Firmagon 80 mg powder and solvent for solution for injection: detailed information

Brand name Firmagon 80 mg powder and solvent for solution for injection

Form powder and solvent for solution for injection

Active substance / Dosage

DEGARELIX ACETATE · 80 mg

Prescription type Prescription Only Medicine

ATC code

L02B L02BX L02BX02

Registration number 08504001

Manufacturer Ferring Pharmaceuticals A/S

Firmagon 80 mg powder and solvent for solution for injection powder and solvent for solution for injection

Table of Contents

Patient Information Leaflet
Introduction
1. What FIRMAGON is and what it is used for
2. What you need to know before starting to use FIRMAGON
3. How to USE FIRMAGON
4. Possible adverse effects
5. FIRMAGON Storage
6. Contents of the pack and other information

Patient Information Leaflet

Introduction

Patient Information Leaflet

FIRMAGON 80mg powder and solvent for injectable solution

degarelix

Read the entire leaflet carefully before you start using this medicine , because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet Contents:

What FIRMAGON is and what it is used for
What you need to know before using FIRMAGON
How to use FIRMAGON
Possible adverse 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 for the treatment of cancer and for the treatment of high-risk prostate cancer prior to 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 levels of the male hormone called testosterone, which is responsible for stimulating prostate cancer.

2. What you need to know before starting to use FIRMAGON

Do not use FIRMAGON

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

Warnings and precautions

Talk to your doctor if you have:

Any cardiovascular condition or heart rhythm problems (arrhythmias), or if you are being treated with medicines to correct these conditions. The risk of heart rhythm problems may be increased with the use of FIRMAGON.
Diabetes mellitus. Diabetes may worsen or new-onset diabetes may occur. If you have diabetes, you may need to monitor your blood glucose levels more frequently.
Liver disease. You may require monitoring of liver function.
Kidney disease. The use of FIRMAGON has not been studied in patients with severe kidney disease.
Osteoporosis or any condition affecting bone density. Reduced testosterone levels may lead to decreased bone calcium (bone thinning).
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.

Use of FIRMAGON with other medicines

FIRMAGON may interfere with certain medicines used to treat heart rhythm disorders (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 addiction detoxification), moxifloxacin (an antibiotic), antipsychotics).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Driving and using machines

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

3. How to USE FIRMAGON

In general, this medicine will be administered by a nurse or doctor.

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

FIRMAGON MUST ONLY be injected under the skin (subcutaneous injection). FIRMAGON MUST NOT be administered into the bloodstream (intravenous injection). Particular care must be taken to avoid accidental injection into a vein. It is common practice to rotate the injection site to different areas of the abdominal wall.

If you forget to use FIRMAGON

If you think your monthly dose of FIRMAGON has been missed, consult your doctor.

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

4. Possible adverse effects

Like all medicines, FIRMAGON may cause adverse effects, although not everyone experiences them.

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

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

Hot flushes, injection site reactions, and flushing. Adverse reactions at the injection site occur more frequently with the initial dose and are less common 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 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
Decrease in testicle size, breast swelling, impotence

Uncommon (may affect up to 1 in 100 patients):

Loss of sexual desire, testicular pain, pelvic pain, interruption of ejaculation, genital irritation, breast 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 blood calcium levels, weight loss
High blood pressure, changes in heart rate, changes in electrocardiogram (QT prolongation), sensation of abnormal heart pulsation, dyspnea, peripheral edema
Muscle weakness, muscle spasm, joint swelling/numbness, osteoporosis/osteopenia, joint pain
Frequent urge to urinate, urinary urgency (strong need to urinate), difficulty or pain when urinating, need to urinate at night, changes in 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 patients):

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

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

Infection at the injection site, abscess, necrosis

Reporting of adverse effects

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

5. FIRMAGON Storage

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

Do not use FIRMAGON after the expiry date stated on the vials, syringes, and outer packaging. The expiry date refers to the last day of the month indicated.

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 immediate use is not possible, the responsibility for using this medicine lies with the user.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of FIRMAGON

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 component of the powder is mannitol (E 421).
The solvent is water for injections.

Appearance of FIRMAGON and contents of the pack

FIRMAGON is a powder and solvent for injectable solution. The powder is whitish to white in colour. The solvent is a clear, colourless 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 syringe 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 syringe 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

More information about this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgium

Ferring N.V.

Tel/Tel: +32 53 72 92 00

	Remove the cap from the vial adapter. Insert the adapter into the powder vial by pressing the adapter downward until the tip penetrates the rubber stopper and the adapter is securely in place.
Prepare the pre-filled syringe by inserting the plunger rod.
	Remove the cap from the pre-filled syringe. Attach the syringe to the powder vial by twisting it onto the adapter. Transfer all the solvent into the powder vial.
	With the syringe still attached to the adapter, gently swirl the vial slowly until the solution becomes clear and free of powder or undissolved particles. If powder adheres to the vial wall above the liquid surface, the vial may be tilted slightly. Avoid shaking to prevent foam formation. The formation of small circular air bubbles may be acceptable. Reconstitution is typically completed within a few minutes, but may take up to 15 minutes in some cases.
	Turn the vial upside down and align it with the marked line on the injection syringe. Always ensure the exact volume is withdrawn and adjust if air bubbles are present.
Remove the syringe from the vial adapter and attach the subcutaneous injection needle to the syringe.
	Administer as a deep subcutaneous injection. To do this: pinch the skin of the abdomen to form a skin fold and insert the needle deeply at an angle of at least 45 degrees to the base of the skin fold. Inject 4 ml of FIRMAGON 80mg slowly, immediately after reconstitution*
Injections should be administered in areas not subjected to local pressure, for example, not too close to the waistband or ribcage area. Do not inject directly into any blood vessel. Gently pull back on the plunger to check for blood aspiration. If blood appears in the syringe, the medication must not be used. In this case, remove and discard the syringe and needle (reconstitute a new dose for the patient).