How does this medication work? What will it do for me?

Bicalutamide belongs to a group of medications known as nonsteroidal antiandrogens. Nonsteroidal antiandrogens such as bicalutamide block the effect of the male hormone testosterone in the body.

Bicalutamide is used in combination with another treatment that reduces the amount of testosterone in the body (either with medications called luteinizing hormone releasing hormone (LHRH) analogues or with surgery to remove the testicles) to treat late stage (metastatic) prostate cancer.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each white, film-coated tablet, imprinted with "50" on one side, contains bicalutamide 50 mg. Nonmedicinal ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate, sodium starch glycolate, titanium dioxide, and triethyl citrate.

How should I use this medication?

The recommended dose for bicalutamide is one 50 mg tablet taken once daily at approximately the same time each day.

Bicalutamide may be taken with or without food. This treatment should be started at the same time as treatment with an LHRH analogue (e.g., goserelin), or after surgical removal of the testicles.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with  your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take bicalutamide if you:

  • are allergic to bicalutamide or any ingredients of the medication
  • have early-stage (localized) prostate cancer and would otherwise undergo watchful waiting

This medication is not intended to be used by women or children.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • decrease in appetite
  • dizziness
  • dry skin
  • feeling weak
  • flatulence (passing gas)
  • hair loss or hair re-growth
  • hot flashes
  • impotence or reduction in sexual desire
  • increased sensitivity of the skin to sun; increased risk of sunburn
  • indigestion
  • itching
  • nausea
  • skin rash
  • swelling of breasts with pain or tenderness
  • tiredness
  • weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Contact your doctor as soon as possible if the following side effects occur:

  • abdominal pain
  • blood in the urine
  • chest pain
  • severe itching
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of  liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of heart failure (e.g., tiredness, shortness of breath especially when lying down, swelling of the feet or ankles)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • pain or tenderness in stomach
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • symptoms of lung problems (e.g., shortness of breath, painful breathing, sudden shortness of breath, cough, fever)
  • symptoms of a serious allergic reaction (e.g., hives, shortness of breath, difficulty swallowing, swelling of the face, lips, tongue or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythm: Bicalutamide can cause changes to the normal rhythm of the heart, called QT prolongation. QT prolongation is a serious life-threatening condition. If you are at risk for heart rhythm problems (e.g., have heart failure, angina, low potassium or magnesium levels; have congenital long QT syndrome; or are taking medications that can prolong the QT interval, such as quinidine, procainamide, amiodarone, sotalol, flecainide), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Anemia: Bicalutamide may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Diabetes: Bicalutamide may cause an increase in blood sugar levels. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you.

Heart disease: The risk of heart attack or heart failure is increased for people taking bicalutamide. If you have risk factors for heart disease (obesity, high blood cholesterol, smoking), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Bicalutamide is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

This medication may also cause liver problems. Contact your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Lung disease: Rarely, and particularly when higher doses are used, cases of interstitial lung disease have been reported with this medication. If you experience any symptoms of lung problems such as breathing difficulties, wheezing, cough, fever, or shortness of breath, contact your doctor immediately.

Osteoporosis: Long-term use of bicalutamide has been shown to cause reduced bone strength and may increase the risk of bone fractures. If you have osteoporosis or are at increased risk of developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Children: The safety and effectiveness of this medication have not been determined for children.

What other drugs could interact with this medication?

There may be an interaction between bicalutamide and any of the following:

  • amiodarone
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
  • "azole" antifungals (e.g., ketoconazole, fluconazole)
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • disopyramide
  • dofetilide
  • dronedarone
  • flecainide
  • lomitapide
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • methadone
  • pimozide
  • propafenone
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin)
  • salmeterol
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • sotalol
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.