Prostate cancer, metastasized

Prostate cancer metastasized in association with castration, medical or surgical

Prostate cancer locally advanced

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

Metastasized Prostate Cancer

· In adult men, including the elderly, one 50 mg tablet per day, to start with medical or surgical castration. Code>
Prostate cancer locally advanced

· In adult men, 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).

The tablet should be swallowed with a glass of water. One tablet per day at the same time each day.


(L: Antineoplastic and Immunomodulators)

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

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 to 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 bicalutamide

Events (%) among patients under placebo

Hazard Ratio (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 is no significant difference in progression-free survival. "In these patients, there is also a tendency to decrease survival compared to patients; Treated with placebo (HR = 1.16, 95% CI 0.99 to 1.37). Based on these results, the benefit-risk ratio of bicalutamide therapy is not considered 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 liver disease associated with taking bicalutamide

· Hepatic impairment, severe

Special warnings

Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases). Br>

A transaminase control should be performed prior to initiation of therapy. The patient will be informed of the need to immediately notify the attending physician of any symptoms or signs suggestive of liver damage (see Precautions, Specific Uses).

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, pain, 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 essentially metabolized by the liver. Its elimination is slowed in case of severe hepatic insufficiency. Therefore, caution should be exercised in the use of bicalutamide in patients with moderate hepatic impairment

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

+ Anticoagulants of type coumarinic

Due to the strong binding to plasma proteins, a competitive-type 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


Other effects

· Frequently (> 1%) Nausea.