Bicalutamide is used with another medication (gonadotropin-releasing hormone (GnRH) agonists; such as leuprolide or goserelin) to treat metastatic prostate cancer (cancer that started in the prostate and has spread to other parts of the body). Bicalutamide is in a class of medications called nonsteroidal antiandrogens. It works by blocking the effect of androgen (a male hormone), to stop the growth and spread of cancer cells.

Bicalutamide comes as a tablet to take by mouth. It is usually taken with or without food once a day, either in the morning or evening. Take bicalutamide at around the same time every day. You should begin taking bicalutamide on the same day you begin injecting the luteinizing hormone-releasing hormone. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take bicalutamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Bicalutamide along with the luteinizing hormone-releasing hormone may help stop the growth and spread of cancer cells but does not cure prostate cancer. Continue to take both bicalutamide and the luteinizing hormone-releasing hormone even if you feel better. Do not stop taking these medications without talking to your doctor.

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

Before taking bicalutamide,

• tell your doctor and pharmacist if you are allergic to bicalutamide, any other medications, or any of the ingredients in bicalutamide tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); anticoagulants (‘blood thinners’) such as warfarin (Coumadin); aripiprazole (Abilify); buspirone (Buspar); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), felodipine (Plendil), nifedipine (Adalat, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); chlorpheniramine; cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), lovastatin (Mevacor), and simvastatin (Zocor); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); diazepam (Valium); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir), and saquinavir (Invirase, Fortovase); methadone (Dolophine); midazolam (Versed); pimozide (Orap); quinidine (Quinidex, Quinaglute); quinine; sildenafil (Viagra); tacrolimus (Prograf); tamoxifen (Nolvadex); telithromycin (Ketek); trazodone (Desyrel); triazolam (Halcion); and vincristine (Vincasar). Many other medications may also interact with bicalutamide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had liver disease.
• you should know that bicalutamide is only for use in men. If taken by pregnant women, bicalutamide can cause abnormalities in the fetus. Women who are or may become pregnant should not take bicalutamide. If you take bicalutamide while you are pregnant, call your doctor immediately.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• hot flashes or flushing
• bone, back, or pelvic pain
• muscle weakness
• muscle or joint pain
• headache
• shortness of breath
• increased blood pressure
• swelling of the hands, feet, ankles, or lower legs
• cough
• constipation
• nausea
• vomiting
• abdominal pain
• diarrhea
• gas
• change in weight (loss or gain)
• loss of appetite
• dizziness
• pain, burning, or tingling in the hands or feet
• difficulty sleeping
• feeling of uneasiness or dread
• rash
• sweating
• inability to get or keep an erection
• need to urinate frequently during the night
• bloody urine
• painful or difficult urination
• frequent and urgent need to urinate
• difficulty emptying bladder
• painful or swollen breasts

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

• yellowing of the skin or eyes
• pain in the upper right part of the stomach
• extreme tiredness
• unusual bleeding or bruising
• lack of energy
• upset stomach
• loss of appetite
• flu-like symptoms
• dull or sharp side pain
• chest pain

Bicalutamide may cause other side effects. Call your doctor if you have any unusual problems while taking 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).

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.

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.

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.

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