Description
Bicana Pharmacodynamics
Bicalutamide, an antitumor agent, is a racemic mixture with
non-steroidal antiandrogenic activity of predominantly the (R)-enantiomer, has no
has no other endocrine activity. Bicalutamide binds to androgen
receptors on the surface of target organ cells, inhibits the stimulating
effects of androgens without activating gene expression. As a result, regression of
of malignant tumors of the prostate gland. In some patients.
Discontinuing bicalutamide can lead to the development of clinical syndrome
“of anti-androgen withdrawal.
Indications
Prostate cancer:
? treatment of advanced prostate cancer in combination with analogue
Gonadotropin-releasing hormone (GnRH analog) or surgical castration;
? monotherapy or adjuvant therapy in combination with radical prostatectomy
or radiotherapy for locally advanced prostate cancer (T3-T4,
any N, M0; T1-T2, N+, M0);
? treatment of locally advanced, non-metastatic prostate cancer
In cases where surgical castration or other medical interventions
are unacceptable or inapplicable.
Contraindications
Hypersensitivity to bicalutamide or any other component
of the drug.
Simultaneous use of terfenadine, astemizole and cisapride.
Bicalutamide is contraindicated in children and women.
Caution
Lactose intolerance, lactase deficiency and glucose-galactose malabsorption
(because the drug contains lactose); hepatic impairment; concomitant use
with cyclosporine or “slow” calcium channel blockers; concomitant
concomitant use with drugs that inhibit microsomal oxidation of drugs
drugs (cimetidine or ketoconazole).
Dosage and administration
- Orally, with plenty of fluids after meals.
- The drug is indicated for adult men (including elderly men).
- In advanced prostate cancer – orally, 50 mg once a day, in
Combined with a simultaneous initiation of treatment with a GnRH analogue or surgical
castration. - For locally advanced non-metastatic prostate cancer, 150 mg
once daily. - Bicalutamide should be taken long-term, for at least 2 years.
- If there are signs of disease progression, the drug should be
stop taking it. - Renal dysfunction: no dose adjustment is required.
Liver dysfunction: in patients with mild liver dysfunction - Dose adjustment is not required. In patients with moderate or severe hepatic impairment
increased cumulation of bicalutamide is possible in patients with moderate or severe liver dysfunction, therefore the drug
should be used with caution.
