Bicalutamide

Pronunciation

Generic Name: bicalutamide (BYE-ka-LOO-ta-mide)
Brand Name: Casodex

Bicalutamide is used for:

Treating prostate cancer. Bicalutamide is used in combination with a luteinizing-hormone releasing hormone (LHRH) analog (eg, goserelin, leuprolide). It may also be used for other conditions as determined by your doctor.

Bicalutamide is a nonsteroidal antiandrogen. It works by blocking the action of testosterone.

Do NOT use bicalutamide if:

  • you are allergic to any ingredient in bicalutamide
  • you are a woman
  • you are pregnant, planning to or may become pregnant, or are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using bicalutamide:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems or diabetes

Some MEDICINES MAY INTERACT with bicalutamide. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Oral anticoagulants (eg, warfarin) because the risk of side effects, including bleeding, may be increased
  • Midazolam because the risk of its side effects may be increased by bicalutamide.

This may not be a complete list of all interactions that may occur. Ask your health care provider if bicalutamide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use bicalutamide:

Use bicalutamide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with bicalutamide. Talk to your pharmacist if you have questions about this information.
  • Take bicalutamide by mouth with or without food.
  • Take bicalutamide with your other prostate cancer medicine at the same time each day.
  • If you miss a dose of bicalutamide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use bicalutamide.

Important safety information:

  • Bicalutamide may cause drowsiness or dizzinesss. These effects may be worse if you take it with alcohol or certain medicines. Use bicalutamide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Serious and sometimes fatal liver problems have rarely occurred in patients who take bicalutamide. Symptoms of liver problems may include dark urine, loss of appetite, nausea, pale stools, stomach pain, tiredness, vomiting, weakness, or yellowing of the eyes or skin. Contact your doctor immediately if you experience any of these symptoms.
  • Bicalutamide may cause constipation or diarrhea. If you experience either constipation or diarrhea, ask your doctor or pharmacist to recommend a treatment for you.
  • Diabetes patients - When used with LHRH analogs (eg, goserelin, leuprolide), bicalutamide may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Lab tests, including liver function, prostate-specific antigen (PSA), and blood sugar levels, may be performed while you use bicalutamide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use bicalutamide with caution in the ELDERLY; they may be more sensitive to its effects.
  • Bicalutamide should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Bicalutamide is not approved for use in women. Do not use bicalutamide if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if bicalutamide is found in breast milk. Do not breast-feed while taking bicalutamide.

Possible side effects of bicalutamide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back, pelvic, stomach, or general body pain; constipation; decreased sexual ability; diarrhea; dizziness; frequent urination, especially at night; gas; headache; hot flashes; nausea; stomach upset; sweating; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; difficulty swallowing; unusual hoarseness); black or bloody stools; blurred vision or other vision changes; bone pain; breast growth or pain; changes in the amount of urine produced; chest pain; dark or bloody urine; fainting; fever, chills, or persistent sore throat; flu-like symptoms; increased hunger, thirst, or urination; joint pain, stiffness, or swelling; loss of appetite; mental or mood changes (eg, anxiety, depression); muscle aches or weakness; numbness or tingling of the skin; pale stools; severe or persistent cough; severe or persistent dizziness, drowsiness, or headache; severe or persistent nausea or stomach pain; shortness of breath; swelling of the ankles, legs, or feet; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; weight change; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of bicalutamide:

Store bicalutamide at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep bicalutamide out of the reach of children and away from pets.

General information:

  • If you have any questions about bicalutamide, please talk with your doctor, pharmacist, or other health care provider.
  • Bicalutamide is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take bicalutamide or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about bicalutamide. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to bicalutamide. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using bicalutamide.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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