Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2018 Publisher: Douglas Pharmaceuticals Ltd, PO Box 45 027, Auckland 0651, New Zealand, Phone: (09) 835 0660
Treatment of advanced prostate cancer in combination with GnRH (LHRH) agonist therapy or surgical castration.
Prevention of disease flare associated with the use of LHRH agonists.
One tablet (50 mg) once a day.
Treatment with BICALOX should be started at the same time as treatment with a GnRH (LHRH) agonist or surgical castration.
BICALOX is contraindicated in children.
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).
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.
For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).
36 months.
Store at or below 25°C. Protect from light and moisture.
PVC/PVdC-Aluminium blisters: 28, 30, 56, 98 tablets.
HDPE bottle: 100, 500 tablets.
Not all pack types or sizes may be marketed.
No special requirements.
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