Pronunciation:

bye-ka-LOO-ta-mide

Brand Names:

• Casodex

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiandrogen

Uses of This Medicine:

Bicalutamide is used together with a luteinizing hormone releasing hormone (LHRH) analog (eg, goserelin or leuprolide) to treat stage D₂ 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.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bicalutamide in the elderly.

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.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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
• Domperidone
• Levoketoconazole
• Methotrexate
• Phenprocoumon
• Piperaquine
• Warfarin

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clotting problems or
• Diabetes or
• Liver disease (including hepatitis)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine 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.

This medicine should come with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have questions.

It is best to take this medicine at the same time each day, in the morning or in the evening.

This medicine should be started at the same time as treatment with a luteinizing hormone-releasing hormone (LHRH) analog (eg, goserelin, leuprolide, Lupron®, or Zoladex®). Do not stop taking these medicines without checking with your doctor first.

You may take this medicine with food or on an empty stomach.

Dosing—

The dose of this medicine 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 this medicine. 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, in the morning or in the evening.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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 This Medicine:

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

Women who are pregnant or may become pregnant should not use bicalutamide tablets. Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Male patients who have female partners should use effective birth control during treatment with this medicine and for 130 days after the last dose. If you think your female partner has become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Bicalutamide may cause serious bleeding when you use it together with a blood thinner medicine (eg, warfarin). Talk to your doctor if you have concerns.

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

Using this medicine with an LHRH analog may affect your blood sugar levels. If you notice a change in the results of your blood sugar tests or if you have any questions, check with your doctor.

This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure any doctor or dentist who treats you knows that you are using this medicine.

If you plan to have children, talk with your doctor before using this medicine. This medicine may cause some men to become infertile (unable to have children), at least temporarily.

This medicine may make you sleepy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine

blurred vision

body aches or pain

chills

congestion

cough

cough producing mucus

difficult or labored breathing

dizziness

dryness or soreness of the throat

fever

headache

hoarseness

lower back or side pain

nervousness

painful or difficult urination

pounding in the ears

rapid weight gain

runny nose

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

Less common

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 feeling while urinating

burning, tingling, numbness, or pain in the hands, arms, feet, or legs

change in bowel habits

chest pain, discomfort, tightness or heaviness

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

irregular breathing or heartbeat

joint stiffness or swelling

lightheadedness

loss of appetite

lump or swelling in the abdomen or stomach

nausea

no blood pressure or pulse

noisy breathing

pain or discomfort in the arms, jaw, back, or neck

painful blisters on the 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 the heart

sunken eyes

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

Incidence not known

Bleeding gums

coughing up blood

hives or welts, itching, skin rash

increased menstrual flow or vaginal bleeding

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

paralysis

prolonged bleeding from cuts

red or black, tarry stools

red or dark brown urine

redness of the skin

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:

More common

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

leg cramps

loss in sexual ability, desire, drive, or performance

loss of strength or energy

muscle ache, cramp, pain, or weakness

pain in the pelvis

pain or tenderness around the eyes and cheekbones

passing of gas

sleepiness or unusual drowsiness

stomach pain or fullness

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.