CASODEX® (bicalutamide)
- December 13, 2020
- 0
CASODEX®
(cas-o–dex)
(bicalutamide) tablet
Chemotherapy
AFINITOR®
a-fin-it-or
Everolimus tablets
Chemotherapy
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 D2 metastatic 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. See the end of this Patient Information leaflet for a complete list of ingredients in CASODEX. Get medical help right away if you develop any of the following symptoms of an allergic reaction:
- itching
- swelling of the face, lips or tongue
- hives (raised bumps)
- trouble breathing or swallowing
- female. CASODEX is not for use by women.
- pregnant or may become pregnant. CASODEX may harm your unborn baby.
Before taking CASODEX, tell your healthcare provider about all your medical conditions, including if you:
- 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.
- have a female partner who can become pregnant. Males who have a female partner who can become pregnant should use effective birth control during treatment with CASODEX and for 130 days after the final dose. Talk to your healthcare provider if you have any questions about birth control.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
CASODEX may affect the way other medicines work and other medicines may affect how CASODEX works, causing side effects. 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?
- 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.
What are the possible side effects of 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)
- right upper stomach pain
- vomiting
- loss of appetite
- fever
- dark urine
- nausea
- tiredness
- chills
- 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
- fever
- infection
- nausea
- swelling in your arms, ankles, legs or feet
- shortness of breath (dyspnea)
- dizziness
- blood in your urine
- diarrhea
- frequent urination at night
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
Tell your healthcare provider if you have vomiting, diarrhea, or signs of dehydration that does not go away. CASODEX may cause fertility problems in males and females, which may affect your ability to have a child.
Talk to your healthcare provider if this is a concern for you. These are not all of the possible side effects of CASODEX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
