What is Binabic used for?

Bicalutamide 150 mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).

What pharmaceutical form is Binabic available in?

Binabic: Tabletki powlekane 50 mg (doustna)

Is Binabic OTC or prescription only?

Binabic requires a doctor's prescription.

What are the side effects of Binabic?

In this section, undesirable effects are defined as follows: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to ≤1/100); rare (≥ 1/10,000 to ≤1/1,000); very rare (≤ 1/10,000); not known (cannot be estimated from the available data). Table 1 Frequency of Adverse Reactions System Organ Class Frequency Event Blood and the lymphatic system disorders Common Anaemia Immune system disorders Uncommon Hypersensitivity, angioedema and urticaria Metabolism and nutrition disorders Commo

Who should NOT take Binabic?

Bicalutamide 150 mg is contra-indicated in females and children (see section 4.6). Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Co-administration of terfenadine, astemizole or cisapride with bicalutamide is contra-indicated (see section 4.5).

Does Binabic interact with other medications?

In vitro studies have shown that the R-bicalutamide is an inhibitor of CYP 3A4 with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Although clinical studies using antipyrine as a marker of cytochrome P450 (CYP) activity showed no evidence of a drug interaction potential with bicalutamide, mean midazolam exposure (AUC) was increased by up to 80%, after co-administration of bicalutamide for 28 days. For drugs with a narrow therapeutic index such an increase could be

Can Binabic be used during pregnancy?

Pregnancy Bicalutamide is contraindicated in females and must not be given to pregnant women. Breast-feeding Bicalutamide is contraindicated during breast-feeding. Fertility Reversible impairment of male fertility has been observed in animal studies (see section 5.3). A period of subfertility or infertility should be assumed in man.

What precautions should be taken with Binabic?

No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.

What ATC class does Binabic belong to?

Binabic: ATC L02BB03. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Binabic

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Hormone antagonists and related agents, antiandrogens.‍‍‍‍‍‍‍ ATC code: L02BB03. Mechanism of action Bicalutamide is a non-steroidal antiandrogen devoid of other endocrine activity. It binds to androgen receptors without activating gene expression, and thus inhibits the androgen stimulus. Regression of prostatic tumours results from this inhibition. Clinically, discontinuation of bicalutamide can result in 'antiandrogen withdrawal syndrome' in a subset of patients. Clinical efficacy and safety Bicalutamide 150 mg was studied as a treatment for patients with localised (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer in a combined analysis of 3 placebo controlled double-blind studies in 8113 patients, where bicalutamide was given as immediate hormonal therapy or as adjuvant to radical prostatectomy or radiotherapy, (primarily external beam radiation). At 9.7 years median follow up, 36.6% and 38.17% of all bicalutamide and placebo-treated patients, respectively, had experienced objective disease progression. A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression. Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing. No overall survival difference was seen at 9.7 years median follow up with 31.4% mortality (HR=1.01; 95% CI 0.94 to1.09). However, some trends were apparent in exploratory subgroup analyses. Data on progression-free survival and overall survival data over time based on Kaplan-Meier estimates for patients with locally advanced disease are summarised in the following tables: Table 2 Proportion of locally advanced disease patients with disease progression over time by therapy sub-group Analysis population Treatment Arm Events (%) at 3 years Events (%) at 5 years Events (%) at 7 years Events (%) at 10 years Watchful waiting (n=657) Bicalutamide 150 mg 19.7% 36.3% 52.1% 73.2% placebo 39.8% 59.7% 70.7% 79.1% Radiotherapy (n=305) Bicalutamide 150 mg 13.9% 33.0% 42.1% 62.7% placebo 30.7% 49.4% 58.6% 72.2% Radical prostatectomy (n=1719) Bicalutamide 150 mg 7.5% 14.4% 19.8% 29.9% placebo 11.7% 19.4% 23.2% 30.9% Table 3 Overall survival in locally advanced disease by therapy sub-group Analysis population Treatment Arm Events (%) at 3 years Events (%) at 5 years Events (%) at 7 years Events (%) at 10 years Watchful waiting (n=657) Bicalutamide 150 mg 14.2% 29.4% 42.2% 65.0% placebo 17.0% 36.4% 53.7% 67.5% Radiotherapy (n=305) Bicalutamide 150 mg 8.2% 20.9% 30.0% 48.5% placebo 12.6% 23.1% 38.1% 53.3% Radical prostatectomy (n=1719) Bicalutamide 150 mg 4.6% 10.0% 14.6% 22.4% placebo 4.2% 8.7% 12.6% 20.2% For patients with localised disease receiving bicalutamide alone, there was no significant difference in progression free survival. There was no significant difference in overall survival in patients with localised disease who received bicalutamide as adjuvant therapy, following radiotherapy (HR=0.98; 95% CI 0.80 to 1.20) or radical prostatectomy (HR=1.03; 95% CI 0.85 to 1.25). In patients with localised disease, who would otherwise have been managed by watchful waiting, there was also a trend toward decreased survival compared with placebo patients (HR=1.15; 95% CI 1.00 to 1.32). In view of this, the benefit-risk profile for the use of bicalutamide is not considered favourable in patients with localised disease. In a separate programme, the efficacy of Bicalutamide 150 mg for the treatment of patients with locally advanced non-metastatic prostate cancer for whom immediate castration was indicated, was demonstrated in a combined analysis of 2 studies with 480 previously untreated patients with non-metastatic (M0) prostate cancer. At 56% mortality and a median follow-up of 6.3 years, there was no significant difference between bicalutamide and castration in survival (hazard ratio = 1.05 [CI 0.81 to 1.36]); however, equivalence of the two treatments could not be concluded statistically. In a combined analysis of 2 studies with 805 previously untreated patients with metastatic (M1) disease at 43% mortality, Bicalutamide 150 mg was demonstrated to be less effective than castration in survival time (hazard ratio = 1.30 [CI 1.04 to 1.65]), with a numerical difference in estimated time to death of 42 days (6 weeks) over a median survival time of 2 years. Bicalutamide is a racemate with its antiandrogen activity being almost exclusively in the R-enantiomer. Paediatric population No studies have been conducted in paediatric patients (see sections 4.3 and 4.6).

Binabic

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