Firmagon

The usual starting dose of Firmagon (Degarelix) is 240 mg injected subcutaneously (under the skin) as 2 injections of 120 mg each. After this initial dose, the recommended dose is 80 mg injected subcutaneously every month.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Treating the symptoms of cancer that is dependent on hormones for growth requires a constant level of testosterone suppression. To achieve this, it is important Firmagon (Degarelix) be given exactly as recommended by your doctor. If you miss an appointment to receive Firmagon (Degarelix), contact your doctor as soon as possible to reschedule your appointment.

Store Firmagon (Degarelix) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

80 mg vial
Each single-use vial contains 80 mg of Firmagon (Degarelix) powder as Firmagon (Degarelix) acetate. Nonmedicinal ingredients: mannitol, pre-filled syringe containing sterile water for injection.

120 mg vial
Each single-use vial contains 120 mg of Firmagon (Degarelix) powder as Firmagon (Degarelix) acetate. Nonmedicinal ingredients: mannitol, pre-filled syringe containing sterile water for injection.

Do not take Firmagon (Degarelix) if you are allergic to Firmagon (Degarelix) or any ingredients of the medication.

This medication is not intended for use by women or children.

There may be an interaction between Firmagon (Degarelix) and any of the following:

• Alfuzosin
• Amiodarone
• anti-emetic medications (serotonin antagonists; e.g., Granisetron, Ondansetron)
• anti-psychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, olanzepine, Quetiapine, Risperidone)
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Buprenorphine
• certain protein kinase inhibitors (e.g., Dasatinib, Nilotinib, Pazopanib)
• chloral hydrate
• chloroquine
• Disopyramide
• dofetilide
• Domperidone
• Dronedarone
• droperidol
• Flecainide
• formoterol
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• Maprotiline
• Mefloquine
• Methadone
• Primaquine
• procainamide

• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rilpivirine
• ritonavir
• Romidepsin
• saquinavir
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• Sotalol
• Tacrolimus
• Tetrabenazine
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Vardenafil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Firmagon (Degarelix). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Firmagon (Degarelix).

Abnormal heart rhythms: Firmagon (Degarelix) can cause abnormal heart rhythms. Certain medications can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with Firmagon (Degarelix). You are more at risk for this type of abnormal heart rhythm and its complications if you:

• are older than 65 years of age
• have a family history of sudden cardiac death
• have a history of heart disease or abnormal heart rhythms
• have a slow heart rate
• have congenital prolongation of the QT interval
• have Diabetes
• have had a Stroke
• have low potassium, magnesium, or calcium levels
• have nutritional deficiencies

If you have heart disease and abnormal heart rhythms, or are taking certain medications, discuss with your doctor how Firmagon (Degarelix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Firmagon (Degarelix), and whether any special monitoring is needed.

Anemia: Reducing testosterone production can cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Diabetes: Firmagon (Degarelix) may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Firmagon (Degarelix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Firmagon (Degarelix), and whether any special monitoring is needed.

Drowsiness/reduced alertness: Firmagon (Degarelix) may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how Firmagon (Degarelix) affects you.

Heart disease: Firmagon (Degarelix) may increase the risk of developing high blood pressure, heart attack or other heart disease. If you have heart disease or have been told you are at risk of developing heart disease, discuss with your doctor how Firmagon (Degarelix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause a decrease in the effectiveness of Firmagon (Degarelix). If you have liver problems, discuss with your doctor how Firmagon (Degarelix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Firmagon (Degarelix).

Osteoporosis: Firmagon (Degarelix) may cause bone to become thinner and break more easily. If you have osteoporosis or are at risk for developing osteoporosis, discuss with your doctor how Firmagon (Degarelix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Firmagon (Degarelix), and whether any special monitoring is needed.

Pregnancy: Firmagon (Degarelix) is not intended for use by women.

Breast-feeding: Firmagon (Degarelix) is not intended for use by women.

Children: Firmagon (Degarelix) is not intended for use for children. The safety and effectiveness of using Firmagon (Degarelix) have not been established for children.