Bicalutamide (By mouth)

Introduction

Bicalutamide (bye-ka-LOO-ta-mide)

Used together with other medicines (such as a luteinizing hormone-releasing hormone or LHRH analog) to treat prostate cancer. Belongs to the group of medicines called antiandrogens.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should be started at the same time as treatment with an LHRH analog (such as goserelin, leuprolide, Lupron®, or Zoladex®). Do not stop taking these medicines without checking with your doctor first.
• You may take this medicine with or without food.
• It is best to take this medicine at the same time every day. If you have been directed to take the medicine once a day, you may take it either in the morning or in the evening.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to take your medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using midazolam (Versed®) or a blood thinner (such as warfarin Coumadin®).

Warnings While Using This Medicine

• Women who are pregnant or may become pregnant should not use this medicine. Bicalutamide may cause harm in unborn babies.
• Make sure your doctor knows if you have liver disease or diabetes.
• Liver problems may occur while you are taking this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea and vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.
• This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.
• Using this medicine with a luteinizing hormone-releasing hormone (LHRH) analog may affect blood sugar levels. If you notice a change in the results of your blood sugar tests or if you have any questions, check with your doctor.
• This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• If you plan to have children, talk with your doctor before using this medicine. This medicine may cause some men to become infertile (unable to have children), at least temporarily.
• This medicine may make you drowsy or sleepy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, difficult or painful urination.
• Chest pain.
• Dark-colored urine or pale stools.
• Fast, slow, pounding, or uneven heartbeat.
• Fever, chills, cough, sore throat, sweating, and body aches.
• Increased hunger or thirst.
• Nausea, vomiting, loss of appetite, or pain in the upper stomach.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Shortness of breath or troubled breathing.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Back or bone pain.
• Breast pain, swelling, or tenderness.
• Constipation, diarrhea, gas, or upset stomach.
• Dizziness or headache.
• Mild pain.
• Skin rash.
• Trouble having sex or loss of interest in sex.
• Trouble sleeping.
• Unusual tiredness or weakness.
• Warmth or redness in your face, neck, arms, or upper chest.
• Weight loss.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

Brand Name(s)

Casodex

When This Medicine Should Not Be Used