Firmagon (Degarelix Acetate)

Usual dose:

The starting dose: 240 mg given as two injections of 120 mg each.

The maintenance dose: 80 mg given once a month. The maintenance dose is usually given one month after the starting dose.

The injected liquid forms a gel from which a continuous release of FIRMAGON takes place over a period of one month.

How is FIRMAGON used?

The powder and solvent are mixed and injected by your doctor or a nurse in your abdominal region.

FIRMAGON must be injected under the skin (subcutaneously) ONLY. The site of injection is likely to vary within the abdominal region.

Make sure your injection site is free of any pressure from belts, waistbands or other types of clothing.

Always remind your doctor or nurse to set up an appointment for your next injection.

Monitoring and testing while taking FIRMAGON:

You will be checked regularly by your doctor while you are taking FIRMAGON, to monitor side effects and to check your response to therapy. Blood tests may be ordered by your doctor.

Overdose:

If you think you were given more FIRMAGON than required, talk to your doctor or nurse, or contact poison control centre immediately.

Missed dose:

If you missed an injection at the usual time and/or if you believe your monthly dose of FIRMAGON has been forgotten, talk to your doctor or nurse.

Common side effects with FIRMAGON include injection site reactions (e.g. pain, redness, node or hardness, and/or swelling), hot flashes, weight gain, increase in blood liver enzymes, high blood pressure, back pain, increase in blood cholesterol, nausea, tiredness, chills, constipation, dizziness and anemia.

Injection site reactions have occurred, usually with the first dose and become less with subsequent doses. These reactions are usually mild and resolve after a few days.

Less common side effects include: weakness, fever or flu-like illness, sweating, bone pain, headache, trouble sleeping. Frequent passage of small amount of urine and urge to urinate.

Uncommon side effects include loss of sex drive, impotence, decrease in testicular size, breast swelling and diarrhea.

FIRMAGON may induce thinning of the bone (osteoporosis), and/or a change in heart rhythm (QT prolongation). QT prolongation symptoms include sensation of skipped heart beats or rapid or forceful beats, shortness of breath, chest discomfort and fainting.

Contact your doctor immediately if you experience any of the following symptoms: severe back pain, severe hot flashes, heavy sweating, severe pain in the chest or abdomen, abnormal swelling, weakness, persistent nausea or vomiting, or rapid heart beat.

Serious Warnings and Precautions

FIRMAGON should be prescribed by a doctor experienced in the use of hormonal therapy in prostate cancer and administered (given) under his/her supervision.

FIRMAGON has not been studied in patients with severe liver impairment or in patients with severe kidney impairment.

Possible serious side effects of FIRMAGON include:

• QT prolongation (changes in heart rhythm)
• Osteoporosis (thinning of the bone)

BEFORE you use FIRMAGON talk to your doctor or pharmacist if you:

• are taking medicines that affect the heart rhythm
• have any heart problems such as abnormal heartbeat (arrhythmias)
• have problems with the balance of your body salts or electrolytes, such as sodium, potassium, calcium and magnesium
• have kidney or liver problems
• have diabetes mellitus (sugar diabetes). Worsening or onset of diabetes may occur. If you have diabetes, you may have to measure blood glucose more frequently
• have bone problems. The use of FIRMAGON may result in loss of mineral from bone, some of which may not be reversible
• have anemia (low red blood cell count)

FIRMAGON may cause the body to produce anti-degarelix antibody. There is no indication that this impacts the safety and efficacy of FIRMAGON treatment.

FIRMAGON may cause dizziness. Do not drive a car or operate machinery until you know how the drug affects you.

FIRMAGON is not indicated for use in women and children.

Tell your doctor and pharmacist if you are taking or have taken any medicines for your heart such as:

• antiarrhythmics (e.g. quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, ibutilide, flecainide, propafenone)

Or other medicines which can have an effect on heart rhythm such as:

• antipsychotics (e.g. chlorpromazine)
• antidepressants (e.g. amitriptyline, nortriptyline)
• opioids (e.g. methadone)
• macrolide antibiotics and analogues (e.g. erythromycin, clarithromycin, azithromycin)
• quinolone antibiotics (e.g. moxifloxacin)
• pentamidine
• antimalarials (e.g. quinine)
• azole antifungals
• cisapride
• 5-hydroxytryptamine (5-HT3) receptor antagonists (e.g. ondansetron)
• beta-2 adrenoceptor agonists (e.g. salbutamol)

Tell your doctor if you are taking or have recently taken, or are planning to take any other medicines, including non-prescription drugs such as vitamins and herbal supplements.