Prostate cancer, metastasized

Prostate cancer metastasized in association with castration, medical or surgical

Prostate cancer locally advanced

BICALUTAMIDE INTAS 50 mg film-coated tablet is indicated for patients with locally advanced prostate cancer at high risk of progression of the disease either alone or in adjuvant therapy with radical prostatectomy or Radiotherapy (see section Properties, pharmacodynamics).

Prostate cancer, metastasized

· In adult man, including the elderly, a 50 mg tablet per day, starting with medical or surgical castration.

Prostate cancer locally advanced

· In adult man, including the elderly, three, 50 mg tablets a day .; It is currently recommended to treat 5 years. >
In patients with renal insufficiency or mild hepatic impairment, no dosage adjustment is necessary. In cases of moderate to severe hepatic impairment, accumulation may be observed (see sections 4.3 and 4.4).

Film-coated tablet white, off-white, round, biconvex, engraved "B 50" on one side and with a thickness of 2,90mm ± 0,2mm. >

L 02 BB03 (L, Antineoplastic and Immunomodulatory)

BICALUTAMIDE INTAS 50 mg film-coated tablet is a non-steroidal anti-androgen-receptor-specific, androgenic, devoid of any other endocrine activity.
It induces a regression of prostatic cancer by blocking the activity of androgens in the receptors. Clinically, discontinuation of BICALUTAMIDE INTAS 50 mg film-coated tablets may lead to withdrawal symptoms in some patients

Bicalutamide 150 mg has been studied in patients with cancer, non-metastatic prostate, localized (T1-T2, N0, or NX, M0) or locally advanced (T3-T4, all N, M0, T1-T2 ; N +, M0). It was the subject of a combined analysis of 3, double-blind, placebo-controlled studies involving 8,113 patients. In these studies, bicalutamide 150 mg was given as an immediate hormonal treatment or as adjunctive therapy to radical prostatectomy or radiotherapy (mainly external radiation). At 7.4 years of follow-up, median, 27.4% of patients treated with bicalutamide and 30.7% of patients treated with placebo showed an objective progression of their disease.

A reduction in the risk of progression of the objective disease was observed in most groups of patients but was more pronounced in patients at high risk of progression of the disease. Therefore, clinicians may decide that the optimal medical strategy for a patient at low risk of disease progression, particularly in adjuvant therapy, to radical prostatectomy, or delaying hormone therapy at onset of Signs of progression of the disease.

No difference in overall survival was observed at 7.4 years of follow-up, median with 22.9% mortality (HR '= 0.99, 95% CI 0.91, 1.09). However, trends are visible in the exploratory analyzes of subgroups.

The progression-free survival and overall survival data of patients at the locally advanced stage are summarized in the tables, hereinafter
Table 1: Progression-free survival at the locally advanced stage according to the treatment.

Population analyzed

Events (%) among patients under BICALUTAMIDE

Events (%) among patients taking placebo

Hazard Rati (95% CI)

Abstention surveillance

193/335 (57,6)

222/322 (68,9)

0.60 (0.49 to 0.73)


66/161 (41,0)

86/144 (59,7)

0.56 (0.40 to 0.78)

Radical prostatectomy

179/870 (20,6)

213/849; (25,1)

0.75; (0.61 to 0.91)

Table 2: Overall survival at the stage, locally advanced according to treatment.

Population, analyzed

Deaths (%) among BICALUTAMIDE patients

Deaths (%) among placebo patients

Hazard Ratio (95% CI)

Abstention surveillance

164/335; (49,0)

183/322; (56,8)

0.81 (0.66 to 1.01)


49/161; (30,4)

61/144; (42,4)

0.65 (0.44 to 0.95)

Radical prostatectomy

137/870; (15,7)

122/849 (14,4)

1.09 (0.85 to 1.39)

For patients at the localized stage, treated with bicalutamide alone, there was no significant difference in progression-free survival: in these patients there was also a tendency to decrease survival compared to patients treated On the basis of these results, the benefit / risk ratio of a treatment with BICALUTAMIDE, INTAS 50 mg, film-coated tablet (HR = 1.16, 95% IC 0.99 to 1.37) Is not considered to be favorable in this group of patients.

Bicalutamide is a racemic whose anti-androgenic activity almost exclusively belongs to the (R) -enantiomer.

· Women.

· Children

· Patients who have responded to hypersensitivity to bicalutamide.

· History of hepatic involvement related to taking bicalutamide.

· Severe hepatic insufficiency

Special warnings

·;This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

· A transaminase test should be performed prior to initiation of therapy. The patient will be informed of the need to notify the attending physician immediately in the event of symptoms or signs suggestive of liver damage (see Special Precautions for Use)
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· This check should be repeated periodically during subsequent check-ups. An elevation of serum transaminase activity beyond 3 times the upper limit of normal should stop treatment.

Precautions for use

· In case of clinical signs suggestive of hepatitis (nausea or vomiting, abdominal pain, jaundice or dark urine, pruritus, asthenia, anorexia), transaminases should be assayed immediately. An elevation of transaminases greater than 3 times the upper limit of normal should make definitively stop treatment.

· Bicalutamide is primarily metabolized by the liver. Its elimination is slowed in case of severe hepatic insufficiency. Therefore, it is recommended that BICALUTAMIDE INTAS 50 mg tablet should be used with caution in patients with moderate hepatic impairment

· In vitro studies showed that the (R) enantiomer of bicalutamide was a cytochrome CYP 3A4 inhibitor and to a lesser degree of the cytochromes CYP 2C9, 2C19 and 2D6.

· Coumarinic Anticoagulants: Due to the strong binding to plasma proteins, a competitive interaction was observed in vitro with warfarin.

· It is recommended to regularly check coagulation tests and, if necessary, reduce the dosage of anticoagulant during treatment with BICALUTAMIDE INTAS 50 mg film-coated tablet.

Not applicable.

No cases of overdose have been reported to date. In the absence of an antidote, the treatment should be symptomatic. Due to the strong binding of bicalutamide to plasma proteins and its metabolism, dialysis is not appropriate.
Effects observed during treatment in patients with prostate cancer, locally advanced, at high risk of disease progression, either in treatment alone or in adjuvant therapy, to radical prostatectomy or to; Radiotherapy.

The pharmacological properties of bicalutamide are responsible for certain adverse effects observed.

Among these

Gynecomastia and breast tenderness: the majority of patients receiving BICALUTAMIDE, INTAS (150 mg / day) was concerned with this problem. Clinical experience shows that these effects were found to be severe in 5% of patients. Gynecomastia may stop treatment in some patients in particular after prolonged treatment


Other effects

· Frequently (> 1%) Nausea.
Prostate cancer metastasized prostate cancer metastasized in combination with castration medical or surgical prostate cancer locally advanced BICALUTAMIDE INTAS 50 mg film-coated tablet is indicated in patients with Prostate cancer locally advanced, at high risk of progression of the disease, either in treatment alone or in adjuvant treatment with radical prostatectomy or radiotherapy (see section Properties, pharmacodynamics).