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Description

Degarelix is used in men to treat advanced prostate cancer. Degarelix is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist. It helps treat prostate cancer by lowering the amount of testosterone hormone in the blood. In some patients, testosterone will cause prostate cancer to grow larger.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of degarelix in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of degarelix in the elderly.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Heart rhythm problems (e.g., prolonged QT interval) or
• Mineral imbalance (low calcium, magnesium, potassium, or sodium in the blood)—May increase risk for more serious side effects.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects of this medicine may be increased because of slower removal from the body.

Proper Use

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under your skin in the stomach area.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine can cause a change in heart rhythm called prolongation of the QT interval. This condition may change the way your heart beats (faster or slower) and can cause chest pain, dizziness, fainting, or shortness of breath. Contact your doctor right away if you have any of these symptoms or any questions.

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this ask your doctor.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Back pain
• Blurred vision
• Dizziness
• Fever
• Flushing or redness of the skin
• Hard lump
• Headache
• Nervousness
• Pain
• Pounding in the ears
• Slow or fast heartbeat
• Small lumps under the skin
• Swelling
• Unusually warm skin

• Bladder pain
• Bloody or cloudy urine
• Chills
• Decrease in testicle size
• Decreased interest in sexual intercourse
• Difficult, burning, or painful urination
• Difficulty in moving
• Frequent urge to urinate
• Inability to have or keep an erection
• Increased sweating
• Loss in sexual ability, desire, drive, or performance
• Lower back or side pain
• Muscle pain or stiffness
• Pain in the joints

• Chest pain or discomfort
• Fainting
• Irregular heartbeat
• Pounding heartbeat
• Shortness of breath

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty having a bowel movement (stool)
• Feeling of warmth
• Increased weight
• Redness of the face, neck, arms, and occasionally, upper chest
• Sudden sweating
• Unusual tiredness or weakness

• Diarrhea
• Lack or loss of strength
• Nausea
• Night sweats
• Sleeplessness
• Swelling of the breasts or breast soreness
• Trouble sleeping
• Unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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