Bicaprost (Tablets) Instructions for Use

Marketing Authorization Holder

Dr. Reddy’s Laboratories Ltd. (India)

ATC Code

L02BB03 (Bicalutamide)

Active Substance

Bicalutamide (Rec.INN registered by WHO)

Dosage Form

Bicaprost

Film-coated tablets, 50 mg: 28, 30, or 50 pcs.

Dosage Form, Packaging, and Composition

7 pcs. – blisters made of PVC/PVDC/aluminum foil (4) – cardboard packs.
10 pcs. – blisters made of PVC/PVDC/aluminum foil (3) – cardboard packs.
10 pcs. – blisters made of PVC/PVDC/aluminum foil (5) – cardboard packs.

Clinical-Pharmacological Group

Antiandrogenic drug with antitumor activity

Pharmacotherapeutic Group

Antineoplastic agent, antiandrogen

Pharmacological Action

Bicalutamide is a nonsteroidal antiandrogen. By binding to receptors with affinity for androgens, it suppresses the activity of androgens, resulting in regression of prostate tumors. 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 the tablet at the same time each day, with or without food.

Use Bicaprost only in combination with a GnRH analogue or following surgical castration for the treatment of prostate cancer.

Do not adjust the dosage unless instructed by a physician.

In patients with moderate to severe hepatic impairment, use with extreme caution due to the risk of drug accumulation.

Perform regular monitoring of liver function before and during treatment.

Discontinue therapy immediately if severe hepatic changes occur.

Continue treatment as directed by the treating oncologist.

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, hair regrowth, itching, dry skin.

Other: hematuria.

Contraindications

Concomitant use with terfenadine, astemizole, cisapride; pediatric age, 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 administration 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 administration should be discontinued.

Drug Interactions

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

With the concomitant 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 liver microsomal 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.