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Casodex 150 mg Fact Sheet

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Important Safety Information -
Accelerated deaths in localized prostate cancer patients, undergoing watchful waiting and therapy with Casodex« 150 mg.

This fact sheet notifies the Canadian public on the results of an analysis of a large on-going study of CASODEX 150 mg used in localized prostate cancer patients. These results show that in a subgroup of 1627 patients with early (localized) prostate cancer there is an increase in the number of deaths (196 versus 174) in the CASODEX 150 mg treated patients compared to those receiving no active therapy (placebo).

What should patients who are taking CASODEX 150 mg do?

Patients on CASODEX 150 mg (3 x 50 mg pills) daily are advised to discuss treatment discontinuation with their physician.

This information does not affect patients taking CASODEX 50 mg daily for metastatic prostate cancer.

What is CASODEX?

CASODEX is an anti-androgen that interferes with testosterone stimulating prostate cancer cells. It has been developed at a dose of 150 mg (3 x 50mg tablets) daily for early stage prostate cancer.

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

CASODEX comes in blister packs of 15 tablets, 30 tablets per package.

What is early prostate cancer?

In the early stages, prostate cancer is confined to the prostate gland (localized disease). As the disease progresses, the cancer spreads to other tissues within the pelvis (locally advanced disease) and eventually to other parts of the body (advanced or metastatic prostate cancer).

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.

For further information

Customer inquiries at 1-800-668-6000
Casodex« is a trademark of the AstraZeneca group of companies.