Firmagon: detailed information

Package leaflet: Information for the patient

FIRMAGON 80 mg powder and solvent for injectable solution

degarelix
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor.
If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

What FIRMAGON is and what it is used for
What you need to know before using FIRMAGON
How to use FIRMAGON
Possible side effects
How to store FIRMAGON
Contents of the pack and other information

1. What FIRMAGON is and what it is used for

FIRMAGON contains degarelix.
Degarelix is a synthetic hormonal blocker used in the treatment of prostate cancer and in the treatment of high-risk prostate cancer prior to radiotherapy or in combination with radiotherapy in adult male patients. Degarelix mimics a natural hormone (gonadotropin-releasing hormone, GnRH) and directly blocks its effect. By doing so, degarelix rapidly reduces the level of the male hormone testosterone, which stimulates prostate cancer.

2. What you need to know before using FIRMAGON

Do not use FIRMAGON

If you are allergic to degarelix or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Tell your doctor if you have any of the following conditions:

You have any cardiovascular problems or heart rhythm disorders (arrhythmia), or you are taking medicines to treat such conditions. Heart rhythm problems may worsen during treatment with FIRMAGON.
You have diabetes mellitus. Worsening of existing diabetes or new onset of diabetes may occur. If you have diabetes, your blood glucose levels should be monitored more frequently.
You have liver problems. You may need to have liver function monitored.
You have kidney problems. The use of FIRMAGON has not been studied in patients with severe kidney disease.
You have osteoporosis or any other condition affecting bone strength. Reduced testosterone levels may lead to decreased bone calcium (bone thinning).
You have severe hypersensitivity. The use of FIRMAGON has not been studied in patients with severe hypersensitivity reactions.

Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and FIRMAGON
FIRMAGON may interact with certain medicines used for heart rhythm disorders (e.g.
quinidine, procainamide, amiodarone, and sotalol) or with other drugs that may affect heart rhythm
(e.g. methadone (used for pain relief and as part of drug addiction detoxification treatment), moxifloxacin (an antibiotic), antipsychotics).
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
For athletes
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Driving and using machines
Tiredness and dizziness are common side effects that may affect your ability to drive or operate machinery. These effects may be due to the treatment or to the underlying disease itself.

3. How to use FIRMAGON

This medicine is usually administered by a doctor or nurse.
The recommended initial dose consists of two consecutive 120 mg injections. After this, you will receive a monthly 80 mg injection. The injected liquid forms a gel that releases degarelix over a one-month period.
FIRMAGON must be injected ONLY under the skin (subcutaneously). FIRMAGON must NOT be injected into a blood vessel (intravenously). Precautions must be taken to avoid accidental intravenous injection. The injection site should be rotated within the abdominal area.
If you forget to use FIRMAGON
If you think you have missed your monthly dose of FIRMAGON, inform your doctor. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions to this medicine are rare. Contact your doctor immediately if you develop a severe skin rash, itching, or shortness of breath or difficulty breathing. These may be symptoms of a serious allergic reaction.

Very common (may affect more than 1 in 10 people)
Hot flushes, pain and redness at the injection site. Injection site reactions are more common with the initial dose and less common with the maintenance dose.

Common (may affect up to 1 in 10 people)

swelling, nodules, and hardening at the injection site
chills, fever, or flu-like syndrome after injection
sleep disturbances, fatigue, dizziness, headache
weight gain, nausea, diarrhoea, elevated levels of some liver enzymes
excessive sweating (including night sweats), skin rash
anaemia
muscle and bone pain and disorders
reduction in testicular volume, breast swelling, impotence

Uncommon (may affect up to 1 in 100 people)

loss of sexual desire, testicular pain, pelvic pain, ejaculatory failure, genital irritation, breast pain
depression, psychiatric disturbances
skin redness, hair loss, skin nodules, numbness
allergic reactions, urticaria, pruritus
decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar/diabetes mellitus, increased cholesterol, changes in blood calcium levels, weight loss
increased blood pressure, changes in heart rate, changes in ECG (prolongation of the QT interval), palpitations, dyspnoea, peripheral oedema
muscle weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, joint pain
frequent need to urinate, urgency to urinate, difficulty or pain when urinating, nocturnal urination, impaired kidney function, incontinence
blurred vision
discomfort at the injection site including decreased blood pressure and heart rate (vasovagal reaction)
malaise

Rare (may affect up to 1 in 1,000 people)

Febrile neutropenia (very low white blood cell count in combination with fever), heart attack, heart failure.
Unexplained muscle pain or cramps, tenderness or weakness. Muscle problems may be severe, including muscle breakdown leading to kidney damage.

Very rare (may affect up to 1 in 10,000 people)

Infection, abscess, and necrosis at the injection site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FIRMAGON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vials, syringes, and
packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage precautions.
After reconstitution
This medicine is stable for 2 hours at 25°C.
Due to the risk of microbial contamination, this medicine should be used immediately.
If not used immediately, the responsibility for use of this medicine lies with the user.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What FIRMAGON Contains

The active substance is degarelix. Each vial contains 80 mg of degarelix (as acetate). After reconstitution, 1 ml of the reconstituted solution contains 20 mg of degarelix.
The other ingredient in the powder is mannitol (E421).
The solvent is water for injections.

What FIRMAGON Looks Like and Contents of the Pack
FIRMAGON is a powder and solvent for solution for injection. The powder is white to off-white in appearance.
The solvent is a clear, colourless solution.
FIRMAGON is available in two pack sizes:
Pack containing 1 tray with:
1 vial of powder containing 80 mg of degarelix, 1 pre-filled syringe containing 4.2 ml of solvent,
1 plunger, 1 vial adapter, and 1 injection needle.
Pack containing 3 trays with:
3 vials of powder containing 80 mg of degarelix each, 3 pre-filled syringes containing 4.2 ml of solvent each,
3 plungers, 3 vial adapters, and 3 injection needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ferring Pharmaceuticals A/S
Amager Strandvej 405
2770 Kastrup
Denmark
Tel.: +45 8833 8834

Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For any information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Ferring N.V. CentralPharma Communication UAB
Tel/Tél: +32 53 72 92 00 Tel: +370 5 243 0444
[email protected] [email protected]

България Luxembourg/Luxemburg
Фармонт ЕООД Ferring N.V.
Tel: +359 2 807 5022 Belgique/Belgien
[email protected] Tel/Tél: +32 53 72 92 00
[email protected]

Česká republika Magyarország
Ferring Pharmaceuticals CZ s.r.o. Ferring Magyarország Gyógyszerkereskedelmi Kft.
Tel: +420 234 701 333 Tel: +36 1 236 3800
[email protected] [email protected]

Danmark Malta
Ferring Lægemidler A/S E.J. Busuttil Ltd.
Tlf: +45 88 16 88 17 Tel: +356 21447184
[email protected]

Deutschland Nederland
Ferring Arzneimittel GmbH Ferring B.V.
Tel: +49 431 5852 0 Tel: +31 235680300
[email protected] [email protected]

Eesti Norge
CentralPharma Communication OÜ Ferring Legemidler AS
Tel: +372 601 5540 Tlf: +47 22 02 08 80
[email protected] [email protected]

Ελλάδα Österreich
Ferring Ελλάς MEΠΕ Ferring Arzneimittel Ges.m.b.H.
Tel: +30 210 68 43 449 Tel: +43 1 60 8080
[email protected]

España Polska
Ferring, S.A.U. Ferring Pharmaceuticals Poland Sp. z o.o.
Tel: +34 91 387 70 00 Tel: +48 22 246 06 80
[email protected] [email protected]

France Portugal
Ferring S.A.S. Ferring Portuguesa – Produtos Farmacêuticos, Sociedade Unipessoal, Lda.
Tél: +33 1 49 08 67 60 Tel: +351 21 940 5190
[email protected]

Hrvatska România
Clinres farmacija d.o.o. Ferring Pharmaceuticals Romania SRL
Tel: +385 1 2396 900 Tel: +40 356 113 270
[email protected]

Ireland Slovenija
Ferring Ireland Ltd. SALUS, Veletrgovina, d.o.o.
Tel: +353 1 4637355 Tel: +386 1 5899 179
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Ferring Slovakia s.r.o.
Sími: +354 535 70 00 Tel: +421 2 54 416 010
[email protected]

Italia Suomi/Finland
Ferring S.p.A. Ferring Lääkkeet Oy
Tel: +39 02 640 00 11 Puh/Tel: +358 207 401 440
[email protected]

Κύπρος Sverige
A. Potamitis Medicare Ltd Ferring Läkemedel AB
Tel: +357 22583333 Tel: +46 40 691 69 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
CentralPharma Communication SIA Ferring Ireland Ltd.
Tālr: +371 674 50497 Tel: +353 1 4637355
[email protected] [email protected]

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.

The following information is intended exclusively for healthcare professionals:

Instructions for proper use
NOTE:

DO NOT SHAKE THE VIALS

The package contains a vial of powder and a pre-filled syringe of solvent, which must be
prepared for subcutaneous injection.

	1. Remove the cap from the vial adapter package. Attach the adapter to the powder vial by pressing down until the tip penetrates the rubber stopper and the adapter clicks into place.
2. Prepare the pre-filled syringe by inserting the plunger.
	3. Remove the cap from the pre-filled syringe. Attach the syringe to the powder vial by screwing it onto the adapter. Transfer all the solvent into the powder vial.
	4. While keeping the syringe attached to the adapter, gently swirl until the solution becomes clear and free of particles or undissolved powder. If powder adheres to the vial above the liquid surface, the vial may be tilted slightly. Avoid shaking to prevent foam formation. The formation of a ring of small air bubbles on the surface of the liquid is acceptable. Reconstitution usually takes a few minutes, but in some cases may require up to 15 minutes.
	5. Invert the vial and draw back the plunger to the syringe's marked line for injection. Always ensure the exact volume is drawn up, adjusting for any air bubbles.
6. Detach the syringe from the adapter and attach the deep subcutaneous injection needle to the syringe.
	7. Administer a deep subcutaneous injection. To do so: grasp the abdominal skin, lift the subcutaneous tissue, and insert the needle deeply at an angle of not less than 45 degrees. Inject slowly 4 ml of FIRMAGON 80 mg immediately after reconstitution.*
8. Injections should not be administered in areas where the patient may be exposed to pressure, such as the belt line, areas with tight bands, or near the ribs. Do not inject directly into a vein. Gently pull back the syringe plunger to check for blood aspiration. If blood appears in the syringe, do not use the medication; discontinue the procedure and discard the syringe and needle (reconstitute a new dose for the patient).

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

Patient information leaflet

FIRMAGON 120 mg powder and solvent for injectable solution

degarelix
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor.
If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

What FIRMAGON is and what it is used for
What you need to know before using FIRMAGON
How to use FIRMAGON
Possible side effects
How to store FIRMAGON
Contents of the pack and other information

1. What FIRMAGON is and what it is used for

2. What you need to know before using FIRMAGON

Do not use FIRMAGON

If you are allergic to degarelix or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Inform your doctor if you are in any of the following conditions:

You have any cardiovascular problems or heart rhythm disorders (arrhythmia), or if you are taking medicines to treat such conditions. Heart rhythm problems may worsen during treatment with FIRMAGON.
You have diabetes mellitus. Worsening of existing diabetes or new onset of diabetes may occur. If you have diabetes, your blood glucose levels should be monitored more frequently.
You have liver problems. You may need to have your liver function checked.
You have kidney problems. The use of FIRMAGON has not been studied in patients with severe kidney disease.
You have osteoporosis or any other condition affecting bone strength. Reduced testosterone levels may lead to decreased bone calcium (bone thinning).
You have severe hypersensitivity. The use of FIRMAGON has not been studied in patients with severe hypersensitivity reactions.

Children and adolescents
Do not give this medicine to children or adolescents.
Other medicines and FIRMAGON
FIRMAGON may interfere with certain medicines used for heart rhythm disorders (e.g.
quinidine, procainamide, amiodarone and sotalol) or with other drugs that may affect heart rhythm
(e.g. methadone (used for pain relief and as part of drug addiction detoxification treatment), moxifloxacin (an antibiotic), antipsychotics).
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
For athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Driving and using machines
Fatigue and dizziness are common side effects that may impair the ability to drive or operate machinery. These effects may be due to the treatment itself or to the underlying disease.

3. How to use FIRMAGON

This medicine is usually administered by a doctor or a nurse.
The recommended initial dose consists of two consecutive 120 mg injections. After that, you will receive a monthly 80 mg injection. The injected liquid forms a gel that releases degarelix over a period of one month.
FIRMAGON must be injected ONLY under the skin (subcutaneously). FIRMAGON must NOT be injected into a blood vessel (intravenously). Precautions must be taken to avoid accidental intravenous injection. The injection site should be rotated within the abdominal area.
If you forget to use FIRMAGON
If you think you have missed your monthly dose of FIRMAGON, inform your doctor. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions to this medicine are rare. Contact your doctor immediately if you develop a severe rash, itching or shortness of breath or difficulty breathing. These may be symptoms of a serious allergic reaction.

Very common (may affect more than 1 in 10 people)

Hot flushes, pain and redness at the injection site. Injection site reactions are more common with the initial dose and less common with the maintenance dose.

Common (may affect up to 1 in 10 people)

Swelling, nodules and hardening at the injection site
Chills, fever or flu-like symptoms after injection
Sleep disturbances, fatigue, dizziness, headache
Weight gain, nausea, diarrhoea, elevated levels of certain liver enzymes
Excessive sweating (including night sweats), rash
Anaemia
Musculoskeletal pain and disorders
Testicular volume reduction, breast swelling, impotence

Uncommon (may affect up to 1 in 100 people)

Loss of sexual desire, testicular pain, pelvic pain, ejaculatory failure, genital irritation, breast pain
Depression, psychiatric disturbances
Skin redness, hair loss, skin nodules, numbness
Allergic reactions, urticaria, itching
Decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar levels/diabetes mellitus, increased cholesterol, changes in blood calcium levels, weight loss
Increased blood pressure, changes in heart rate, changes in ECG (prolongation of the QT interval), palpitations, dyspnoea, peripheral oedema
Muscle weakness, muscle spasms, joint swelling/stiffness, osteoporosis/osteopenia, joint pain
Frequent need to urinate, urgency to urinate, difficulty or pain when urinating, nocturia, impaired kidney function, incontinence
Blurred vision
Injection site discomfort including decreased blood pressure and heart rate (vasovagal reaction)
Malaise

Rare (may affect up to 1 in 1,000 people)

Febrile neutropenia (very low white blood cell count in combination with fever), heart attack, heart failure
Unexplained muscle pain or cramps, tenderness or weakness. Muscle problems may be severe, including muscle rupture leading to kidney damage.

Very rare (may affect up to 1 in 10,000 people)

Infection, abscess and necrosis at the injection site

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FIRMAGON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vials, syringes, and
carton.
The expiry date refers to the last day of that month.
This medicine does not require special storage precautions.
After reconstitution
This medicine is stable for 2 hours at 25°C.
Due to the risk of microbial contamination, this medicine should be used immediately.
If not used immediately, the responsibility for use of this medicine lies with the user.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What FIRMAGON Contains

The active substance is degarelix. Each vial contains 120 mg of degarelix (as acetate). After reconstitution, 1 ml of the reconstituted solution contains 40 mg of degarelix.
The other ingredient in the powder is mannitol (E421).
The solvent is water for injections.

What FIRMAGON Looks Like and Contents of the Pack
FIRMAGON is a powder and solvent for injectable solution. The powder is white to almost white in appearance.
The solvent is a clear, colourless solution.
The pack containing 2 trays includes:
2 vials of powder containing 120 mg of degarelix and 2 pre-filled syringes containing 3 ml of solvent,
2 plungers, 2 vial adapters, and 2 injection needles.

Marketing Authorization Holder
Ferring Pharmaceuticals A/S
Amager Strandvej 4052770 Kastrup
Denmark
Tel.: +45 8833 8834

Manufacturer
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

For any information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder: