Degarelix Injection

WHY is this medicine prescribed?

Degarelix injection is used to treat advanced prostate cancer (cancer that begins in the prostate [a male reproductive gland]). Degarelix injection is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. This may slow or stop the spread of prostate cancer cells that need testosterone to grow.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Degarelix injection comes as a powder to be mixed with liquid and injected under the skin in the stomach area, away from the ribs and waistline. It is usually injected once every 28 days by a doctor or nurse in a medical facility.

After you receive a dose of degarelix injection, be sure that your belt or waistband does not put pressure on the place where the medication was injected.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving degarelix injection,

• tell your doctor and pharmacist if you are allergic to degarelix injection, any other medications, or any of the ingredients in degarelix injection. Ask your pharmacist or check the patient information for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you or anyone in your family has or has ever had osteoporosis (condition where bones are thin and more likely to break). Also, tell your doctor if you have or have ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); high or low blood levels of calcium, potassium, magnesium, or sodium in your blood; high blood pressure, or heart, liver, or kidney disease.

• you should know that degarelix injection is intended only for use in adult men. Degarelix is not intended for use in women, especially if they are or may become pregnant. Degarelix injection may harm the fetus. If you receive degarelix injection while you are pregnant, call your doctor immediately. If you are breastfeeding, talk to your doctor before you receive degarelix injection.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of receiving degarelix injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of degarelix injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Degarelix injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, redness, swelling, hardness, or itching in the place where the medication was injected
• hot flashes
• excessive sweating or night sweats
• nausea
• constipation
• diarrhea
• weight gain or loss
• weakness
• dizziness
• headache
• tiredness
• difficulty falling asleep or staying asleep
• enlargement of the breasts
• decreased sexual desire or ability
• back or joint pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• difficulty breathing or swallowing
• rapid, irregular, or pounding heartbeat
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• fluttering feeling in the chest
• fainting
• painful, frequent, or difficult urination; fever; or chills

Degarelix injection may cause your bones to become weaker and more brittle than they were at the beginning of your treatment. Talk to your doctor about the risks of taking this medication.

Degarelix injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to degarelix injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving degarelix injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.