Indications
Advanced prostate cancer in combination with a GnRH analog (gonadotropin-releasing hormone) or surgical castration;
locally advanced prostate cancer (T3-T4, any H, M0; T1-T2, H+, M0) as monotherapy or adjuvant therapy in combination with radical prostatectomy or radiation therapy;
locally advanced non-metastatic prostate cancer in cases where surgical castration or other medical interventions are inapplicable or inappropriate.
Use during pregnancy and lactation
Pregnancy. The drug is contraindicated in women and should not be prescribed to pregnant women.
Breast-feeding. The drug is contraindicated during breastfeeding.
Fertility. Animal studies have shown reversible impairment of fertility in males. In men, temporary infertility or infertility should be expected.
Contraindications
Hypersensitivity to bicalutamide and auxiliary components of the drug.
Simultaneous use with terfenadine, astemizole and cisapride.
Bicalutamide should not be prescribed to children and women.
Lactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Carefully
with moderate and severe liver dysfunction;
in patients with known risk factors for prolongation of the QT interval or taking drugs that prolong the QT interval;
when used simultaneously with cyclosporine or “slow” calcium channel blockers, with drugs that inhibit microsomal oxidation of drugs (cimetidine and ketoconazole), with drugs that are metabolized primarily with the participation of the CYP3A4 isoenzyme;
with lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
