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CASODEX- bicalutamide tablet


  1. What Is Casodex?
  2. Do Not Take Casodex If You Are:
  3. What Should I Avoid During Treatment With Casodex?
  4. Casodex May Cause Serious Side Effects, Including:
  5. The Most Common Side Effects Of Casodex Include:
  6. How Should I Store Casodex?
  7. What Are The Ingredients In Casodex?
  8. Patient Information
  9. Do Not Take Casodex If:
  10. Before You Take Casodex, Tell Your Healthcare Provider About All Your Medical Conditions Including If You:
  11. What Should I Avoid While Taking Casodex?
  12. What Are The Possible Side Effects Of Casodex?
  13. Get Medical Help Right Away, If You Have:
  14. How Should I Store Casodex?

What Is Casodex? 

CASODEX is a prescription medicine called an androgen receptor inhibitor, used in combination with luteinizing hormone-releasing hormone (LHRH) medicines to treat Stage D2metastatic prostate cancer.

CASODEX 150 mg daily is not approved for use alone or with other treatments.

It is not known if CASODEX is safe and effective in children.

Do Not Take Casodex If You Are: 

allergic to bicalutamide or any of the ingredients in CASODEX.

Take CASODEX exactly as your healthcare provider tells you to take it.
Do not stop taking CASODEX unless your healthcare provider tells you to.
CASODEX can be taken either in the morning or in the evening, but you should take it at the same time every day.
Your treatment with CASODEX should start at the same time as your treatment with the LHRH medicine.
If you miss a CASODEX dose do not take the missed dose, take the next dose at your next scheduled 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 go to the nearest hospital emergency room right away.

What Should I Avoid During Treatment With Casodex? 

Do not drive, operate machinery, or do other dangerous activities until you know how CASODEX affects you. CASODEX can make you sleepy.
Avoid sunlight, sunlamps, and tanning beds, and consider using sunscreen during treatment with CASODEX. Some people have had skin sensitivity to sunlight during treatment with CASODEX.

Casodex May Cause Serious Side Effects, Including: 

Liver problems.Severe liver problems, including liver failure that may need to be treated in a hospital or that may lead to death have happened in people who take CASODEX. Your healthcare provider should do blood tests to check your liver function before and during treatment with CASODEX. Tell your healthcare provider right away if you develop any of these symptoms of liver problems during treatment:
-
yellowing of the skin and eyes (jaundice)
-
dark urine
-
right upper stomach pain
-
nausea
-
vomiting
-
tiredness
-
loss of appetite
-
chills
-
fever
Bleeding problems.Serious bleeding problems have happened in people who take CASODEX in combination with a blood thinner medicine (coumarin anticoagulants). Bleeding problems have happened days to weeks after starting CASODEX treatment. If you take a blood thinner medicine during treatment with CASODEX, tell your healthcare provider if you develop any bleeding or unexplained bruising.
Breast enlargement (gynecomastia) and breast pain.
Blood sugar problems.Poor blood sugar control can happen in people who take CASODEX in combination with LHRH medicines.

Your healthcare provider may do blood tests during treatment with CASODEX to check for side effects.

Your prostate cancer may get worse during treatment with CASODEX in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

Tell your healthcare provider if you have trouble breathing with or without a cough or fever. Some people taking CASODEX get an inflammation in the lungs called interstitial lung disease.

The Most Common Side Effects Of Casodex Include: 

hot flashes (short periods of feeling warm and sweating)
body pain (including back, pelvis, stomach)
feeling weak
constipation
infection
nausea
swelling in your arms, ankles, legs or feet
shortness of breath (dyspnea)
dizziness
diarrhea
blood in your urine
frequent urination at night
a decrease in red blood cells (anemia)

CASODEX may have an effect on male fertility which could be reversible. Talk to your healthcare provider if this is a concern for you.

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. 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? 

Store CASODEX at room temperature between 68 F to 77 F (20 C to 25 C).

Keep CASODEX and all medicines out of the reach of children.

General information about the safe and effective use of CASODEX.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CASODEX for a condition for which it was not prescribed. Do not give CASODEX 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. If you would like more information about CASODEX, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CASODEX that is written for health professionals.

What Are The Ingredients In Casodex? 

Active ingredient: bicalutamide

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

Manufactured by: Corden Pharma GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany
Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623

CASODEX is a trademark of the AstraZeneca group of companies and is licensed to ANI Pharmaceuticals, Inc.

For more information, call 1-800-308-6755.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 8/2019

Patient Information 

Patients should be informed that therapy with CASODEX 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, 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 in combination with LHRH agonists.

Patient Information

CASODEX

[pronounced cas-o dex]

(bicalutamide) Tablets

Read the Patient Information that comes with CASODEX 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.

Do Not Take Casodex If: 

you are a woman.

you are allergic to any of the ingredients in CASODEX.

Before You Take Casodex, Tell Your Healthcare Provider About All Your Medical Conditions Including If You: 

are a woman (

Take CASODEX exactly as prescribed.

Take CASODEX at the same time everyday.

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.

Your prostate cancer may get worse while taking CASODEX 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? 

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

What Are The Possible Side Effects Of Casodex? 

CASODEX 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 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 in combination with LHRH medicines.

Enlargement of breast (gynecomastia) and breast pain.

How Should I Store Casodex? 

Store CASODEX between 20 C-25 C (68 F-77 F).

Keep CASODEX and all medicines out of the reach of children

General information about the safe and effective use of CASODEX.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use CASODEX for a condition for which it was not prescribed. Do not give CASODEX 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. If you would like more information about CASODEX talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CASODEX that is written for health professionals. For more information go to www.CASODEX.com or call 1-800-236-9933.



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