Casodex

(Bicalutamide)

The active ingredient in Casodex is bicalutamide. Male sex hormones called androgens, like testosterone, can be harnessed by prostate cancer cells to grow. Bicalutamide is an antiandrogen medication. It blocks androgen receptors in the prostate gland or prostate cancer cells to prevent them from using hormones to grow.

It is only indicated in combination with a luteinizing hormone-releasing hormone (LHRH) analogue like leuprolide or goserelin, or in the context of surgical castration.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Casodex. However, the following is a synopsis of the general guidelines for the use of Casodex:

-The usual dosing of Casodex is 50mg once daily.

-Swallow the tablet whole with a glass of water.

-In the event of a missed dose of Casodex, do not take an extra dose. Take the next dose as scheduled.

You may be required to do regular blood tests to monitor your prostate specific antigen (PSA), liver function, blood counts, etc. You may also be required to receive an ECG before starting the medication.

If there is a chance that your partner may get pregnant, you and/or your partner should use a method of contraception (birth control) while you are using Casodex and for 130 days after stopping the medication.

The most common side effects of bicalutamide seen in clinical trials as compared to placebo include:

-Nausea

-Constipation

-Dizziness

-Hot flashes

-Feeling weak or fatigued

-Anemia (low red blood cell count)

-Mood changes

-Weight gain

-Breast pain

-Reduced sex drive

-Swelling of the legs and ankles

-Rarely, Casodex may make your skin more sensitive to the sun.

Some individuals may experience serious side effects while using Casodex. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

-Jaundice (yellowing of the skin and eyes): This can indicate liver damage.

-Palpitations or chest pain.

-Shortness of breath with or without a cough and fever: This may be inflammation of the lungs (interstitial lung disease).

-Signs of an allergic reaction.

These are not all of the possible side effects of Casodex. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Casodex may impair fertility during treatment. The long-term effects of Casodex on fertility are not well studied.

Before starting Casodex, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

-Liver problems or lung problems.

-Low bone mineral density (weak bones).

-Low red blood cell count (anemia).

-A history of blood clots.

-A heart condition, including long QT syndrome or other heart rhythm problems.

-Diabetes: Bicalutamide may cause increased blood sugar levels.

-Gynecomastia (growth of breast tissue).

Boxed Warning

The use of Cosadex 150mg daily is no longer indicated.

Cosadex may cause liver failure, which can be fatal.

Cosadex may cause interstitial lung disease, which can be life-threatening.

Cosadex should not be used in:

-People who have had an allergic reaction to bicalutamide or other ingredients of the formulation.

-People who have localized early-stage prostate cancer

-Women.

-Children. The safety and efficacy of Casodex in pediatric oncology have not been studied.

The antiandrogen effects of Casodex are rapid, but it may take weeks to see improvement in your PSA values. Your doctor will need you to get blood work done regularly to monitor whether Casodex is working for you.

When Casodex is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

-Blood thinners such as warfarin.

-Medications that can increase the risk of abnormal heart rhythms, or medications that treat heart rhythm problems like amiodarone, quinidine, propafenone, and others.

Casodex is available in 50mg tablets.

Casodex tablets should be stored at room temperature, in the original container, away from children.

Casodex is manufactured by AstraZeneca Canada Inc.

There is no generic version of brand-name Casodex at this time.

Casodex is intended for long-term use. Your doctor may choose to stop Casodex if your cancer progresses while on the medication. Always speak with your doctor before making a decision about your cancer treatment.

Casodex is not indicated in women and should not be taken in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Casodex is not indicated in women and should not be taken while breastfeeding. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.