Treatment of prostate cancer, advanced in combination with an analogue of the hormone releasing luteinizing hormone (LH-RH) or with surgical castration. Br>
Men, adults, including elderly

One tablet once a day at the same time each day (usually morning or evening).
Treatment should begin in the week prior to the initiation of an LH-RH analogue or at the time of surgical castration.
Renal insufficiency

There is no need to adjust dosage in patients with renal impairment

Hepatic Insufficiency

It is not necessary to adapt the dosage in case of mild hepatic insufficiency

In patients with mild to severe hepatic impairment, an accumulation of bicalutamide may occur (see Warnings and Precautions for Use).
Children and adolescents

Bicalutamide is contraindicated in children (see Contraindications).

Biconvex film-coated tablet, white to whitish in color, marked "93" engraved on one side and "220;" on the other side.
Pharmacotherapeutic group, ANTIANDROGENES, ATC code: L 02 BB03

Bicalutamide is a non-steroidal anti-androgen free of any other endocrine activity. It binds to androgen receptors without activating gene expression and thus inhibits androgen stimulation. This inhibition leads to regression of prostatic tumors. In some patients, discontinuation of treatment may lead to withdrawal syndrome and anti-androgens.

Bicalutamide is a racemic, the anti-androgenic activity is essentially due to the (R) -enantiomer.


· Hypersensitivity to bicalutamide or to any of the excipients (see section Composition).
· Bicalutamide is contraindicated in women and children (see section Pregnancy and lactation).

· Concomitant administration of terfenadine, astemizole and cisapride (see section 4.4 Interactions with other medicinal products and other forms of interaction).
Initiation of treatment should be done under the direct supervision of a specialist.
Bicalutamide is highly metabolized by the liver. Available evidence suggests that elimination may be slower in patients with severe hepatic impairment, which may result in a greater accumulation of the drug. Therefore, caution should be exercised when administering bicalutamide to patients with moderate to severe hepatic impairment

Hepatic function should be tested regularly due to potential liver changes

In most cases, these changes occur within the first 6 months of treatment with bicalutamide.


It has been shown that bicalutamide inhibits cytochrome P450 (CYP; 3A4). Caution should be exercised when administered concomitantly with medicinal products predominantly metabolized by CYP 3A4 (see sections Contraindications and Interactions with other medicinal products and other forms of interaction)
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A decrease in glucose tolerance was observed in men receiving LH-RH agonists. This can be manifested by diabetes or loss of blood sugar control, in men with pre-existing diabetes. The control of blood glucose should therefore be considered in patients receiving bicalutamide and LH-RH agonists.

This product contains 35 mg lactose monohydrate.

Patients with rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.
There is no evidence of a possible pharmacodynamic or pharmacokinetic interaction between bicalutamide and LH-RH analogs.
In vitro studies indicate that the (R) enantiomer of bicalutamide is an inhibitor of cytochrome CYP 3A4 and has lower inhibitory effects on cytochromes CYP 2C9, 2C19 and 2D6. >

Although clinical studies using antipyrin as a marker of cytochrome P450 (CYP) activity have not revealed any potential drug interactions, with bicalutamide, the increase in mean exposure to Midazolam (AUC) may be up to 80% after co-administration of bicalutamide for 28 days. Such an increase may have clinical repercussions for narrow therapeutic margin drugs. Therefore concomitant administration of terfenadine, astemizole and cisapride is contraindicated (see section 4.3) and caution should be exercised in the event of concomitant use of cyclosporine or inhibitors; Calcium. It may be necessary to decrease the dosage of these drugs, especially if there are signs of increased or undesirable effect. In the case of treatment with ciclosporin, close monitoring of plasma concentrations and clinical condition when initiating or discontinuing treatment with bicalutamide is recommended.

Caution should be exercised in the case of concomitant administration of medicinal products capable of inhibiting the oxidation of bicalutamide, ie medicinal products containing ketoconazole or cimetidine. Such concomitant administration could theoretically increase the plasma concentrations of bicalutamide, which could theoretically lead to an increase in undesirable effects.

In vitro studies have shown that bicalutamide can displace warfarin, a coumarin anticoagulant, from its binding sites to proteins. It is therefore recommended that the rapid time after the initiation of treatment with bicalutamide in patients treated with coumarin anticoagulants should be monitored regularly and regularly.
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Not applicable.

There are no data on overdosage in humans. There is no specific antidote and the treatment should be symptomatic. Hemodialysis may not be useful because bicalutamide is highly protein bound and is not recovered and unchanged in the urine. It is advisable to administer general supportive treatment with frequent monitoring of vital functions.


In this section, adverse events are defined as follows: very common (≥ 1/10), frequent (≥ 1/100,

Hematologic and lymphatic system disorders

Very common: Anemia
Immune system disorders

Uncommon: Hypersensitivity, angioneurotic edema and urticaria

Metabolism and nutrition disorders

Common: Decreased appetite.

Psychiatric disorders

Common: Decline in libido, depression.

Disorders of the nervous system

Very common: Dizziness.

Common: Somnolence.
Affections, vascular

Very common, Hot flushes

Respiratory, thoracic and mediastinal disorders

Uncommon: Pneumonitis, interstitial a (fatal outcomes have been reported)

Gastrointestinal disorders

Very common: Abdominal pain, constipation, nausea

Common: Dyspepsia, flatulence.
Hepatobiliary disorders

Common: hepatotoxicity, jaundice, hypertransaminaseemia b.

Rare: Hepatic insufficiency (fatal outcomes have been reported) c.

Skin and subcutaneous tissue disorders

Common: Alopecia, hirsutism / hair regrowth, dryness of the skin, pruritus, skin rashes

Kidney and urinary tract disorders

Very common Hematuria

Diseases of the reproductive and breast organs

Very common: Gynecomastia, sensitivity, mammary d.

Common: erectile dysfunction.

Disorders, general and administration site abnormalities

Very common: Asthenia, edema.
Common: Thoracic pain.
Cardiac disorders

Common: myocardial infarction (fatal outcomes have been reported), heart failure e.

Investigations

Common: Weight gain

Listed as an adverse effect following post-marketing data review. The frequency was determined from the frequency of undesirable effects of interstitial pneumonitis reported during the period of randomized treatment of EPC studies carried out with the 150 mg dosage.
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B Changes in liver function are rarely severe, are often transient, and disappear or improve with continued or discontinued treatment.
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C Listed as an adverse effect following analysis of post-marketing data. The frequency was determined from the frequency of adverse reactions of hepatic insufficiency reported in patients receiving treatment with the 150 mg dose of bicalutamide during the open period of the EPC studies. Br>

D These effects can be reduced by concomitant castration

E observed in a pharmaco-epidemiological study with the LHRH agonists and the anti-androgens used in the treatment of prostate cancer. The risk appeared to be increased when the 50 mg dose of bicalutamide was used in combination with LHRH agonists but no increase in risk was demonstrated when the dosage of 150 mg of bicalutamide in Monotherapy has been used to treat prostate cancer

Treatment of prostate cancer, advanced in combination with an analogue of the hormone releasing luteinizing hormone (LH-RH) or with surgical castration. Br>