Bicalutamide is a prescription medicine belonging to a class of medicines called non-steroidal androgen receptor inhibitors.

Bicalutamide is used to treat prostate cancer that has spread to other parts of the body (metastatic).

Bicalutamide is given in combination with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. LHRH helps prevent the testicles from producing testosterone.

It is not known if bicalutamide tablets are safe and effective in children.

Bicalutamide can harm an unborn baby if you father a child while using this medicine. Use effective birth control to prevent pregnancy while using bicalutamide and for at least 130 days (about 19 weeks) after your last dose.

Take bicalutamide exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Bicalutamide is usually taken once per day in the morning or evening.

Take the medicine at the same time each day, with or without food.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor's instructions.

You should not stop using bicalutamide unless your doctor tells you to.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Prostate Cancer:

In combination with an LHRH analog: 50 mg orally once a day (morning or evening)

Comments:
-Therapy with this drug should be started at the same time as therapy with an LHRH analog.
-If a dose is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Use: For use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate

You should not use this medicine if you are allergic to bicalutamide.

Use effective birth control if your sex partner is able to get pregnant. Bicalutamide can harm an unborn baby if you father a child while using this medicine. Keep using birth control for at least 130 days (about 19 weeks) after your last dose.

Bicalutamide is not for use by women or children.

This medicine can cause birth defects if a woman takes it during pregnancy.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease; or

• diabetes.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Bicalutamide could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to bicalutamide: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• breast pain or swelling;

• sudden chest pain, wheezing, dry cough, feeling short of breath;

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

• liver problems - nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), fever, chills;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• (if you also take warfarin) unusual bruising or bleeding.

Common bicalutamide side effects may include:

• anemia;

• blood in your urine;

• fever, chills, flu-like symptoms;

• trouble breathing;

• hot flashes;

• pain in your back, pelvis, or stomach;

• swelling in your arms, ankles, legs, or feet;

• increased night-time urination;

• weakness, dizziness; or

• nausea, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• a blood thinner (warfarin, Coumadin, Jantoven).

This list is not complete. Other drugs may interact with bicalutamide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.