Posted on April 28th, 2009 by

Class: Hormonal therapy

Generic Name: Bicalutamide (bye-keh-LOO-ta-mide)
Trade Name: Casodex®

For which conditions is this drug approved? Bicalutamide is FDA approved for the treatment of advanced prostate cancer (stage D2), in combination with a luteinizing hormone-releasing hormone (LHRH) analogue.  It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Bicalutamide belongs to a group of drugs referred to as anti-androgens. Prostate cancer is stimulated to grow by the male hormone, testosterone.  Anti-androgens inhibit the effects of testosterone on cancer cells, removing the growth stimulus. Bicalutamide is often given in combination with another hormone agent, classified as a luteinizing hormone – releasing hormone (LHRH) agonist, which helps to block the production of testosterone in the body.

How is bicalutamide typically given (administered)? Bicalutamide is given orally once per day. Patients should take bicalutamide at approximately the same time each day. Patients should speak with their physician about the optimal time to take their medication.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with bicalutamide.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.  Patients’ liver function levels will be monitored prior to treatment and at pre-planned intervals during treatment.

What are the common (occur in 30% or more of patients) side effects of treatment with bicalutamide?

• Hot flashes
• Pain
• Decreased libido, impotence
• Swelling of breasts, breast tenderness

What are the less common (occur in 10% to 29% of patients) side effects of treatment with bicalutamide?

• Back pain
• Weakness
• Constipation
• Pelvic pain
• Infection
• Nausea
• Shortness of breath
• Swelling of the ankles, feet or hands
• Diarrhea
• Blood in the urine
• Increased urinating at night, difficulty urinating
• Low levels of red blood cells – increases the risk of anemia or blood transfusions

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Eat small meals frequently to help alleviate nausea.

Are there any special precautions patients should be aware of before starting treatment?

• Patients may notice a “flare” in their symptoms (pain or side effects caused by the cancer) after beginning bicalutamide. However, these symptoms are temporary and should decrease over time.
• Patients should inform their physician if they are ??pregnant, ??breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Treatment with bicalutamide may interfere with the drug warfarin.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Treatment with bicalutamide may cause dizziness, confusion or drowsiness. Patients should exercise caution when engaging in activities involving mental alertness or when driving (until the response or effects to the drug are known).
• Monitor blood glucose and notify your physician of any changes. This drug may alter your glucose level if you are diabetic.
• If an oral dose is missed, do not double up on doses.  Patients should contact their doctor in this event.
• Keep tablets out of reach of children and return to the pharmacy for safe disposal if treatment is terminated.

When should patients notify their physician?

• Chest pain or palpitations
• Difficulty breathing
• Inability to urinate or low urine volume, change in urine color
• Persistent nausea or vomiting
• Persistent or severe diarrhea or constipation
• Swelling of hands, feet or ankles
• Yellowing of skin or eyes
• Tingling of the hands or feet, or inability to move hands or feet
• Persistent or severe fatigue
• Any pain that is severe or continues

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Copyright © 2016 CancerConnect Last updated 07/10.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.

Tags: B, Hormonal Therapy

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