Firmagon 120mg powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Degarelix acetate

Available from:

Ferring Pharmaceuticals Ltd

ATC code:

L02BX02

INN (International Name):

Degarelix acetate

Dosage:

120mg

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5015919788876

Patient Information leaflet

5009000349
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.
Rare (may affect up to 1 in 1,000 people)
- febrile neutropenia (very low number of white blood cell in
combination with fever), heart attack, heart failure.
REPORTING OF SIDE EFFECTS
If you get any of the side effects, talk to your doctor. This includes
any
possible side effects not listed in this leaflet. You can also report
side
effects directly (see details below). By reporting side effects you
can
help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
Do not use this medicine after the expiry date which is stated on the
vials, syringes and outer packaging. The expiry date refers to the
last
day of that month.
FIRMAGON contains degarelix.
Degarelix is a synthetic hormone blocker used in the treatment of
prostate cancer in adult male patients. Degarelix mimics a natural
hormone (gonadotrophin-releasing 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.
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.
- Osteoporosis or any condition that affects the strength of your
bones.
Reduced level of testosterone may cause a reduction in bone calcium
(thinning of bones).
- Severe hypersensitivity. Use of FIRMAGON has not been investigated
in patients with severe hypersensitivit

Summary of Product characteristics

OBJECT 1
FIRMAGON 120MG INJECTION
Summary of Product Characteristics Updated 17-May-2017 | Ferring
Pharmaceuticals Ltd
1. Name of the medicinal product
FIRMAGON 120 mg powder and solvent for solution for injection
2. Qualitative and quantitative composition
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.
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.
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.
Special populations
_Elderly, hepatically or renally impaired patients:_
There is no need to