Bicalutamid-BP

Bicalutamidum

Each tablet contains bicalutamide 150 mg. Excipient with known effect: lactose monohydrate, sodium.

Each tablet contains bicalutamide 50 mg. Excipient with known effect: lactose monohydrate, sodium.

Indication: Bicalutamide-BP 150 mg: indicated as monotherapy or as adjuvant treatment to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk of disease progression, in whom combined hormonal therapy is not considered appropriate because of associated adverse reactions or is not accepted by the patient. Bicalutamide-BP 50 mg: indicated for the treatment of advanced prostate cancer in combination with LHRH analogue therapy or surgical castration.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
− Bicalutamide-BP is contraindicated in women and children (see section 4.6).
− Bicalutamide-BP must not be given to patients with a hypersensitivity reaction to the active substance or to any of the excipients listed in section 6.1.
− Concomitant administration of Bicalutamide-BP with terfenadine, astemizole or cisapride is contraindicated (see section 4.5).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Treatment should be initiated under the direct supervision of a specialist. Bicalutamide is extensively metabolised in the liver. There is evidence to suggest that elimination may be slower in subjects with severe hepatic impairment, which could lead to accumulation of bicalutamide. Bicalutamide-BP should therefore be administered with caution to patients with moderate to severe hepatic impairment. Periodic liver function tests should be considered because of the possibility of hepatic changes. Most changes are expected to occur within the first 6 months of treatment with Bicalutamide-BP. Severe hepatic changes and hepatic failure have rarely been observed during bicalutamide therapy, and fatal outcomes have also been reported (see section 4.8). If […]