Degarelix Accord

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

degarelix acetate

Available from:

Accord Healthcare S.L.U.

ATC code:

L02BX02

INN (International Name):

degarelix

Therapeutic group:

Other hormone antagonists and related agents

Therapeutic area:

Prostatic Neoplasms

Therapeutic indications:

Degarelix Accord 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.

Authorization status:

Authorised

Authorization date:

2023-09-29

Patient Information leaflet

32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEGARELIX ACCORD 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 side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Degarelix Accord is and what it is used for
2.
What you need to know before you use Degarelix Accord
3.
How to use Degarelix Accord
4.
Possible side effects
5.
How to store Degarelix Accord
6.
Contents of the pack and other information
1.
WHAT DEGARELIX ACCORD IS AND WHAT IT IS USED FOR
Degarelix Accord 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 DEGARELIX ACCORD
DO NOT USE DEGARELIX ACCORD

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
Degarelix Accord.
-
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 Degarelix Accor

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Degarelix Accord 80 mg powder and solvent for solution for injection
Degarelix Accord 120 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Degarelix Accord 80 mg powder and solvent for solution for injection
Each vial contains degarelix acetate equivalent to 80 mg degarelix.
After reconstitution, each ml of the
solution contains 20 mg of degarelix.
Degarelix Accord 120 mg powder and solvent for solution for injection
Each vial contains degarelix acetate equivalent to 120 mg degarelix.
After reconstitution, each ml
of the 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 for injection)
Powder: white or off-white mass or powder.
Solvent: colourless and clear solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Degarelix Accord 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
TABLE 1. STARTING AND MAINTENANCE DOSE OF DEGARELIX ACCORD
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.
Degarelix Accord may be used as neo-adjuvant or adjuvant therapy in
combination with
radiotherapy in high-risk localised and locally advanced prostate
cancer.
3
The therapeutic effect of degarelix should be monitored by clinical
parameters and prostate
specific antigen