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Details for: APO-BICALUTAMIDE

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02296063APO-BICALUTAMIDEBICALUTAMIDE50 MGTABLETORAL
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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

APO-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. APO-BICALUTAMIDE belongs to a group of medicines called non-steroidal anti-androgens. This means that Apo- 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
  • Do not take APO-BICALUTAMIDE if you have early phase (localized) prostate cancer requiring watchful waiting.
  • Do not take APO-BICALUTAMIDE if you are allergic to bicalutamide or any of the nonmedicinal ingredients in APO-BICALUTAMIDE.
  • APO-BICALUTAMIDE must not be taken by women, including pregnant women or mothers who are breast feeding their babies.
  • APO-BICALUTAMIDE must not be given to children.
What the medicinal ingredient is

The active ingredient in APO-BICALUTAMIDE is bicalutamide

What the non-medicinal ingredients are

APO-BICALUTAMIDE 50 mg tablets contains the following nonmedicinal ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium and magnesium stearate.

What dosage form it comes in

APO-BICALUTAMIDE comes in tablets containing 50 milligrams (mg) of bicalutamide as the active ingredient.

APO-BICALUTAMIDE comes in blister strips of 15 tablets, 30 tablets per package.

Warnings and precautions

Serious Warnings and Precautions

  • Apo-Bicalutamide should only be prescribed by a doctor experienced with the treatment of prostate cancer.
  • Apo-Bicalutamide 150mg/day dose should not be used.
  • Apo-Bicalutamide may rarely be associated with liver failure; some cases have been fatal.
  • Apo-Bicalutamide may be associated with uncommon cases of interstitial lung disease; some cases have been fatal.

Before you use APO-BICALUTAMIDE 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 are taking blood thinners or medicines to prevent blood clots.
  • 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 APO-BICALUTAMIDE.

If you go into hospital let the medical staff know you are taking APO-BICALUTAMIDE.

If you are taking APO-BICALUTAMIDE, you and/or your partner should use birth control while you are taking APO-BICALUTAMIDE and for at least 130 days after stopping APO-BICALUTAMIDE. Talk to your doctor if you have any questions about birth control.

APO-BICALUTAMIDE may have an effect on male fertility which could be reversible.

Avoid direct exposure to excessive sunlight or UVlight while you are taking APO-BICALUTAMIDE.

APO-BICALUTAMIDE 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 blood thinners like warfarin or medicines 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 APO-BICALUTAMIDE, your physician may discontinue APO-BICALUTAMIDE for several weeks in order to monitor your condition off treatment.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

You should take APO-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, APO-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):

  • 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 APO-BICALUTAMIDE may be associated with changes in your blood which may require your doctor to do certain blood tests.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and call 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 APO-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   ✔  
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 APO-BICALUTAMIDE, 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 °C to 30 °C). Protect from light.
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:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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

If you want more information about APO-BICALUTAMIDE:

This leaflet can also be found at:
http://www.apotex.ca/products.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Last revised: December 06, 2018

Date modified: