Description and Brand Names

US Brand Name

  1. Casodex

Descriptions


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.

This product is available in the following dosage forms:

  • Tablet

Before Using

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.

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

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

Breastfeeding

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.

Drug Interactions

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
  • 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

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

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

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

  1. Bloating or swelling of the face, arms, hands, lower legs, or feet
  2. blood in the urine
  3. blurred vision
  4. body aches or pain
  5. chills
  6. congestion
  7. cough
  8. cough producing mucus
  9. difficult or labored breathing
  10. dizziness
  11. dryness or soreness of the throat
  12. fever
  13. headache
  14. hoarseness
  15. lower back or side pain
  16. nervousness
  17. painful or difficult urination
  18. pounding in the ears
  19. rapid weight gain
  20. runny nose
  21. slow or fast heartbeat
  22. sweating
  23. tender, swollen glands in the neck
  24. tightness in the chest
  25. tingling of the hands or feet
  26. trouble with swallowing
  27. unusual weight gain or loss
  28. voice changes

Less common

  1. Abnormal growth filled with fluid or semisolid material
  2. ankle, knee, or great toe joint pain
  3. arm, back, or jaw pain
  4. bleeding from the rectum or bloody stools
  5. blindness
  6. bloody nose
  7. burning feeling while urinating
  8. burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  9. change in bowel habits
  10. chest pain, discomfort, tightness or heaviness
  11. confusion
  12. decrease in frequency of urination
  13. decrease in urine volume
  14. decreased vision
  15. difficulty in passing urine (dribbling)
  16. difficulty with swallowing or eating
  17. dilated neck veins
  18. dry mouth
  19. fainting
  20. irregular breathing or heartbeat
  21. joint stiffness or swelling
  22. lightheadedness
  23. loss of appetite
  24. lump or swelling in the abdomen or stomach
  25. nausea
  26. no blood pressure or pulse
  27. noisy breathing
  28. pain or discomfort in the arms, jaw, back, or neck
  29. painful blisters on the trunk of the body
  30. persistent, non-healing sore
  31. rapid, shallow breathing
  32. reddish patch or irritated area
  33. sensation of pins and needles
  34. shiny bump
  35. stabbing pain
  36. stomach discomfort
  37. stopping of the heart
  38. sunken eyes
  39. thirst
  40. tumor
  41. unconsciousness
  42. unexplained weight loss
  43. unusual tiredness or weakness
  44. vomiting
  45. weight gain
  46. white, yellow, or waxy scar-like area
  47. wrinkled skin
  48. yellow skin or eyes

Incidence not known

  1. Bleeding gums
  2. coughing up blood
  3. hives or welts, itching, skin rash
  4. increased menstrual flow or vaginal bleeding
  5. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  6. paralysis
  7. prolonged bleeding from cuts
  8. red or black, tarry stools
  9. red or dark brown urine
  10. 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

  1. Belching
  2. breast pain
  3. constipation
  4. decreased interest in sexual intercourse
  5. diarrhea
  6. difficulty with moving
  7. dry skin
  8. hair loss or thinning of the hair
  9. heartburn
  10. inability to have or keep an erection
  11. indigestion
  12. leg cramps
  13. loss in sexual ability, desire, drive, or performance
  14. loss of strength or energy
  15. muscle ache, cramp, pain, or weakness
  16. pain in the pelvis
  17. pain or tenderness around the eyes and cheekbones
  18. passing of gas
  19. sleepiness or unusual drowsiness
  20. stomach pain or fullness
  21. stuffy or runny nose
  22. 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.