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A drug for the treatment of locally advanced prostate cancer.
Monotherapy or adjuvant therapy, in combination with a gonadotropin-releasing hormone analog or surgical castration, for advanced prostate cancer. Treatment of 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. Treatment of locally advanced non-metastatic prostate cancer when surgical castration or other drugs are ineffective or unacceptable.
Antineoplastic agent - antiandrogen.
It is an antitumor agent, a non-steroidal antiandrogenic drug - a competitive antagonist of endogenous androgens. By binding to receptors on the surface of target organ cells, the drug makes them inaccessible to androgens, while increasing the concentration of hormones in the plasma.
The result is a regression of prostate neoplasms. The use of bicalutamide at a dose of 150 mg / day in patients with localized (T1-T2, N0 or NX, MO) or locally advanced (T3-T4, any N, M0; any T, N +, M0) prostate cancer reduces the risk of disease progression and the relative risk of bone metastasis. At the same time, the effectiveness of bicalutamide in terms of survival rates is lower than that when performing surgical castration. In some patients, discontinuation of the drug may lead to the development of antiandrogen withdrawal syndrome (after withdrawal in 10-15% of patients, temporary stabilization of the disease occurs).
Hypersensitivity to bicalutamide or other components of the drug. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption. Women. Childhood. Simultaneous reception with terfenadine, astemizole and cisapride. With caution: in case of impaired liver function.
1. Adult men, including the elderly: For advanced prostate cancer in combination with an analogue of gonadotropin-releasing hormone or surgical castration: by mouth, 50 mg once a day.
2. With locally advanced prostate cancer: inside, 150 mg once a day. Bicalutamide should be taken continuously for at least 2 years. If signs of disease progression appear, the drug should be discontinued.
3. Impaired renal function. No dose adjustment is required. Liver dysfunction. In case of mild liver dysfunction, dose adjustment is not required. In patients with moderate and severe liver dysfunctions, accumulation of the drug may be observed - dose adjustment is required.
Immune system disorders: rarely - hypersensitivity reactions, including angioedema, urticaria, skin rash. Endocrine system disorders: very often - gynecomastia (it can persist even after stopping therapy, especially if the drug is taken for a long time), breast tenderness; often - decreased sex drive, erectile dysfunction, weight loss or increase, hyperglycemia, diabetes mellitus. Disturbances from the nervous system: often - asthenic syndrome, dizziness, insomnia or drowsiness, anxiety, loss of appetite, rarely - depression, "flushes" of blood to the face.
Heart disorders: often - angina pectoris, development or worsening of heart failure, increased blood pressure.
Disturbances from the respiratory system, chest and mediastinal organs: rarely - chest pain, cough, pharyngitis, bronchitis, pneumonia, interstitial pulmonary diseases (including fatal), rhinitis.
Disturbances from the gastrointestinal tract: often - nausea; rarely - abdominal pain, dyspepsia, constipation, diarrhea, vomiting, flatulence, gastric bleeding, dryness of the oral mucosa.
Violations of the liver and biliary tract: rarely - a transient increase in the activity of "hepatic" transaminases, cholestasis, jaundice; very rarely - liver failure (including fatal).
Skin and subcutaneous tissue disorders: often - alopecia, hirsutism or hair regrowth, dry skin.
Musculoskeletal and connective tissue disorders: often myasthenia gravis, myalgia, convulsions, arthritis, joint contractures.
Renal and urinary tract disorders: infrequently - dysuria, polyuria, urinary retention, peripheral edema; rarely - hematuria.
General disorders and disorders at the injection site: often - fever, flu-like syndrome, chills, increased sweating, pain in the pelvic region. Laboratory and instrumental data: often: anemia.
Cases of overdose with this drug in humans have not been described. There is no specific antidote. Overdose treatment is symptomatic, monitoring of vital body functions is necessary. Hemodialysis is ineffective, since bicalutamide strongly binds to plasma proteins and is not excreted unchanged in the urine.
There are no data on pharmacokinetic or pharmacodynamic interactions between bicalutamide and gonadotropin-releasing hormone analogues. In vitro studies have shown that the (R) -enantiomer of bicalutamide inhibits CYP 3A4, to a lesser extent affecting the activity of CYP isoenzymes 2C9, 2C19, 2D6. In clinical studies using phenazone as a marker of cytochrome P450 (CYP) activity, no potential drug interaction with other drugs was found, however, when bicalutamide was used for 28 days while taking midazolam, the area under the concentration-time curve of midazolam increased by 80%.
The simultaneous use of bicalutamide with drugs such as terfenadine, astemizole and cisapride is contraindicated. Caution should be exercised when using bicalutamide concomitantly with cyclosporine, a "slow" calcium channel blocker; drugs that inhibit liver microsomal enzymes, for example, with cimetidine or ketoconazole (a dose reduction of these drugs may be required).
Concomitant use can lead to an increase in the concentration of bicalutamide in plasma and, possibly, to an increase in the incidence of side effects. The drug enhances the effect of indirect coumarin anticoagulants, including warfarin (competition for protein binding).
It is recommended to regularly monitor the prothrombin time when prescribing bicalutamide to patients receiving indirect coumarin anticoagulants.
The drug should be stored in a dry, dark place at a temperature not exceeding 25 ° C. Keep out of the reach of children.
2 years. Do not use Bicalutamide after its expiration date.
In stationary city pharmacies, the drug is sold only with a doctor's prescription.