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CASODEX (bicalutamide) ®
[pronounced cas-o-dex]
(bicalutamide) Tablets

Patients should be informed that therapy with CASODEX (bicalutamide) and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their physician.

During treatment with CASODEX (bicalutamide) , somnolence has been reported, and those patients who experience this symptom should observe caution when driving or operating machines.

Patients should be informed that diabetes, or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving CASODEX (bicalutamide) in combination with LHRH agonists.

Read the Patient Information that comes with Casodex (bicalutamide) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Casodex (bicalutamide) ?

CASODEX (bicalutamide) is a prescription medicine called an androgen receptor inhibitor, used in combination with lutenizing hormone-releasing hormone (LHRH) medicines to treat stage D2 metatastic prostate cancer. It is not known if Casodex (bicalutamide) is safe and effective in children.

Who should not take Casodex (bicalutamide) ?

Do not take Casodex (bicalutamide) if:

• you are a woman.
• you are allergic to any of the ingredients in Casodex (bicalutamide) . See the end of this leaflet for a complete list of ingredients

What should I tell my healthcare provider before taking Casodex (bicalutamide) ?

Before you take Casodex (bicalutamide) , tell your healthcare provider about all your medical conditions including if you:

• are a woman (see who should not take Casodex (bicalutamide) )
• are pregnant or think you may be pregnant
• have liver problems
• take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner.
• have diabetes (poor blood sugar control has been reported in people taking Casodex (bicalutamide) in combination with LHRH medicines)

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Casodex (bicalutamide) and other medicines may affect each other causing side effects. Casodex (bicalutamide) may affect the way other medicines work, and other medicines may affect how Casodex (bicalutamide) works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I take Casodex (bicalutamide) ?

• Take Casodex (bicalutamide) exactly as prescribed.
• Take Casodex (bicalutamide) at the same time everyday.
• Your treatment with Casodex (bicalutamide) should start at the same time as your treatment with the LHRH medicine
• If you miss a dose do not take an extra dose, take the next dose at your regular time. Do not take 2 doses at the same time.
• Casodex (bicalutamide) can be taken with or without food.
• If you take too much Casodex (bicalutamide) , call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
• Do not stop taking Casodex (bicalutamide) unless your healthcare provider tells you.
• Your healthcare provider may do blood tests while you take Casodex (bicalutamide)
• Your prostate cancer may get worse while taking Casodex (bicalutamide) in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

What should I avoid while taking Casodex (bicalutamide) ?

Driving and operating machinery. Do not drive, operate machinery, or do other dangerous activities until you know how Casodex (bicalutamide) affects you.

What are the possible side effects of Casodex (bicalutamide) ?

Casodex (bicalutamide) can cause serious side effects. Get medical help right away, if you have:

• trouble breathing with or without a cough or fever. Some people who take Casodex (bicalutamide) get an inflammation in the lungs called interstitial lung disease.
• An allergic reaction. Symptoms of an allergic reaction include: itching of the skin, hives ( raised bumps), swelling of the face, lips, tongue, throat, or trouble swallowing.
• Yellowing of the skin and eyes (jaundice), dark urine, right upper stomach pain, nausea, vomiting, tiredness, loss of appetite, chills, fever, whole body pain. These may be symptoms of liver damage.
• Poor blood sugar control can happen in people who take Casodex (bicalutamide) in combination with LHRH medicines.
• enlargement of breast (gynecomastia) and breast pain

The most common side effects of Casodex (bicalutamide) include:

• hot flashes, or short periods of feeling warm and sweating
• whole body pain in your back, pelvis, stomach
• feeling weak
• constipation
• infection
• nausea
• swelling in your ankles, legs or feet
• diarrhea
• blood in your urine
• waking from sleep to urinate at night
• a decrease in red blood cells (anemia)
• feeling dizzy

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Casodex (bicalutamide) . For more information, ask your healthcare provider or pharmacist.

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

HOW SHOULD I STORE CASODEX (bicalutamide) ?

Store Casodex (bicalutamide) between 20°C-25°C (68°F-77°F).

Keep Casodex (bicalutamide) and all medicines out of the reach of children.

General information about the safe and effective use of Casodex (bicalutamide) .

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Casodex (bicalutamide) for a condition for which it was not prescribed. Do not give Casodex (bicalutamide) to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Casodex (bicalutamide) . If you would like more information about Casodex (bicalutamide) talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Casodex (bicalutamide) that is written for health professionals. For more information go to www.Casodex (bicalutamide) .com or call 1-800-236-9933.

What are the ingredients in Casodex?

Active ingredients include: bicalutamide

Inactive ingredients include: lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, titanium dioxide

Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.