CASODEX, 150 mg bicalutamide, tablet, 150 mg

Abbreviated Core Data Sheet

See local Prescribing Information for full details, as Prescribing Information may vary from country to country.

Indications:

Patients with locally advanced prostate cancer as immediate therpy either alone or as adjuvant to treatment of curative intent.

Patients with non-metastatic prostate cancer for whom immediate hormonal therapy is indicated.

Patients with metastatic prostate cancer for whom surgical or medical castration is not indicated or not acceptable.

Dosage:

Adult males, including the elderley: 150 mg, once daily.

Children: not recommended.

Contraindications:

CASODEX 150 mg is contra-indicated in females and children.

CASODEX 150 mg must not be given to any patient who has shown a hypersensitivity reaction to its use.

Warnings and precautions:

CASODEX 150 mg should be used with caution in patients with moderate to severe hepatic impairment.

Interactions:

Although in vitro studies have suggested the potential for CASODEX to inhibit cytochrome 3A4, a number of clinical studies show the magnitude of any inhibition is unlikely to be of clinical significance.

When CASODEX 150 mg is started in patients who are already receiving coumarin anticoagulants, prothrombin time should be closely monitored.

Pregnancy and lactation:

CASODEX 150 mg is contra-indicated in females and must not be given to pregnant women or nursing mothers.

Undesirable effects:

As a result of its pharmacological action: Breast tenderness, gynaecomastia, hot flushes, pruritus, asthenia, alopecia, hair regrowth, dry skin, decreased libido, impotence and weight gain.

Other observed side effects: abdominal pain, depression, dyspepsia, nausea, haematuria and interstitial lung disease.

Hypersensitivity reactions: including angioneurotic oedema and urticaria.

Hepatic changes (elevated transaminases, jaundice), rarely severe, may occur and periodic liver function tests should be considered. Hepatic failure has been observed rarely. Casodex 150 mg should be discontinued if changes are severe.

Pharmacodynamic properties:

CASODEX 150 mg is a non-steriodal antiandrogen, devoid of other endocrine activity. It binds to androgen receptors without activating gene expression, and thus inhibits the androgen stimulus. Regression of prostatic tumours results from this inhibition.

Further information is available on request from local AstraZeneca subsidiaries.

CASODEX is a trademark of the AstraZeneca group.

Revision date: 11 May 2006