Firmagon: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

FIRMAGON (degarelix) is used in the treatment of patients with advanced prostate cancer.

What it does:

FIRMAGON is a selective gonadotropin-releasing hormone (GnRH) receptor antagonist. FIRMAGON works by blocking the release of gonadotropins from the pituitary gland to reduce the level of the male hormone, testosterone.

When it should not be used:

FIRMAGON should not be used:

• if you are allergic (hypersensitive) to degarelix acetate or any of the other ingredients of FIRMAGON

• in women who are or may become pregnant

• in children

What the medicinal ingredient is:

The medicinal ingredient is degarelix acetate.

What the important nonmedicinal ingredients are:

FIRMAGON vial: mannitol.

Solvent: Prefilled Syringe (sterile water for injectionUSP).

What dosage forms it comes in:

FIRMAGON is a powder that is mixed with sterile water to form a solution for injection. The powder is white to off-white. The solvent is a clear, colorless solution.

The starting dose pack contains: 2 vials of powder, each vial containing 120 mg of degarelix, and 2 pre-filled syringes with 3 ml of solvent,2 plunger rods, 2 vial adapters , 2 injection needles.

The maintenance dose pack contains: 1 vial of powder containing 80 mg of degarelix and 1 pre-filled syringe with 4.2 ml of solvent. 1 plunger rod, 1 vial adapter ,1 injection needle.

WARNINGS AND PRECAUTIONS

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.

INTERACTIONS WITH THIS MEDICATION

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)

FIRMAGON should be prescribed by a doctor experienced in the use of hormonal therapy in prostate cancer and administered by a healthcare professional.

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)
• 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.

PROPER USE OF THIS MEDICATION

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.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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.

Uncommom 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.

Tell your doctor if any side effect gets serious, or if you notice any side effect not listed in this leaflet.

This is not a complete list of side effects. For any unexpected effects while taking FIRMAGON, contact your doctor or pharmacist.

HOW TO STORE IT

Store at 25°C (between 15-30°C).

As with all prescription drugs, this medicine should be kept out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be found by contacting the sponsor, Ferring Inc., at: 1-866-384-1314

March 18, 2016