Prostate cancer, metastasized

Prostate cancer metastasized in association with castration, medical or surgical

Prostate cancer locally advanced

BICALUTAMIDE ISOMED is indicated in patients with prostate cancer locally advanced, at high risk of progression of the disease, either alone or in adjuvant therapy with radical prostatectomy or radiotherapy (see section ; Pharmacodynamic properties).

Prostate cancer, metastasized

In adult men, including the elderly, one 50 mg tablet per day, to begin with medical or surgical castration.

Prostate cancer locally advanced

In the adult man, including the elderly, three tablets of 50 mg per day. It is currently recommended to treat 5 years.

In patients with renal insufficiency or mild hepatic impairment, no dosage adjustment is necessary. In case of moderate to severe hepatic impairment, accumulation may be observed (see sections 4.3 and 4.4).

White film-coated, round, biconvex engraved "BCM 50" on one side.

Class: Pharmacotherapeutic: ANTIANDROGENES, ATC Code, L02BB03.

(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, is to postpone hormone treatment at the 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 bicalutamide patients

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 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% IC 0.99 to 1.37). Based on these results, the benefit-risk ratio of bicalutamide therapy is not considered As 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

Transaminase control should be performed prior to initiation of treatment. The patient will be informed of the need to immediately notify the attending physician in the event of symptoms or signs suggestive of liver damage (see Warnings and Precautions / Job search).
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.

Due to the presence of lactose, this drug is contraindicated in cases of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.

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. A higher transaminase elevation at 3 times the upper limit of normal should permanently discontinue 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

This medicine contains lactose and is not recommended for use in patients with galactose intolerance, Lapp lactase deficiency or malabsorption syndrome, glucose or galactose (hereditary or rare diseases). Br>

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

+ Anticoagulants of the coumarin type

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, if necessary, the dosage of the anticoagulant 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 metastasized prostate cancer metastasized in combination with castration medical or surgical prostate cancer locally advanced BICALUTAMIDE ISOMED 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"). >