Patient Medication Information: uses, side effects, how to take - AG-Bicalutamide
ABOUT THIS MEDICATION
What the medication is used for:
AG-Bicalutamide 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. AG-Bicalutamide belongs to a group of medicines called non-steroidal anti-androgens. This means that AG-Bicalutamide 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:
- If you have early phase (localized) prostate cancer requiring watchful waiting.
- If you are allergic to bicalutamide or any of the nonmedicinal ingredients in AG-Bicalutamide.
AG-Bicalutamide must not be taken by women, including pregnant women or mothers who are breast feeding their babies.
- AG-Bicalutamide must not be given to children.
What the medicinal ingredient is:
The active ingredient in AG-Bicalutamide is bicalutamide.
What the important nonmedicinal ingredients are:
Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, hypromellose E5, polyethylene glycol 300, povidone K-30, sodium starch glycollate and titanium dioxide.
What dosage forms it comes in:
AG-Bicalutamide comes in tablets containing 50 milligrams (mg) of bicalutamide as the active ingredient.
AG-Bicalutamide comes in blister strips of 15 tablets, 30 tablets per package.
WARNINGS AND PRECAUTIONS
PRECAU
- AG-Bicalutamide should only be prescribed by a doctor experienced with the treatment of prostate cancer.
- AG-Bicalutamide 150mg/day dose should not be used.
- AG-Bicalutamide may rarely be associated with liver failure.
BEFORE you use AG-Bicalutamide talk to your doctor or pharmacist if:
You have previously had a reaction to taking AG-
Bicalutamide or any of the ingredients in the product (see What the Important Nonmedicinal Ingredients Are). As mentioned earlier, your tablets contain lactose and titanium dioxide which may cause a problem in a small number of patients who are sensitive to them.
- You are suffering from any disorder or disease which affects your liver.
- You are suffering from diabetes.
If you go into hospital let the medical staff know you are taking AG-Bicalutamide.
AG-Bicalutamide may make you feel sleepy so you should take care when driving or using machines.
| IMPORTANT: PLEASE READ |
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 if you are taking oral anti-coagulants (to
prevent blood clots)
Please note that these statements may also apply to products used some time ago.
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.
Do not stop taking your tablets even if you are
feeling well, unless your doctor tells you.
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 AG-Bicalutamide, your physician may discontinue AG-Bicalutamide for several weeks in order to monitor your condition off treatment.
Overdose:
If you take more than your normal dose contact your doctor or nearest hospital.
In the event of overdosage, contact your doctor, hospital emergency department or regional Poison Control Centre.
Missed Dose:
You should take AG-Bicalutamide 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, AG-Bicalutamide 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
- 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
Occasionally AG-Bicalutamide may be associated with changes in your blood which may require your doctor to do certain blood tests.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
| Only if severe | In all cases | ||||
| 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. | √ | ||||
| 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 AG- Bicalutamide 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 | √ | ||||
Do not be alarmed by this list of possible events. You may not have any of them.
Tell your doctor or pharmacist if you think you have any of these or any other problems with your tablets.
| IMPORTANT: PLEASE READ |
This is not a complete list of side effects. For any unexpected effects while taking AG-Bicalutamide, contact your doctor or pharmacist.
HOW TO STORE IT
- 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 SUSPECTED SIDE EFFECTS To monitor drug safety, Health Canada through the Canada Vigilance Program, collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance by:
By toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
By online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Health Canada and Food Branch
Health Canada
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor at: 1-866-399-9091
Or at the following address:
Angita Pharma Inc.
1380 – 203 Newton Street Boucherville QC J4B 5H2
Canada