Bicalutamide

What is Bicalutamide?

• Bicalutamide (Casodex) is an androgen receptor inhibitor used to treat prostate cancer that has spread to other parts of the body.

Bicalutamide

Bicalutamide ball-and-stick

Bicalutamide 3D ball

What are the uses of this medicine?

• Bicalutamide (Casodex) is a prescription medicine called an androgen receptor inhibitor, used in combination with lutenizing hormone-releasing hormone (LHRH) medicines to treat stage D2 metatastic prostate cancer.

How does this medicine work?

• Bicalutamide (bye" ka loo' ta mide) is an orally available nonsteroidal antiandrogen that is similar in structure to flutamide and nilutamide.
• Bicalutamide acts by binding to intracellular androgen receptors and competitively inhibiting the action of endogenous androgens on sensitive tissue, including testes, prostate, breast, skin and hypothalamus.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are a woman.
• are allergic to any of the ingredients in Casodex.

What drug interactions can this medicine cause?

• Casodex and other medicines may affect each other causing side effects.
• Casodex may affect the way other medicines work, and other medicines may affect how Casodex works.
• Caution should be used when Casodex is co-administered with CYP3A4 substrates.
• Prothrombin times should be closely monitored in patient already receiving coumarin anticoagulants who are started on Casodex.

Is this medicine FDA approved?

• Bicalutamide was approved for use in the United States in 1995.

How should this medicine be used?

Recommended dosage:

• The recommended dose for Casodex therapy in combination with an LHRH analog is one 50 mg tablet once daily.

Administration:

• Take Casodex at the same time everyday(morning or evening).
• Your treatment with Casodex should start at the same time as your treatment with the LHRH medicine.
• If you miss a dose do not take an extra dose, take the next dose at your regular time. Do not take 2 doses at the same time.
• Casodex can be taken with or without food.
• If you take too much Casodex, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
• Do not stop taking Casodex unless your healthcare provider tells you.
• Your healthcare provider may do blood tests while you take Casodex.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 50 mg tablets

This medicine is available in fallowing brand namesː

• Casodex

What side effects can this medication cause?

The most common side effects of this medicine include:

• hot flashes, or short periods of feeling warm and sweating
• whole body pain in your back, pelvis, stomach
• feeling weak
• constipation
• infection
• nausea
• swelling in your ankles, legs or feet
• diarrhea
• blood in your urine
• waking from sleep to urinate at night
• a decrease in red blood cells (anemia)
• feeling dizzy

Casodex can cause serious side effects include:

• Trouble breathing with or without a cough or fever
• An allergic reaction
• jaundice
• gynecomastia
• Poor blood sugar

What special precautions should I follow?

• Severe hepatic injury and fatal hepatic failure have been observed. Monitor serum transaminase levels prior to starting treatment with Casodex, at regular intervals for the first four months of treatment and periodically thereafter, and for symptoms or signs suggestive of hepatic dysfunction. Use Casodex with caution in patients with hepatic impairment.
• Gynecomastia and breast pain have been reported during treatment with Casodex 150 mg when used as a single agent.
• Casodex is used in combination with a LHRH agonist. LHRH agonists have been shown to cause a reduction in glucose tolerance in males. Consideration should be given to monitoring blood glucose in patients receiving Casodex in combination with LHRH agonists.
• Regular assessments of serum Prostate Specific Antigen (PSA) may be helpful in monitoring the patient’s response. Evaluate for clinical progression if PSA increases.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• A single dose of Casodex that results in symptoms of an overdose considered to be life threatening has not been established.

Management of overdosage:

• There is no specific antidote; treatment of an overdose should be symptomatic.
• In the management of an overdose with Casodex, vomiting may be induced if the patient is alert.
• Dialysis is not likely to be helpful since Casodex is highly protein bound and is extensively metabolized.
• General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, Casodex may cause fetal harm when administered to a pregnant woman.
• Casodex is contraindicated in women, including those who are or may become pregnant.

Can this medicine be used in children?

• The safety and effectiveness of Casodex in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients include: bicalutamide.
• Inactive ingredients include: lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, titanium dioxide.

Who manufactures and distributes this medicine?

• Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE

By: IPR Pharmaceuticals, Inc.

• Canovanas, PR

• Casodex is a registered trademark of the AstraZeneca group of companies.

What should I know about storage and disposal of this medication?

• Store Casodex between 20°C-25°C (68°F-77°F).
• Keep Casodex and all medicines out of the reach of children.

• Dailymed label info on Bicalutamide
• FDA Bicalutamide