Consumer Information for: FIRMAGON

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


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 non-medicinal ingredients are

FIRMAGON vial: mannitol. Solvent: Prefilled Syringe (sterile water for injectionUSP).

What dosage form it comes in

FIRMAGON is a powder that is mixed with sterile water to form a solution for injection. The powder is white to offwhite. 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

FIRMAGON should be prescribed by a doctor experienced in the use of hormonal therapy in prostate cancer and administered (given) 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)

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)
  • 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 nonprescription 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 flulike 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.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Common
injection site pain, redness, swelling, node and hardness ✔    
hot flashes ✔    
weight gain ✔    
back pain ✔    
nausea ✔    
tiredness ✔    
constipation ✔    
chills ✔    
dizziness ✔    
weakness ✔    
fever or flulike illness ✔    
sweating ✔    
low red blood cell count   ✔  
Less Common
bone pain ✔    
headache ✔    
trouble sleeping ✔    
frequent urination ✔    
urge to urinate ✔    
loss of sex drive ✔    
impotence ✔    
decrease in testicular size ✔    
Uncommon
breast swelling ✔    
diarrhea ✔    
abnormal swelling   ✔  
severe pain in chest or abdomen   ✔  

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

How to store

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 side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

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

This leaflet was prepared by Ferring Inc.

March 18, 2016

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