Prospecto: information for the user

FIRMAGON 80mgpowder and solvent for injectable solution

degarelix

Read this prospect carefully before starting to use this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• Ifyouexperienceadverse effects, consult your doctor or pharmacist,eveniftheyarenotlistedin this prospect.See section 4.

1.What is FIRMAGON and what it is used for

2.What you need to know beforestartingtouse FIRMAGON

3.How to use FIRMAGON

4.Adverse effects

5.Storage of FIRMAGON

6.Contents of the package and additional information

FIRMAGON contains degarelix.

Degarelix is a synthetic hormone blocker used for the treatment of cancer and for the treatment of high-risk prostate cancer before radiation therapy and in combination with radiation therapy in adult male patients. Degarelix simulates the effects of a natural hormone (the gonadotropin-releasing hormone, GnRH), by direct blockade of its effects. For this reason, degarelix rapidly reduces levels of the male hormone called testosterone, which is responsible for stimulating prostate cancer.

Do not use FIRMAGON

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor if you have:

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

Children and adolescents

Do not administer this medication to children or adolescents.

Use of FIRMAGON with other medications

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

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Driving and operating machinery

Fatigue and dizziness are common side effects that may affect your ability to drive and operate machinery. These side effects may be due to treatment or be related to the underlying disease.

Generally, a nurse or doctor will administer this medication by injection.

The recommended starting dose is two consecutive injections of 120 mg. After that, a monthly dose of 80 mg will be injected. The liquid 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 the blood (intravenous injection). Special care must be taken to avoid accidental injection into a vein. It is common to vary the injection site to different points on the abdominal wall.

If you forgot to use FIRMAGON

If you think you have forgotten to administer your monthly dose of FIRMAGON, ask your doctor.

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

Like all medicines, FIRMAGON can cause side effects, although not everyone will experience them.

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

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

Hot flashes, adverse reactions at the injection site, and flushing. Adverse reactions at the injection site occur more frequently with the initial dose, being less frequent when administering the maintenance dose.

Common(may affect up to 1 in 10 patients)

• Swelling, nodule, and hardness at the injection site
• Chills, fever, or flu-like symptoms after the injection
• Difficulty sleeping, fatigue, dizziness, headache
• Weight gain, nausea, diarrhea, increased levels of certain liver enzymes
• Excessive sweating (including nocturnal sweating), skin rash
• Anemia
• Musculoskeletal pain and discomfort
• Testicular shrinkage, chest inflammation, impotence

Uncommon(may affect up to 1 in 100 patients)

• Loss of sexual desire, testicular pain, pelvic pain, ejaculation interruption, genital irritation, chest pain
• Depression, mental deterioration
• Skin discoloration, hair loss, skin nodules, numbness
• Allergic reactions, urticaria, itching
• Decreased appetite, constipation, vomiting, dry mouth, abdominal pain and discomfort, increased blood sugar/diabetes mellitus, increased cholesterol, changes in calcium levels in the blood, weight loss
• High blood pressure, changes in heart rhythm, changes in electrocardiogram (prolongation QT), abnormal heart pumping sensation, shortness of breath, peripheral edema
• Muscle weakness, muscle spasms, joint swelling/numbness, osteoporosis/osteopenia, joint pain
• Frequent urination, urinary urgency (imperative need to urinate), difficulty or pain urinating, nocturnal urination, renal function alteration, 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 patients)

• Fever neutropenia (very low white blood cell count in combination with fever), heart attack, heart failure.
• Unexplained muscle pain or cramps, sensitivity or weakness. Muscle problems can be severe, including muscle degradation that can damage the kidneys.

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

• Infection at the injection site, abscess, and necrosis

Reporting of side effects

If you experienceany type ofside effect, consultyour doctor orpharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational reporting systemincluded in theAnexo V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use FIRMAGON after the expiration date that appears on the vials, syringes, and packaging. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions..

After reconstitution

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

Due to microbiological contamination risks, the medication must be used immediately. If not used immediately, the use of this medication will be the responsibility of the user.

Medications should not be disposed of through drains or trash..Ask your pharmacisthow to dispose of the packaging andthe medications thatyouno longerneed.This will help protect the environment.

Composition of FIRMAGON

• The active ingredient is degarelix. Each vial contains 80mg of degarelix (as acetate). After reconstitution, 1ml of reconstituted solution contains 20mg of degarelix
• The other component of the powder is mannitol (E 421).
• The solvent is water for injection.

Appearance of FIRMAGON and contents of the pack

FIRMAGON is a powder and solvent for injection solution. The powder is off-white to white in color. 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 80mg of degarelix and 1 pre-filled syringe containing 4.2ml of solvent.

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

Pack size of 3 trays containing:

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

3 plunger rods, 3 vial adapters, and 3 injection needles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Responsible Person for Manufacturing

Marketing Authorization Holder:

Ferring Pharmaceuticals A/S

Amager Strandvej 405

2770 Kastrup

Denmark

Tel. +45 8833 8834

Responsible Person for Manufacturing:

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

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

Last update of thissummary of product characteristics:

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

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This information is intended solely for healthcare professionals:

Instructions for correct use.

NOTE:

•DO NOT SHAKE THE VIALS

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 reconstituted solution has been demonstrated for 2 hours at25ºC. From a microbiological point of view, unless the reconstitution method poses a risk of contamination, the product should be used immediately. If not used immediately, the conditions and duration of use will be the responsibility of the user.