMAGON
3.
How to use FIRMAGON
4.
Possible side effects
5.
How to store FIRMAGON
6.
Contents of the pack and other information
1.
WHAT FIRMAGON IS AND WHAT IT IS USED FOR
FIRMAGON contains degarelix.
Degarelix is a synthetic hormone blocker used in the treatment of
prostate cancer and for the treatment of
high-risk prostate cancer prior to radiotherapy and in combination
with radiotherapy in adult male patients.
Degarelix mimics a natural hormone (gonadotrophin-relasing hormone,
GnRH) and directly blocks its
effects. By doing so, degarelix immediately reduces the level of the
male hormone testosterone that
stimulates the prostate cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FIRMAGON
DO NOT USE FIRMAGON
−
If you are allergic to degarelix or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Please tell your doctor if you have any of the following:
−
Any cardiovascular conditions or heart rhythm problems (arrythmia), or
are being treated with medicines
for this condition. The risk of heart rhythm problems may be increased
when using FIRMAGON.
−
Diabetes mellitus. Worsening or onset of diabetes may occur. If you
have diabetes, you may have to
measure blood glucose more frequently.
−
Liver disease. Liver function may need to be monitored.
−
Kidney disease. Use of FIRMAGON has not been investigated in patients
with severe kidney disease.
−
Osteopor

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
FIRMAGON 80 mg powder and solvent for solution for injection
FIRMAGON 120 mg powder and solvent for solution for injection
2.
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.
For the 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.
- for treatment of high-risk localised and locally advanced hormone
dependent prostate cancer in
combination with radiotherapy.
- as neo-adjuvant treatment prior to radiotherapy in patients with
high-risk localised or locally 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.
FIRMAGON may be used as neo-adjuvant or adjuvant therapy in
combination with radiotherapy in high-risk
localised and locally advanced prostate cancer.
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
3
administration of the starting dose with 96% of the patients having
serum test