Bicana (Tablets) Instructions for Use

ATC Code

L02BB03 (Bicalutamide)

Active Substance

Bicalutamide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiandrogenic drug with antitumor activity

Pharmacotherapeutic Group

Antineoplastic hormonal preparations and hormone antagonists; hormone antagonists and related compounds; antiandrogens

Pharmacological Action

Bicalutamide is a nonsteroidal antiandrogen agent. By binding to receptors with affinity for androgens, it suppresses the activity of androgens, resulting in regression of the prostate tumor.

It does not possess other types of endocrine activity.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. Food intake does not affect bioavailability.

Plasma protein binding is 96%.

It is extensively metabolized in the liver by oxidation and glucuronide conjugation.

It is excreted as metabolites in urine and bile in approximately equal proportions.

Accumulation of bicalutamide in the body is possible.

Indications

Prostate cancer – as part of combination therapy with a GnRH analogue or with surgical castration.

ICD codes

Dosage Regimen

Take one 50 mg tablet once daily.

Administer this medication as part of a combination therapy with a gonadotropin-releasing hormone (GnRH) analogue or following surgical castration.

Take the tablet at the same time each day, with or without food.

Swallow the tablet whole with a glass of water; do not crush or chew it.

In cases of moderate to severe hepatic impairment, use with caution due to potential for drug accumulation.

Continue treatment as long as clinical benefit is observed, unless unacceptable adverse reactions occur.

Do not adjust the dosage without specific medical instruction.

Adverse Reactions

Endocrine system: hot flashes, breast tenderness and gynecomastia, decreased libido.

Digestive system: abdominal pain, diarrhea, nausea, vomiting, increased transaminase levels, jaundice, cholestasis.

Central nervous system: asthenia, depression are possible.

Dermatological reactions: alopecia, restoration of hair growth, itching, dry skin.

Other: hematuria.

Contraindications

Concomitant use with terfenadine, astemizole, cisapride; childhood, hypersensitivity to bicalutamide.

Not prescribed for female patients.

Use in Pregnancy and Lactation

Not prescribed for female patients.

Use in Hepatic Impairment

Use with caution in patients with moderate and severe hepatic impairment, as accumulation of bicalutamide in the body is possible.

Regular monitoring of liver function is required during treatment. In case of severe changes, bicalutamide should be discontinued.

Pediatric Use

The drug is not prescribed to children.

Special Precautions

Use with caution in patients with moderate and severe hepatic impairment, as accumulation of bicalutamide in the body is possible.

Regular monitoring of liver function is required during treatment. In case of severe changes, bicalutamide should be discontinued.

Drug Interactions

When bicalutamide was used for 28 days against the background of midazolam administration, the AUC of midazolam increased by 80%.

With simultaneous use of bicalutamide with cyclosporine or calcium channel blockers, potentiation or development of adverse reactions is possible.

Theoretically, an increase in the plasma concentration of bicalutamide is possible with its simultaneous use with inhibitors of microsomal liver enzymes, which may be accompanied by an increased frequency of adverse reactions.

In vitro studies have shown that bicalutamide can displace the coumarin anticoagulant warfarin from plasma protein binding sites.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.