Patient Medication Information: uses, side effects, how to take - Nu-Bicalutamide
ABOUT THIS MEDICATION
What the medication is used for:
NU-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 tumor growth within the prostate. NU-BICALUTAMIDE belongs to a group of medicines called non-steroidal anti-androgens. This means that NU- Bicalutamide interferes with some of the actions of androgens to prevent the tumor 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 NU-BICALUTAMIDE.
NU-BICALUTAMIDE must not be taken by women, including pregnant women or mothers who are breast feeding their babies.
- NU-BICALUTAMIDE must not be given to children.
What the medicinal ingredient is:
The active ingredient in NU-BICALUTAMIDE is Bicalutamide
What the important nonmedicinal ingredients are:
NU-BICALUTAMIDE 50 mg tablets contains the following nonmedicinal ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium and magnesium stearate.
What dosage forms it comes in:
NU-BICALUTAMIDE comes in tablets containing 50 milligrams (mg) of bicalutamide as the active ingredient.
WARNINGS AND PRECAUTIONS
- NU-Bicalutamide should only be prescribed by a doctor experienced with the treatment of prostate cancer.
- NU-Bicalutamide 150mg/day dose should not be used.
- NU-Bicalutamide may rarely be associated with liver failure.
Before you use NU-BICALUTAMIDE talk to your doctor or pharmacist if:
You have previously had a reaction to
taking NU-BICALUTAMIDE or any of the ingredients in the product (see What the Important Nonmedicinal Ingredients Are). As mentioned earlier, your tablets contain lactose 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.
If you go into hospital let the medical staff know you are taking NU-BICALUTAMIDE.
Your tablets are unlikely to adversely affect your ability to drive a car or to operate machinery.
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 NU-BICALUTAMIDE, your physician may discontinue NU-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.
Missed Dose:
You should take NU-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, NU-BICALUTAMIDE 50 mg can have side effects.
Side effects that are very common (more than 10 in every 100 patients are likely to have them):
- tender or enlarged breast tissue
- hot flushes
Side effects that are common (1 to 10 in every 100 patients are likely to have them):
- nausea
- diarrhoea
- itching
- feeling weak
Side effects that are rare (1 to 10 in every 10,000 patients are likely to have them):
- vomiting
- dry skin
Occasionally NU-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 | ||
| 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 NU-BICALUTAMIDE 50 mg | √ | ||
| 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 | ||
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 | √ | ||
Yellow skin and eyes (jaundice). These may be symptoms of liver damage. | √ | ||
Do not alarmed by this list of possible events. You may not have any of them.
Tell you 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 NU-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). Protect from light.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health product to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free to 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 0701C Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you should require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Nu-Pharm Inc. at:
1-800-267-1438