Bicalutamide

Unless your doctor tells you otherwise, continue your normal diet.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to bicalutamide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Casodex^®

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Bicalutamide is usually taken once per day in the morning or evening. You may take the medicine with or without food. Try to take the medication at the same time each day.

Bicalutamide is given as part of a combination prostate cancer treatment with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. These medicines prevent the testicles from producing testosterone.

Treatment with bicalutamide and LHRH is usually started at the same time. Follow your doctor's instructions.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor's instructions.

You should not stop using bicalutamide suddenly. Stopping suddenly may make your condition worse.

While using bicalutamide, you may need frequent blood tests at your doctor's office.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

Included as part of the PRECAUTIONS section.

CASODEX (bicalutamide) ®
[pronounced cas-o-dex]
(bicalutamide) Tablets

Patients should be informed that therapy with CASODEX (bicalutamide) and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their physician.

During treatment with CASODEX (bicalutamide) , somnolence has been reported, and those patients who experience this symptom should observe caution when driving or operating machines.

Patients should be informed that diabetes, or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving CASODEX (bicalutamide) in combination with LHRH agonists.

Read the Patient Information that comes with Casodex (bicalutamide) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Casodex (bicalutamide) ?

CASODEX (bicalutamide) 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. It is not known if Casodex (bicalutamide) is safe and effective in children.

Who should not take Casodex (bicalutamide) ?

Do not take Casodex (bicalutamide) if:

• you are a woman.
• you are allergic to any of the ingredients in Casodex (bicalutamide) . See the end of this leaflet for a complete list of ingredients

What should I tell my healthcare provider before taking Casodex (bicalutamide) ?

Before you take Casodex (bicalutamide) , tell your healthcare provider about all your medical conditions including if you:

• are a woman (see who should not take Casodex (bicalutamide) )
• are pregnant or think you may be pregnant
• have liver problems
• take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner.
• have diabetes (poor blood sugar control has been reported in people taking Casodex (bicalutamide) in combination with LHRH medicines)

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Casodex (bicalutamide) and other medicines may affect each other causing side effects. Casodex (bicalutamide) may affect the way other medicines work, and other medicines may affect how Casodex (bicalutamide) works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I take Casodex (bicalutamide) ?

• Take Casodex (bicalutamide) exactly as prescribed.
• Take Casodex (bicalutamide) at the same time everyday.
• Your treatment with Casodex (bicalutamide) 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 (bicalutamide) can be taken with or without food.
• If you take too much Casodex (bicalutamide) , call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
• Do not stop taking Casodex (bicalutamide) unless your healthcare provider tells you.
• Your healthcare provider may do blood tests while you take Casodex (bicalutamide)
• Your prostate cancer may get worse while taking Casodex (bicalutamide) in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

What should I avoid while taking Casodex (bicalutamide) ?

Driving and operating machinery. Do not drive, operate machinery, or do other dangerous activities until you know how Casodex (bicalutamide) affects you.

What are the possible side effects of Casodex (bicalutamide) ?

Casodex (bicalutamide) can cause serious side effects. Get medical help right away, if you have:

• trouble breathing with or without a cough or fever. Some people who take Casodex (bicalutamide) get an inflammation in the lungs called interstitial lung disease.
• An allergic reaction. Symptoms of an allergic reaction include: itching of the skin, hives ( raised bumps), swelling of the face, lips, tongue, throat, or trouble swallowing.
• Yellowing of the skin and eyes (jaundice), dark urine, right upper stomach pain, nausea, vomiting, tiredness, loss of appetite, chills, fever, whole body pain. These may be symptoms of liver damage.
• Poor blood sugar control can happen in people who take Casodex (bicalutamide) in combination with LHRH medicines.
• enlargement of breast (gynecomastia) and breast pain

The most common side effects of Casodex (bicalutamide) 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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Casodex (bicalutamide) . For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE CASODEX (bicalutamide) ?

Store Casodex (bicalutamide) between 20°C-25°C (68°F-77°F).

Keep Casodex (bicalutamide) and all medicines out of the reach of children.

General information about the safe and effective use of Casodex (bicalutamide) .

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Casodex (bicalutamide) for a condition for which it was not prescribed. Do not give Casodex (bicalutamide) to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Casodex (bicalutamide) . If you would like more information about Casodex (bicalutamide) talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Casodex (bicalutamide) that is written for health professionals. For more information go to www.Casodex (bicalutamide) .com or call 1-800-236-9933.

What are the ingredients in Casodex?

Active ingredients include: bicalutamide

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

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

There are no studies in pregnant women using bicalutamide. If this medication is used during pregnancy, it may cause harm to your unborn baby. 

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Get emergency medical help if you have signs of an allergic reaction: 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 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.

Usual Adult Dose for Prostate Cancer:

50 mg orally once a day, given at the same time each day.

Antineoplastic agent; a nonsteroidal antiandrogen.1 3 4 14 40 43

Contraindications

• Known hypersensitivity to bicalutamide or any ingredient in the formulation.1

• Should not be used in women, particularly for conditions that are not serious or life-threatening.1

• Women who are or may become pregnant.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Warnings/Precautions

Warnings

May cause fetal harm; contraindicated in pregnant women.1

If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1

Severe liver injury reported, sometimes resulting in hospitalization and/or death;1 26 manifestations generally occurred within first 3–4 months.1

Possible hepatitis or marked increases in serum concentrations of hepatic transaminases.1

Measure serum transaminase concentrations prior to initiation of therapy, at regular intervals during the first 4 months, and periodically thereafter.1

Immediately measure serum transaminase (especially ALT) concentrations if manifestations suggestive of liver dysfunction occur.1

Immediately discontinue if jaundice develops or serum ALT concentration is >2 times ULN; monitor liver function closely thereafter.1

General Precautions

Regularly monitor serum PSA to assess response; if PSA increases, evaluate for possible disease progression.1 17

For patients with objective progression of disease and elevated serum PSA, consider temporarily withdrawing bicalutamide while continuing LHRH analog.1 35 36 37 Withdrawal of bicalutamide may be associated with PSA decrease.31 44

Ensure accuracy of prescription; similarity in spelling of Casodex (the trade name for bicalutamide) and Kapidex (former trade name for dexlansoprazole, a proton-pump inhibitor) may result in errors.217 218 219 223

Specific Populations

Category X.1 (See Fetal/Neonatal Morbidity and Mortality and also Contraindications under Cautions.)

Not known whether bicalutamide is distributed into milk;1 use caution.1

Safety and efficacy not established.1

Use with caution in patients with moderate to severe hepatic impairment.1 3

Consider periodic liver function tests in patients with hepatic impairment receiving long-term therapy.1 35

Not intended for use in women, particularly for nonserious or nonlife-threatening conditions.1

Common Adverse Effects

Combined therapy with LHRH analog: hot flashes, pain (including abdominal, back, and pelvic pain), asthenia, constipation, infection, nausea, dyspnea, diarrhea.1

Gynecomastia and breast pain frequent if bicalutamide used as monotherapy.1

Storage

Oral

20–25°C.1

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 bicalutamide, the following should be considered:

Allergies

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

Pregnancy

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.

Interactions with 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 bicalutamide, 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 bicalutamide 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
• Amiodarone
• Dicumarol
• Domperidone
• Eliglustat
• Phenprocoumon
• Piperaquine

Interactions with Food/Tobacco/Alcohol

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

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

It is very important that your doctor check your progress at regular visits to make sure that bicalutamide 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. Bicalutamide may cause harm in unborn babies.

Liver problems may occur while you are taking bicalutamide. Stop using bicalutamide and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea and vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.

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

Using bicalutamide with an LHRH analog may affect 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.

bicalutamide may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using bicalutamide.

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

bicalutamide may make you sleepy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

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.

• CDX
• ICI-176334

Store at room temperature of 20°C to 25°C (68°F to 77°F).

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

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

To make sure you can safely take bicalutamide, tell your doctor if you have liver disease, diabetes, or any other serious illness.

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

Bicalutamide is not dialyzable.