Firmagon ® 80 mg/120 mg Solution

FIRMAGON ® contains degarelix. Degarelix is a synthetic hormone blocker used in the treatment of prostate cancer. FIRMAGON ® reduces the level of the male hormone, testosterone that stimulates the prostate cancer.

FIRMAGON ® should not be administered to you:

• if you are hypersensitive (allergic) to degarelix or to any of the other ingredients of FIRMAGON ® (listed in section 6),
• if you are a woman,
• if you are a child,
• if you are pregnant,
• if you have a corrected QT (QT C ) duration of > 450 msec, for instance, if you are born with a prolonged QT interval,
• if you are currently taking or recently have taken medicine used to treat heart rhythm problems such as procainamide, quinidine, amiodarone and sotalol.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• if you have any cardiovascular conditions or heart rhythm problems (dysrhythmias). The risk of heart rhythm problems may be increased when using FIRMAGON ®,
• if you have liver disease. Liver function may need to be monitored,
• if you have kidney disease. Use of FIRMAGON ® has not been investigated in patients with severe kidney disease,
• if you have a history of severe hypersensitivity, which includes severe allergic reaction characterized by raised, red, and itchy bumps and swelling of the face and eyes or severe untreated asthma,
• if you have bone density problems, such as osteoporosis or any condition that affects the strength of your bones. Reduced level of testosterone may cause a reduction in bone calcium (thinning of bones),
• if you have diabetes mellitus (high blood sugar levels). Worsening or onset of diabetes may occur. If you have diabetes, you may have to measure your blood glucose more frequently.

Children and adolescents

Do not give FIRMAGON ® to children or adolescents.

Other medicines and FIRMAGON ®

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) FIRMAGON ® may prolong the QTc interval therefore, FIRMAGON ® should not be used with medicine known to prolong the QTc interval, such as medicine used to regulate your heart rhythm (e.g., quinidine, procainamide, amiodarone, and sotalol), methadone (used for pain relief), moxifloxacin (an antibiotic) or antipsychotics.

FIRMAGON ® with food and drink

There is no special precaution for food and drink intake while using FIRMAGON ®.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. FIRMAGON ® must not be used in women. FIRMAGON ® may affect male fertility as long as the level of the male hormone, testosterone stay low.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself FIRMAGON ®. It will be given to you by a person who is qualified to do so. The powder and solvent are mixed and injected within 1 hour after mixing, by your doctor or a nurse, in your abdominal region. Instruction for proper use of the medicine is included in section 6 of this leaflet. The appropriate dose will be injected under the skin (subcutaneously). The site of injection is likely to vary. The injected liquid forms a depot from which a continuous release of degarelix takes place over a period of one month. The usual dose is as follow:

• Initial dose: Two injections of 120 mg are given as a first dose.
• Maintenance dose: For all subsequent doses one injection of 80 mg is given monthly.

Your doctor will tell you how long your treatment with FIRMAGON ® will last. If you have the impression that the effect of FIRMAGON ® is too strong or too weak, talk to your doctor or pharmacist.

If you received more FIRMAGON ® than you should

Since a health care provider will administer FIRMAGON ®, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forgot to use FIRMAGON ®

Since a health care provider will administer FIRMAGON ®, it is unlikely that the dose will be missed.

FIRMAGON ® can have side effects. Not all side effects reported for FIRMAGON ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using FIRMAGON ®, please consult your health care provider for advice. If any of the following happens, stop using FIRMAGON ® and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting. These are all very serious side effects. If you have them, you may have a serious reaction to FIRMAGON ®. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• heart attack (chest discomfort, pain or discomfort in other areas of the upper body, and shortness of breath),
• heart failure (shortness of breath, swelling of the legs, ankles, feet, abdomen, tiredness and weakness, change in your heartbeat with persistent coughing or wheezing),
• neutropenic fever (very low number of white blood cell in combination with fever accompanied by chills, shaking and profuse sweating, weak and tired, pain and headaches). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Very common side effects:

• hot flushes,
• injection site pain, redness, swelling, node and hardness *, * Side effects at the injection site are very common with the starting dose and less common with the maintenance dose.

Common side effects:

• reduced number of red blood cells (anaemia),
• increased weight,
• trouble sleeping, dizziness, headache,
• nausea, diarrhoea,
• elevated levels of some liver enzymes (transaminases),
• excessive sweating, night sweats,
• discomfort or ache in the muscles, bones, or joints,
• impotence, reduced size of testicles, breast swelling,
• chills, fever,
• weakness, tiredness,
• influenza-like illness.

Uncommon side effects:

• allergic reactions,
• increase blood sugar, increase cholesterol, decreased weight, changes in the blood calcium, decreased appetite,
• loss of sexual desire,
• depression, mental impairment,
• reduced sensitivity to touch, temperature, or pain in a specific area of the body,
• blurred vision,
• changes in the way your heart beats, changes in ECG (QT-prolongation),
• high blood pressure,
• discomfort at injection including decreased blood pressure and heart rate (vasovagal reaction),
• difficulty or discomfort in breathing,
• dry mouth,
• abdominal pain and discomfort, constipation, vomiting,
• hives,
• locally changed skin colour, loss of hair,
• osteoporosis/osteopenia, pain in the joint, muscular weakness, muscle spasms, joint swelling/stiffness,
• frequent urination, urinary urgency (must hurry to pass urine), difficult or painful urination, urination at night, impaired renal function, incontinence (inability to control urination or defecation),
• testicular pain, pelvic pain or breast pain, genital irritation, ejaculation failure,
• malaise (a feeling of discomfort, unease, or weakness).

Rare side effects:

• unexplained muscular pain or cramps, tenderness, or weakness. The muscle problems can be serious, including muscle breakdown resulting in kidney damage.

Very rare side effects:

• serious injection site reactions such as injection site infection, injection site abscess or injection site necrosis that could require surgical treatment/drainage.

If you notice any side effects not mentioned in this leaflet, please inform you doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of FIRMAGON ®.

Store all medicine out of reach of children.

Store at or below 25 ºC.

FIRMAGON ® should not be frozen.

Do not use FIRMAGON ® after the expiry date printed on the vials and outer packaging. The expiry date refers to the last day of that month.

After reconstitution the product is stable for 2 hours at 25 ºC. Due to the risk of microbial contamination, this medicine should be injected immediately.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).