Casodex

Bicalutamide is an anti-androgen. It works in the body by preventing the actions of androgens (male hormones).

Bicalutamide is used together with another hormone to treat prostate cancer.

Bicalutamide may also be used for purposes not listed in this medication guide.

Although bicalutamide is not for use by women, this medicine can cause birth defects if a woman is exposed to it during pregnancy.

You should not use this medicine if you are allergic to bicalutamide.

Bicalutamide should never be taken by a woman or a child.

Although bicalutamide is not for use by women, this medicine can cause birth defects if a woman is exposed to it during pregnancy.

To make sure bicalutamide is safe for you, tell your doctor if you have:

• liver disease;
• diabetes; or
• if you also take a blood thinner (warfarin, Coumadin, Jantoven).

Contraindications

Hypersensitivity

Female patients (esp pregnant-may harm fetus)

Cautions

Hepatic impairment

Severe liver injury resulting in hospitalization or death reported

Spermatogenesi inhibition reported

Gynecomastia and breast pain reported during therapy when used as single agent

May reduce glucose tolerance in males when used in combination with LHRH; monitor blood glucose

Monitor prostate specific antigen (PSA) progression if PSA increases

Antiandrogen therapy may cause morphological changes in spermatozoa; based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after administering final dose administered

Based on animal studies, therapy can lead to inhibition of spermatogenesis and may impair fertility in males of reproductive potential; long-term effects on male fertility not studied

Mechanism of Action

Nonsteroidal antiandrogen, competitively binds androgen receptors and inhibits testosterone stimulation of cell growth in prostate cancer

Pharmacokinetics

Half-Life: 5.8 d

Peak plasma time: 31 hr

Peak plasma concentration: 0.77 mcg/mL

Protein Bound: 96%

Metabolism: Liver

Clearance: 0.32 L/hr

Excretion: Urine (36%), feces (42%)

Dialyzable: No

Casodex is not approved for use in women. Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Casodex falls into category X and must not be used by women who are pregnant. There are no studies in pregnant women using Casodex. If this medication is used during pregnancy, it may cause harm to your unborn baby. 

Casodex is not approved for use in women. It is unknown if Casodex is excreted in human breast milk or if it will harm your nursing baby. 

If you take too much Casodex, call your local Poison Control Center or seek emergency medical attention.

• Alecensa
• Alkeran
• Axumin
• Eligard
• Firmagon
• Jevtana
• Lupron
• Lupron Depot 11.25
• Lupron Depot 3.75
• Lupron Depot 7.5
• Plenaxis

• Provenge
• Trelstar
• Trelstar Depot
• Trelstar LA
• Vantas
• Viadur
• Xofigo
• Xtandi
• Zoladex 3.6
• Zometa
• Zytiga

Read the Casodex User Reviews »

© Casodex Patient Information is supplied by Cerner Multum, Inc. and Casodex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Although bicalutamide is not for use by women, this medicine can cause birth defects if a woman is exposed to it during pregnancy.

• A selective antiandrogen with no androgenic or progestational activity in various animal models.12 17 43

• Competitively blocks nuclear androgen receptors in target tissues (e.g., adrenal cortex, prostate, seminal vesicles).1 11 12 14 16 34 43

• Blockade of androgen receptors in the hormone-sensitive tumor cells may result in growth arrest or transient tumor regression through inhibition of androgen-dependent DNA and protein synthesis.1 11 12 14 16 34 43

• Inhibits initial androgenic stimulation and potential exacerbation of symptoms (e.g., bone pain, urinary obstruction, liver pain, impending spinal cord compression) associated with the first month of LHRH analog therapy.8 10 14 16 18 21 23 25 40

Use Casodex as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Take this medicine at the same time of day.
• To gain the most benefit, do not miss doses.
• Keep taking Casodex as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

. Hepatitis

Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported post-marketing in association with the use of Casodex. Hepatotoxicity in these reports generally occurred within the first three to four months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of Casodex patients in controlled clinical trials.

Serum transaminase levels should be measured prior to starting treatment with Casodex, at regular intervals for the first four months of treatment, and periodically thereafter. If clinical symptoms or signs suggestive of liver dysfunction occur (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, “flu-like” symptoms, dark urine, jaundice, or right upper quadrant tenderness), the serum transaminases, in particular the serum ALT, should be measured immediately. If at any time a patient has jaundice, or their ALT rises above two times the upper limit of normal, Casodex should be immediately discontinued with close follow-up of liver function.

. Gynecomastia and Breast Pain

In clinical trials with Casodex 150 mg as a single agent for prostate cancer, gynecomastia and breast pain have been reported in up to 38% and 39% of patients, respectively.

. Glucose Tolerance

A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycemic control in those with pre-existing diabetes. Consideration should therefore be given to monitoring blood glucose in patients receiving Casodex in combination with LHRH agonists.

. Laboratory Tests

Regular assessments of serum Prostate Specific Antigen (PSA) may be helpful in monitoring the patient’s response. If PSA levels rise during Casodex therapy, the patient should be evaluated for clinical progression. For patients who have objective progression of disease together with an elevated PSA, a treatment-free period of antiandrogen, while continuing the LHRH analog, may be considered.

Spermatozoa Morphology and Contraception

Antiandrogen therapy may cause morphological changes in spermatozoa. Although the effect of bicalutamide on sperm morphology has not been evaluated and no such changes have been reported for patients who received Casodex, patients and/or their partners should follow adequate contraception during and for 130 days after Casodex therapy.

Get emergency medical help if you have any signs of an allergic reaction to Casodex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• breast pain or swelling;

• blood in your urine;

• fever, chills;

• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

• low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• liver problems - nausea, upper stomach pain, feeling tired, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common Casodex side effects may include:

• hot flashes;

• pain in your back, pelvis, or stomach;

• swelling in your hands, ankles, or feet;

• increased night-time urination;

• weakness, dizziness; or

• nausea, diarrhea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.