Prostate cancer, metastasized

Prostate cancer metastasized in association with castration, medical or surgical

Prostate cancer locally advanced

Bicalutamide is indicated in patients with prostate cancer locally advanced, at high risk of progression of the disease, either in treatment alone or as adjunctive therapy to radical prostatectomy or radiotherapy (see ; Pharmacodynamic properties).

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, white, off-white, round, biconvex tablet with "ZE57" printed in black on one side

ANTIANDROGENES, Code, ATC

L 02 BB03 (L, Antineoplastic and Immunomodulatory)

Bicalutamide is a non-steroidal anti-androgen, androgen receptor, devoid of any other endocrine activity.


Bicalutamide (bicalutamide) 150 mg has been studied in patients with non-metastatic prostate cancer, localized (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, all N, M0, T1 -T2, N +, M0). It was analyzed by a combination of 3 double-blind, placebo-controlled studies involving 8113 patients. In these studies, bicalutamide 150 mg was given as either immediate hormone therapy or adjuvant therapy, radical prostatectomy or radiotherapy (mainly external irradiation). At 7.4 years of median follow-up, 27.4% of patients treated with bicalutamide and 30.7% of patients treated with placebo showed an objective progression of their disease.
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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 treatment.

Population, analyzed

Events (%) among patients under BICALUTAMIDE

Events (%) among patients taking placebo

Hazard Ratio (95% CI)

Abstention surveillance

193/335; (57,6)

222/322; (68,9)

0.60 (0.49 to 0.73)

Radiotherapy

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)

Radiotherapy

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, but there was also a tendency for a decrease in survival compared with patients treated with Bicalutamide alone By placebo (HR = 1.16, 95% IC 0.99 to 1.37). Based on these results, the benefit / risk ratio of Bicalutamide treatment is not considered favorable In this group of patients.

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


· 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).
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· 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 in subsequent checks and checks. 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 be used with caution in patients with moderate hepatic impairment.
· 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 the coagulation tests and to reduce the dosage of the anticoagulant, if necessary, during treatment with bicalutamide.

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 who received bicalutamide (150 mg / day) were 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

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Other effects

· Frequently (> 1%) Nausea.
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Prostate cancer Metastasis Prostate cancer Metastasized in combination with castration Medical or surgical Prostate cancer locally advanced Bicalutamide is indicated in patients with prostate cancer locally , Advanced, at high risk of progression of the disease, either in treatment alone or in adjuvant therapy with radical prostatectomy or radiotherapy (see section "Properties, Pharmacodynamics"). >