Indications
- Advanced prostate cancer in combination with a GnRH analog (gonadotropin-releasing hormone) or surgical castration;
- locally advanced prostate cancer (T3-T4, any N, M0; T1-T2, N+, M0) as monotherapy or adjuvant therapy in combination with radical prostatectomy or radiotherapy;
- locally advanced, non-metastatic prostate cancer in cases where surgical castration or other medical interventions are not applicable or appropriate.
Use during pregnancy and breastfeeding
Pregnancy. The drug is contraindicated in women and should not be prescribed to pregnant women.
Breastfeeding. The drug is contraindicated during breastfeeding.
Fertility. Animal studies have shown reversible impairment of fertility in males. In men, temporary subfertility 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.
With caution
- in case of moderate to severe liver dysfunction;
- in patients with known risk factors for QT prolongation or taking drugs that prolong the QT interval;
- when used simultaneously with cyclosporine or “slow” blockers calcium channels, with drugs that inhibit microsomal oxidation of drugs (cimetidine and ketoconazole), with drugs predominantly metabolized with the participation of the CYP3A4 isoenzyme;
- with lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
