FIRMAGON 80 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

FIRMAGON 80mgpowder 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 or pharmacist.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What is FIRMAGON and what is it used for
2. What you need to know before you use FIRMAGON
3. How to use FIRMAGON
4. Possible side effects
5. Storage of FIRMAGON
6. Contents of the pack and other information

1. What is FIRMAGON and what is it used for

FIRMAGON contains degarelix.

Degarelix is a synthetic hormonal blocker that is used to treat cancer and to treat high-risk prostate cancer before radiotherapy and in combination with radiotherapy in adult male patients. Degarelix mimics the effects of a natural hormone (gonadotropin-releasing hormone, GnRH) by directly blocking its effects. For this reason, degarelix rapidly reduces the levels of the male hormone called testosterone, which is responsible for stimulating prostate cancer.

2. What you need to know before you use FIRMAGON

Do not use FIRMAGON

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Tell your doctor if you have:

• Any cardiovascular condition or heart rhythm problems (arrhythmias) or if you are being treated with medicines to correct this condition. The risk of heart rhythm problems may be increased with the use of FIRMAGON.
• Diabetes mellitus. Worsening or onset of diabetes may occur. If you have diabetes, you may need to check your blood sugar levels more frequently.
• Liver disease. You may need to have your liver function monitored.
• Kidney disease. The use of Firmagon has not been investigated in patients with severe kidney disease.
• Osteoporosis or any condition that affects bone density. Reduced testosterone levels can cause a reduction in bone calcium (thinning of the bone).
• Severe hypersensitivity. The use of Firmagon has not been investigated in patients with severe hypersensitivity reactions.

Children and adolescents

Do not give this medicine to children or adolescents.

Using FIRMAGON with other medicines

FIRMAGON may interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone, and sotalol) or with medicines that affect heart rhythm (e.g. methadone (used for pain relief and as part of drug detoxification), moxifloxacin (an antibiotic), antipsychotics).

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Driving and using machines

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

3. How to use FIRMAGON

Normally, the injection of this medicine will be given by a nurse or doctor.

The recommended starting dose is two consecutive injections of 120 mg. After that, you will be given a monthly dose of 80 mg. The liquid that is injected forms a gel from which degarelix is released over a month.

FIRMAGON MUST ONLY be injected under the skin (subcutaneous injection). FIRMAGON MUST NOT be administered into a vein (intravenous injection). Special care must be taken to avoid accidental injection into a vein. It is usual to vary the injection site in different points of the abdominal wall.

If you miss a dose of FIRMAGON

If you think you have missed your monthly dose of FIRMAGON, ask your doctor.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

A very severe allergic reaction to this medicine is rare. Tell your doctor immediately if you develop a severe skin rash, itching, or difficulty breathing. This could be a symptom of a severe allergic reaction.

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

Hot flushes, injection site reactions, and redness. Injection site reactions occur more frequently with the starting dose and are less frequent with the maintenance dose.

Common (may affect up to 1 in 10 people)

• Swelling, nodule, and hardness at the injection site
• Chills, fever, or flu-like symptoms after injection
• Difficulty sleeping, fatigue, dizziness, headache
• Weight gain, nausea, diarrhea, increase in certain liver enzymes
• Excessive sweating (including night sweats), skin rash
• Anemia
• Musculoskeletal pain and discomfort
• Reduced testicle size, breast tenderness, impotence.

Uncommon (may affect up to 1 in 100 people)

• Loss of sexual desire, testicular pain, pelvic pain, interruption of ejaculation, genital irritation, chest pain
• Depression, mental impairment
• Skin discoloration, hair loss, skin nodules, 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 levels, weight loss
• High blood pressure, changes in heart rhythm, changes in electrocardiogram (QT prolongation), abnormal heart pumping sensation, shortness of breath, peripheral edema
• Muscle weakness, muscle spasms, swelling/numbness of the joints, osteoporosis/osteopenia, joint pain
• Frequent need to urinate, urgent need to urinate (strong need to urinate), difficulty or pain when urinating, need to urinate at night, kidney function changes, incontinence
• Blurred vision
• Injection site reaction including decreased blood pressure and heart rate (vasovagal reaction)
• Discomfort

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

• Febrile neutropenia (very low number of white blood cells in the blood in combination with fever), heart attack, heart failure.
• Unexplained muscle pain or cramps, sensitivity, or weakness. Muscle problems can be serious, including muscle breakdown that can damage the kidneys.

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

• Injection site infection, abscess, and necrosis

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of FIRMAGON

Keep this medicine out of the sight and reach of children.

Do not use FIRMAGON after the expiry date which is stated on the vials, syringes, and carton. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

After reconstitution

This medicine is stable for 2 hours at 25°C.

Due to the risk of microbiological contamination, the medicine should be used immediately. If not used immediately, the use of this medicine will be the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 reconstituted solution contains 20 mg of 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 and solvent for solution for injection. The powder is white to off-white. The solvent is a clear and colorless solution.

Firmagon is available in 2 pack sizes.

Pack size of 1 tray containing:

1 vial of powder containing 80 mg of degarelix and 1 pre-filled syringe containing 4.2 ml of solvent.

1 plunger, 1 vial adapter, and 1 injection needle.

Pack size of 3 trays containing:

3 vials of powder containing 80 mg of degarelix and 3 pre-filled syringes containing 4.2 ml of solvent.

3 plungers, 3 vial adapters, and 3 injection needles.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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

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This information is intended only for healthcare professionals:

Instructions for correct use.

NOTE:

• THE VIALS MUST NOT BE SHAKEN

The pack contains a vial of powder and a pre-filled syringe with solvent that must be prepared for subcutaneous injection.

• The chemical and physical stability of the preparation has been demonstrated for 2 hours at 25°C. From a microbiological point of view, unless the method of reconstitution implies a risk of contamination, the product should be used immediately. If not used immediately, the conditions and time of use will be the responsibility of the user.