Bicalutamide tablets

What is this medication?

BICALUTAMIDE (bye ka LOO ta mide) blocks the effect of the male hormone testosterone on the prostate. This medicine is used to treat advanced prostate cancer in men. It is given with other treatments.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Casodex

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• diabetes
• have a partner that is pregnant or could become pregnant
• if you are female (this medicine is not for use in women)
• liver disease
• an unusual or allergic reaction to bicalutamide, other medicines, foods, dyes, or preservatives

How should I use this medication?

Take this medicine by mouth with a glass of water. You may take it with or without food. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• certain medicines for sleep or anxiety
• narcotic medicines for pain
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or health care professional for regular checks on your progress. You may need regular tests to make sure your liver is working properly.

This medicine should not be used in women. Serious side effects to an unborn child are possible. Men should use effective birth control while taking this medicine and for 130 days after stopping it. Talk to your doctor if you have any questions. Contact your doctor right away if your female partner becomes pregnant.

This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• pain or trouble passing urine
• red or dark brown urine
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• back pain
• breast enlargement
• constipation
• hot flashes
• nausea
• swelling of the ankles, feet, hands
• weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.