bicalutamide (Oral route)

bye-ka-LOO-ta-mide

Commonly used brand name(s):

In the U.S.

• Casodex

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiandrogen

Uses For bicalutamide

Bicalutamide is used together with another medicine to treat metastatic prostate cancer (cancer that has spread) in men. Bicalutamide belongs to the group of medicines called antiandrogens. It works by blocking the effects of testosterone (a male hormone), which helps stop the growth and spread of cancer cells. Bicalutamide will always be given together with a luteinizing hormone-releasing hormone (LHRH) analogue (e.g., goserelin or leuprolide).

bicalutamide is available only with your doctor's prescription.

Before Using bicalutamide

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bicalutamide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bicalutamide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of bicalutamide in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of bicalutamide in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using bicalutamide with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Dicumarol
• Phenprocoumon

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of bicalutamide. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease—Use with caution. May make this condition worse.

Proper Use of bicalutamide

Take bicalutamide only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

It is best to take bicalutamide at the same time each day. If you have been directed to take the medicine once a day, you may take it either in the morning or in the evening.

bicalutamide should be started at the same time as treatment with a luteinizing hormone-releasing hormone (LHRH) analogue. Do not stop taking these medicines without checking with your doctor first.

You may take bicalutamide with food or on an empty stomach.

Dosing

The dose of bicalutamide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of bicalutamide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For prostate cancer:
    • Adults—50 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of bicalutamide, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using bicalutamide

It is very important that your doctor check your progress at regular visits to make sure that bicalutamide is working properly. Blood tests may be needed to check for unwanted effects.

Liver problems may occur while you are using bicalutamide. Stop using bicalutamide and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea and vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.

bicalutamide may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

bicalutamide Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• blurred vision
• body aches or pain
• congestion
• cough or hoarseness
• cough producing mucus
• difficult or labored breathing
• dizziness
• dryness or soreness of the throat
• fever or chills
• headache
• lower back or side pain
• nervousness
• painful or difficult urination
• pounding in the ears
• rapid weight gain
• runny nose
• shortness of breath
• slow or fast heartbeat
• sweating
• tender, swollen glands in the neck
• tightness in the chest
• tingling of the hands or feet
• trouble with swallowing
• unusual weight gain or loss
• voice changes
• wheezing

• Abnormal growth filled with fluid or semisolid material
• ankle, knee, or great toe joint pain
• arm, back, or jaw pain
• bleeding from the rectum or bloody stools
• blindness
• bloody nose
• burning while urinating
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• change in bowel habits
• chest pain or discomfort
• chest tightness or heaviness
• chills
• confusion
• decrease in frequency of urination
• decrease in urine volume
• decreased vision
• difficulty in passing urine (dribbling)
• difficulty with swallowing or eating
• dilated neck veins
• dry mouth
• fainting
• fast or irregular heartbeat
• fever
• irregular breathing
• joint stiffness or swelling
• lightheadedness
• loss of appetite
• lump or swelling in the abdomen
• nausea
• no blood pressure or pulse
• noisy breathing
• pain in the neck
• pain or discomfort in the arms, jaw, back, or neck
• painful blisters on trunk of the body
• persistent non-healing sore
• rapid, shallow breathing
• reddish patch or irritated area
• sensation of pins and needles
• shiny bump
• stabbing pain
• stomach discomfort
• stopping of heart
• sunken eyes
• swelling of the face, fingers, feet, or lower legs
• thirst
• tumor
• unconsciousness
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• weight gain
• white, yellow or waxy scar-like area
• wrinkled skin
• yellow skin or eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• belching
• breast pain
• constipation
• decreased interest in sexual intercourse
• diarrhea
• difficulty with moving
• dry skin
• hair loss or thinning of the hair
• heartburn
• inability to have or keep an erection
• indigestion
• itching
• lack or loss of strength
• leg cramps
• loss in sexual ability, desire, drive, or performance
• loss of strength or energy
• muscle aching or cramping
• muscle pain or weakness
• nervousness
• pain in the pelvis
• pain or tenderness around the eyes and cheekbones
• passing of gas
• rash
• sleepiness or unusual drowsiness
• stomach pain, fullness, or discomfort
• stuffy or runny nose
• swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.