Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK
Casodex 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
Casodex 150 mg is also indicated for the management of patients with locally advanced, non-metastatic prostate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable.
Adult males including the elderly: The dosage is one 150 mg tablet to be taken orally once a day.
Casodex 150 mg should be taken continuously for at least 2 years or until disease progression.
No dosage adjustment is necessary for patients with renal impairment.
No dosage adjustment is necessary for patients with mild hepatic impairment. Increased accumulation may occur in patients with moderate to severe hepatic impairment (see section 4.4).
Casodex is contraindicated for use in children (see section 4.3).
There is no human experience of overdosage. There is no specific antidote; treatment should be symptomatic. Dialysis may not be helpful, since bicalutamide is highly protein bound and is not recovered unchanged in the urine. General supportive care, including frequent monitoring of vital signs, is indicated.
Shelf life: 4 years.
Do not store above 30°C.
PVC/Aluminium foil blister pack comprising strips of 5, 10 and 14 tablets to give pack sizes of 10, 20, 30, 40, 50, 80, 90, 100, 200 or 14, 28, 56, 84, 140 and 280 tablets.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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