Firmagon 120mg Injection

FERRING PHARMACEUTICALS

FIRMAGON^® 120mg

Powder and solvent for solution for injection

degarelix

FIRMAGON contains degarelix.

Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer and for the treatment of high-risk prostate cancer prior to radiotherapy and in combination with radiotherapy in adult male patients. 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.

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

The recommended starting dose is two consecutive injections of 120 mg. After that, you will receive a monthly 80 mg injection. The injected liquid forms a gel from which degarelix is released 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 have any further questions on the use of this medicine, ask your doctor.

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

A very serious allergic reaction to this medicine is rare. Seek medical advice straight away if you develop a severe rash, itching or shortness of breath or difficulty breathing. These could be symptoms of a severe allergic reaction.

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

Hot flushes, injection site pain and redness. Side effects at the injection site are most common with the starting dose and less common with the maintenance dose.

Common (may affect up to 1 in 10 people)

• 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 (may affect up to 1 in 100 people)

• 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

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

• febrile neutropenia (very low number of white blood cell in combination with fever), heart attack, heart failure
• unexplained muscular pain or cramps, tenderness, or weakness. The muscle problems can be serious, including muscle breakdown resulting in kidney damage.

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

injection site infection, abscess and necrosis

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

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

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 microbial contamination, this medicine should be used immediately. If not used immediately, the use of this medicine are the responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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