FIRMAGON 80 mg powder and solvent for solution for injection

FIRMAGON contains degarelix.
Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer. 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.

Do not use FIRMAGON

• If you are allergic (hypersensitive) to degarelix or any of the other ingredients of FIRMAGON.

Take special care with FIRMAGON

Please tell your doctor if you have any of the following:

• 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.

Using other medicines

FIRMAGON might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or other medicines which can have an effect on heart rhythm (e.g. methadone, cisapride, moxifloxacine, antipsychotics).

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Driving and using machines

Tiredness and dizziness are common side effects that may impaire your ability to drive and use machines. These side effects may be due to the treatment or effects resulting from the underlying disease.

This medicine is usually injected by a nurse or a doctor.

The usual starting dose is two injections of 120 mg. After that, you will receive a monthly 80 mg injection. The injected liquid forms a gel from which a continuous release of degarelix takes place over a period of one month.

FIRMAGON must be injected under the skin (subcutaneously) ONLY. FIRMAGON must NOT be given into a blood vessel (intravenously). Precautions must be taken to avoid accidental injection into a vein. The site of injection is likely to vary within the abdominal region.

If you forget to use FIRMAGON

If you believe your monthly dose of FIRMAGON has been forgotten, please talk to your doctor. If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, FIRMAGON can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

• very common (affects more than 1 user in 10)
• common (affects 1 to 10 users in 100)
• uncommon (affects 1 to 10 users in 1,000)
• rare (affects 1 to 10 users in 10,000)
• very rare (affects less than 1 user in 10,000)
• not known (frequency cannot be estimated from the available data)

Very commonHot flushes, injection site pain and redness.

Common

• injection site swelling, node and hardness
• chills, fever or influenza-like illness after the injection
• trouble sleeping, tiredness, dizziness, headache
• increased weight, nausea, diarrhoea, elevated levels of some liver enzymes
• excessive sweating (including night sweats), rash
• anaemia
• musculoskeletal pain and discomfort
• reduced size of testicles, breast swelling, impotence

Uncommon

• loss of sexual desire, testicular pain, pelvic pain, ejaculation failure, genital irritation, breast pain
• depression, mental impairment
• skin redness, loss of hair, skin nodule, numbness
• allergic reactions, hives, itching
• decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar/diabetes mellitus, increased cholesterol, changes in blood calcium, decreased weight
• high blood pressure, changes in heart rhythm, changes in ECG (QT-prolongation), feeling of abnormal heart beat, dyspnoea, peripheral oedema
• muscular weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, pain in the joint
• frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at night, impaired renal function, incontinence
• blurred vision
• discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction)
• malaise

Side effects at the injection site are most common with the starting dose and less common with the maintenance dose.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use FIRMAGON after the expiry date which is stated on the vials and outer packaging. The expiry date refers to the last day of that month.

After reconstitution:
Chemical and physical in-use stability has been demonstrated for 2 hours at 25ºC. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

What FIRMAGON contains

• The active substance is degarelix, each vial contains 80 mg degarelix. After reconstitution 1 ml of the reconstituted solution contains 20 mg degarelix.
• The other ingredient of the powder is mannitol (E 421).
• The solvent is water for injections.

What FIRMAGON looks like and contents of the pack

FIRMAGON is a powder for solution for injection. The powder is white to off-white. The solvent is a clear, colourless solution.

1 pack contains:

1 vial with powder containing 80 mg of degarelix and 1 vial with 6 ml of solvent. 1 syringe, 2 vial adapters and 1 injection needle.

3 pack contains:

3 x 1 vial with powder containing 80 mg of degarelix and 3 x 1 vial with 6 ml of solvent. 3 x 1 syringe, 3 x 2 vial adapters and 3 x 1 injection needle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11
DK-2300 Copenhagen S
Denmark
Tel. +45 8833 8834

Manufacturer:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien NV Ferring SA Hopmarkt 9 b.3 B-9300 AalstAlost TelTél 32-53 72 92 00 ferringnvsaferring.be LuxembourgLuxemburg NV Ferring SA Hopmarkt 9 b.3 B-9300 AlostAalst TélTel 32-53 72 92 00 ferringnvsaferring.be

Magyarország Ferring Magyarország Gyógyszerkereskedelmi Kft. Váci út 140. H-1138 Budapest Tel. 36 1 236 3800 ferringferring.hu 1612 .. . 16 . 359 2 895 21 10 BulgariaInfopharmaswiss.com

eská republika Ferring Pharmaceuticals CZ s.r.o. K Rybníku 475 PS 252 42 Jesenice u Prahy Tel 420 241 041 111 czinfoferring.com Malta E.J. BUSUTTIL LTD NICHE Apts., No. 1, TRIQ IX-XORROX BKARA BKR 1633 MALTA Tel 356 21447184 adminejbusuttil.com

Nederland Ferring BV Postbus 184 NL-2130 AD HOOFDDORP Tel 31-235680300 Danmark Ferring Lægemidler AS Kay Fiskers Plads 11 DK-2300 København S Tlf 45 88 16 88 17 ferringferring.dk

Deutschland Ferring Arzneimittel GmbH Fabrikstraße 7 D-24103 Kiel Tel 49-0431-5852 0 info-serviceferring.de Norge Ferring Legemidler AS Nydalsveien 36B Postboks 4445 Nydalen N-0403 Oslo Tlf 47 22 02 08 80 mailoslo.ferring.com

Eesti Österreich

MediNet International Ltd Narva mnt. 11D EE 10151 Tallinn Tel 372 62 61 025 Ferring Arzneimittel GesmbH Wienerbergstraße 11 A-1100 Wien Tel 43 1 60 808 0 officeferring.at

Ferring 3 GR 151 25 30 210 68 43 449 Polska Ferring Pharmaceuticals B.V., Sp. z o.o. Przedstawicielstwo w Polsce Ul. Królowej Marysieki 11 m. 4 PL 02-954 Warszawa Tel. 48 22 842 71 00 ferringferringpl.com.pl

España Ferring, S.A.U. C Gobelas, n 11 E-28023 Madrid Tel 34 91 799 47 80 Portugal Ferring Portuguesa Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Rua Alexandre Herculano, Edifício 1, Piso 6 P-2795-240 Linda-a-Velha Tel 351 21 940 51 90

France Ferring S.A.S. 7, rue Jean-Baptiste Clément F-94250 Gentilly Tél 33 1 49 08 91 23 România Ferring Pharmaceuticals SA Reprezentana în România Str. C.A. Rosetti nr. 17, biroul 501 Bucureti 020011 RO Tel 40 21 527 03 02

Slovenija PharmaSwiss d.o.o. Wolfowa 1 SI-1000 Ljubljana Tel 386 1 23 64 700 SloveniaInfopharmaswiss.com Ireland Ferring Ireland Ltd. United Drug House Magna Drive Magna Business Park Citywest Road IRL - Dublin 24 353 01 4637355

Ísland Vistor hf. Hörgatúni 2 IS-210 Garðabæ Sími 354 535 70 00 Slovenská republika Ferring Pharmaceuticals SA BC Aruba, Galvaniho 7D SK-821 04 Bratislava Tel 421 2 54 416 010 SK0-Recepciaferring.com

Italia Ferring S.p.A. Via Senigallia 182 I-20161 Milano Tel 39 02 640 00 11 SuomiFinland Ferring Lääkkeet Oy PL 23 FIN-02241 Espoo PuhTel 358-207 401440

. . T.. 21148 CY 1502 357 22490305 Sverige Ferring Läkemedel AB Box 4041 SE-203 11 Malmö Tel 46 40 691 69 00 infoferring.se

Latvija MediNet International Ltd Ojra Vciea iela 13 Rga LV-1004 Tel 371 67 805 140 United Kingdom Ferring Pharmaceuticals Ltd The Courtyard, Waterside Drive Langley, Berkshire, SL3 6EZ UK Tel 01753 214800 ContactFerring.co.uk

Lietuva
MediNet International Ltd
Laisv-s pr. 75
LT-06144 Vilnius
Tel: + 370 52 688 490

This leaflet was last approved in {MM/YYYY}.

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The following information is intended for medical or healthcare professionals only:

Instructions for proper use

NOTE:

• DO NOT SHAKE THE VIALS

The pack contains 1 set of powder and solvent that must be prepared for subcutaneous injection.

1. Remove the cover from the vial adapter pack. Attach the adapters to both the solvent and powder vial by pressing the adapter down until the spike pushes through the rubber stopper and the adapter snap in place. 2. Remove the cover from the syringe pack. Attach the syringe to the solvent vial by screwing it on to the adapter. 3. Turn the vial upside down and draw 4.2 ml of the solvent into the syringe. Always make sure to withdraw the precise volume, as the amount of solvent affects the reconstitution. Detach the syringe from the adapter and discard the vial with the remaining solvent.

4. Attach the syringe to the powder vial by screwing it on to the adapter. Transfer the solvent to the powder vial. With the syringe still attached to the adapter, swirl very gently until the liquid looks clear and without undissolved powder or particles. In case the powder adheres to the vial over the liquid surface, the vial can be tilted slightly. AVOID SHAKING TO PREVENT FOAM FORMATION. A ring of small air bubbles on the surface of the liquid is acceptable. The reconstitution procedure may take, in some cases, up to 15 minutes, but usually takes a few minutes. 5. Turn the vial upside down and, holding it vertically, draw 4.0 ml of the solution into the syringe for injection. Always make sure to withdraw the precise volume. It can be necessary to tilt the vial slightly. 6.Detach the syringe from the vial adapter and attach theneedle for deep subcutaneous injection to the syringe. Carefully remove any air bubbles. 7. Grasp the skin of the abdomen, elevate the subcutaneous tissue. Perform a profound subcutaneous injection. To do so, insert the needle deeply at an angle of not less than 45 degrees. 8. Inject 4.0 ml of FIRMAGON 80 mg immediately after reconstitution. 9. Do not inject directly into a vein. Gently pull back the plunger to check if blood is aspirated. If blood appears in the syringe, the medicinal product can no longer be used. Discontinue the procedure and discard the syringe and the needle reconstitute a new dose for the patient.

Please be aware:

• No injections should be given in areas where the patient will be exposed to pressure, e.g. around the belt or waistband or close to the ribs.

Chemical and physical in-use stability has been demonstrated for 2 hours at 25C. From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.