Degarelix

What is Degarelix?

• Degarelix (Firmagon) is a gonadotropin releasing hormone (GnRH) receptor antagonist that effectively blocks androgen production and is used to treat advanced prostate cancer.

Degarelix

What are the uses of this medicine?

• Degarelix (Firmagon) is a prescription medicine used in the treatment of advanced prostate cancer.

How does this medicine work?

• Degarelix (deg" a rel' ix) is synthetic decapeptide antagonist of gonadotropin releasing hormone (GnRH) that blocks GnRH stimulation of luteinizing hormone (LH) and follicular stimulating hormone (FSH) production by the pituitary gland, thereby decreasing the synthesis of testosterone by the testes in men and estrogen by the ovaries in women.
• Degarelix has been found to be palliative in advanced prostate cancer with equivalent efficacy to the GnRH agonists, such as leuprolide and goserelin.
• Because degarelix is an antagonist of GnRH, it does not cause the initial increase in testosterone synthesis that occurs with use of GnRH agonists.
• Degarelix binds to gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland.
• This causes the testicles to stop making testosterone.
• Degarelix may stop the growth of cancer cells that need testosterone to grow.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to degarelix or any ingredient in FIRMAGON.

What drug interactions can this medicine cause?

• No drug-drug interaction studies were conducted.

Is this medicine FDA approved?

• Degarelix was approved for use in the United States in 2008, and current indications are limited to therapy of advanced prostate cancer.

How should this medicine be used?

Recommended dosage:

• Starting Dosage: 240 mg given as two injections of 120 mg each.
• Maintenance Dosage: 80 mg administered as a single injection every 28 days.

Administration:

• You will receive an injection of FIRMAGON from your healthcare provider.
• The injection site will always be in the stomach (abdominal area).
• The injection site will change within the stomach area each time you receive a dose of FIRMAGON.
• Two injections are given as a first dose.
• The following monthly doses are one injection.
• Do not rub or scratch the injection site.
• Make sure your injection site is free of any pressure from belts, waistbands or other types of clothing.
• Always set up an appointment for your next injection.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As injection:

• FIRMAGON (240 mg)
• FIRMAGON (80 mg)

This medicine is available in fallowing brand namesː

• FIRMAGON

What side effects can this medication cause?

The most common side effects of this medicine include:

• Injection site pain, redness, and swelling
• hot flashes
• weight gain
• increase in some liver enzymes

Other side effects include decreased sex drive and erectile function problems.

FIRMAGON can cause serious side effects, including:

• Serious allergic reactions
• Disorder of the heart's electrical activity

What special precautions should I follow?

• Hypersensitivity reactions, including anaphylaxis, urticaria and angioedema, have been reported post-marketing with FIRMAGON. Discontinue FIRMAGON if a severe hypersensitivity reaction occurs and manage as clinically indicated.
• Androgen deprivation therapy may prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
• FIRMAGON results in suppression of the pituitary gonadal system. The therapeutic effect of FIRMAGON should be monitored by measuring serum concentrations of prostate-specific antigen (PSA) periodically. If PSA increases, serum concentrations of testosterone should be measured.
• Based on findings in animal studies, FIRMAGON can cause fetal harm and loss of pregnancy when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
• Degarelix therapy is associated with serum enzyme elevations during therapy, but has yet to be linked to instances of clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• There have been no reports of overdose with FIRMAGON.

Management of overdosage:

• In the case of overdose, however, discontinue FIRMAGON, treat the patient symptomatically, and institute supportive measures.

Can this medicine be used in pregnancy?

• The safety and efficacy of FIRMAGON have not been established in women.
• Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: degarelix (as acetate)
• Inactive ingredient: mannitol

Who manufactures and distributes this medicine?

MANUFACTURED FOR:

• FERRING PHARMACEUTICALS INC., PARSIPPANY, NJ
• Manufactured in Germany

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

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• Dailymed label info on Degarelix
• FDA Degarelix

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