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

Used with other medicines to treat prostate cancer.

Brand Name(s):

Casodex

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine at the same time each day.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Skip the missed dose and take the next dose at your regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Some medicines may affect how bicalutamide works. Tell your doctor if you are using midazolam or a blood thinner medicine (including warfarin).

Warnings While Using This Medicine:

• This medicine may cause birth defects if the father is using it when his sexual partner becomes pregnant. Male patients with female partners should use an effective form of birth control during treatment with this medicine and for 130 days after the last dose.
• Tell your doctor if you have liver disease, blood clotting problems, or diabetes.
• This medicine may cause the following problems:
  • Liver problems
  • Increased risk of bleeding when used together with a blood thinner medicine
  • Breast swelling and pain
  • Changes in blood sugar levels
• This medicine may make you drowsy or sleepy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Do not stop using this medicine without talking to your doctor first.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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, red or pink urine, difficult or painful urination
• Chest pain or trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Increased hunger or thirst, tiredness, blurred vision
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, tiredness, or weakness

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

• Back, pelvic, or bone pain
• Breast pain, swelling, or tenderness
• Constipation, diarrhea, nausea
• Dizziness
• Sweating, warmth or redness in your face, neck, arms, or upper chest
• Trouble getting an erection

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