Details for: CASODEX
Company: ASTRAZENECA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02184478 | CASODEX | BICALUTAMIDE | 50 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
CASODEX is used in the treatment of advanced prostate cancer in combination with other drugs (LHRH analogues) which reduce the levels of androgens in the body or surgery.
What it does
Androgens are male sex hormones within the body which can cause tumour growth within the prostate. CASODEX belongs to a group of medicines called non-steroidal antiandrogens. This means that CASODEX interferes with some of the actions of androgens to prevent the tumour from growing.
What are the Stages of Prostate Cancer:
- Localized disease – the early stages of disease when prostate cancer is confined to the prostate gland.
- Locally advanced disease – the disease progresses and the cancer spreads to other tissues within the pelvis.
- Advanced or metastatic disease – the disease progresses to other parts of the body.
The PSA (Prostate Specific Antigen) test is a simple blood test for a protein produced by the prostate (PSA). This test has helped in the detection of prostate cancer resulting in an increase in the number of men whose prostate cancer is detected at an early stage.
What are the Treatment Options for Localized Prostate
Cancer:
The optimal treatment for a given individual will depend on
the specific circumstances of his case. For localized disease,
patients are usually offered one of the following:
- Surgery to remove the prostate
- Targeted radiotherapy to kill the cancer cells in the prostate
- No treatment initially (watchful waiting) whereby the patient is monitored until there are signs of progression before treatment is started.
When it should not be used
- Do not take CASODEX if you have early phase (localized) prostate cancer requiring watchful waiting.
- Do not take CASODEX if you are allergic to bicalutamide or any of the nonmedicinal ingredients in CASODEX.
- CASODEX must not be taken by women, including pregnant women or mothers who are breast feeding their babies.
- CASODEX must not be given to children.
What the medicinal ingredient is
The active ingredient in CASODEX is bicalutamide.
What the non-medicinal ingredients are
Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, methylhydroxypropylcellulose, polyethylene glycol 300, polyvidone, sodium starch glycollate and titanium dioxide.
What dosage form it comes in
CASODEX comes in tablets containing 50 milligrams (mg) of bicalutamide as the active ingredient
CASODEX comes in blister strips of 15 tablets, 30 tablets per package
Warnings and precautions
- CASODEX should only be prescribed by a doctor experienced with the treatment of prostate cancer.
- CASODEX 150mg/day dose should not be used.
- CASODEX may rarely be associated with liver failure; some cases have been fatal.
- CASODEX may be associated with uncommon cases of interstitial lung disease; some cases have been fatal
BEFORE you use CASODEX talk to your doctor or pharmacist if:
- You have liver disease.
- You have lung disease.
- You have low bone mineral density (BMD).
- You have low red blood cell count (anemia).
- You have heart or blood vessel conditions, including heart disease, a heart condition called ‘long QT syndrome’ or family history of this heart condition., heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased in such patients when using CASODEX.
If you go into hospital let the medical staff know you are taking
CASODEX.
If you are taking CASODEX, you and/or your partner should
use birth control while you are taking CASODEX and for at least 130 days after stopping CASODEX. Talk to your doctor if you have any questions about birth control.
Avoid direct exposure to excessive sunlight or UV-light while you are taking CASODEX.
CASODEX may make you feel sleepy. Do not drive or use machines until you know how the drug affects you.
Interactions with this medication
Please inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.
- In particular please inform your doctor if you are taking oral anti-coagulants (to prevent blood clots)
- If you are taking any medicines that may increase the risk of having an abnormal heart rhythm.
- If you are taking medicines used to treat heart rhythm problems.
Proper use of this medication
Follow your doctor's instructions about when and how to take your tablets. Ask your doctor or pharmacist if you are not sure.
- The usual adult dose is 50 mg daily.
- Swallow the tablet(s) whole with a drink of water.
- Try to take your dose at the same time each day.
During the first few months of use, you may be monitored by your physician for signs of changes in your liver function. In approximately 2.0% of patients, such changes may lead to withdrawal of therapy.
If you experience a rise in PSA while taking CASODEX, your physician may discontinue CASODEX for several weeks in order to monitor your condition off treatment.
Overdose
Missed Dose
You should take CASODEX as prescribed. However, if you miss a dose do not take an extra dose, just resume your usual schedule.
Side effects and what to do about them
Like all medicines, CASODEX 50 mg can have side effects.
Side effects that are very common (more than 10 in every 100 patients are likely to have them):
- dizziness
- nausea
- hot flushes
- feeling weak
- decreased red blood cell count (anemia)
- puffiness/swelling
- constipation
Side effects that are common (1 to 10 in every 100 patients are likely to have them)
- loss of appetite
- reduced sex drive
- depression
- sleepiness
- indigestion
- flatulence
- loss of hair or hair re-growth
- rash
- itching
- dry skin
- impotence
- chest pain
- tender or enlarged breast tissue
- weight gain
- heart failure
- heart attack
Occasionally CASODEX may be associated with changes in your blood which may require your doctor to do certain blood tests.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Very Common (more than 10 in every 100 patients are likely to have them) | |||
| Blood in urine | ✔ | ||
| Abdominal pain | ✔ | ||
| Common (1 to 10 in every 100 patients are likely to have them) | |||
| Yellow skin and eyes (jaundice). These may be symptoms of liver damage | ✔ | ||
| Heart failure (reduced heart function) | ✔ | ||
| Heart attack | ✔ | ||
| Uncommon (1 to 10 in every 1000 patients are likely to have them) | |||
| Serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever. Some patients taking CASODEX 50 mg get an inflammation of the lungs called interstitial lung disease. | ✔ | ||
| Severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing | ✔ | ||
| Rare (1 to 10 in every 10,000 patients are likely to have them) | |||
| increased skin sensitivity to sunlight | ✔ | ||
Tell your doctor or pharmacist if you think you have any of these or any other problems with your tablets.
This is not a complete list of side effects. For any unexpected effects while taking CASODEX, contact your doctor or pharmacist.
How to store
- Keep your tablets in the container they came in.
- Do not take your tablets after the expiry date on the container. Dispose of them in an appropriate way.
- Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.
- Keep your tablets at room temperature (15 to 30°C).
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
NOTE: This CONSUMER INFORMATION leaflet provides you with the most current information at the time of printing.
For the most current information, the Consumer Information
Leaflet plus the full Product Monograph, prepared for health
professionals can be found at:
www.astrazeneca.ca
or by contacting the sponsor, AstraZeneca Canada Inc. at:
Customer Inquiries – 1 (800) 668-6000,
Renseignements – 1 (800) 461-3787
This leaflet was prepared by:
AstraZeneca Canada Inc. Mississauga, Ontario L4Y 1M4
CASODEX® is a registered trademark of AstraZeneca UK Limited, used under license by AstraZeneca Canada Inc.
The AstraZeneca logo is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc.
©AstraZeneca 1995-2017
Last revised: July 13, 2017