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Bilumid® (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 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 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

  • Use for the treatment of prostate cancer exclusively as a component of combination therapy.

Administer concurrently with a gonadotropin-releasing hormone (GnRH) analogue or in conjunction with surgical castration to achieve complete androgen blockade.

ICD codes

ICD-10 code Indication
C61 Malignant neoplasm of prostate
ICD-11 code Indication
2C82.Y Other specified malignant neoplasms of the prostate gland
2C82.Z Malignant neoplasms of prostate, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

The standard adult dosage is one 50 mg tablet administered orally once daily.

Take the tablet at the same time each day, with or without food. Continue this regimen as a component of combination therapy unless disease progression or unacceptable toxicity occurs.

Adverse Reactions

Observe for hot flashes, breast tenderness, and gynecomastia, which are very common endocrine effects. Monitor for asthenia and other general disorders.

Frequently monitor liver function tests due to the risk of hepatitis and elevated transaminases. Discontinue therapy if severe hepatic changes occur. Gastrointestinal disturbances like nausea, diarrhea, and abdominal pain are common.

Other reactions include hematuria, decreased libido, dermatological effects such as alopecia, dry skin, and pruritus.

Contraindications

  • Do not use in patients with a known hypersensitivity to bicalutamide or any component of the formulation.
  • Strictly contraindicated for concomitant use with terfenadine, astemizole, or cisapride due to the risk of serious cardiac events.
  • This drug is absolutely contraindicated in women, particularly during pregnancy or lactation, due to potential teratogenic effects.
  • Do not administer to pediatric patients as safety and efficacy have not been established.

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

Exercise caution with concomitant use of drugs metabolized by CYP3A4, such as midazolam, as bicalutamide may increase their plasma concentration.

Monitor patients closely when co-administering with cyclosporine or calcium channel blockers due to the potential for potentiation of adverse effects.

Be aware that inhibitors of microsomal liver enzymes may increase bicalutamide levels, potentially increasing the frequency of adverse reactions. Bicalutamide may displace coumarin anticoagulants from protein binding sites; monitor INR accordingly.

Overdose

No specific antidote exists. Suspected overdose requires immediate symptomatic and supportive care.

Perform gastric lavage if ingestion was recent. Closely monitor vital signs and provide appropriate clinical support. Dialysis is unlikely to be beneficial due to high protein binding.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Veropharm, JSC (Russia)

Dosage Forms

Bottle Rx Icon Bilumid® Film-coated tablets, 50 mg: 28 or 30 pcs.
Film-coated tablets, 150 mg: 28 or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex; a cross-section shows two layers, the inner layer is white or almost white.

1 tab.
Bicalutamide 50 mg

Excipients : lactose monohydrate – 55.7 mg, potato starch – 30.8 mg, microcrystalline cellulose – 8 mg, primogel (sodium starch glycolate) – 4.8 mg, povidone – 8 mg, magnesium stearate – 1.6 mg, colloidal silicon dioxide – 1.1 mg.

Shell composition hypromellose – 2.15 mg, povidone – 1.35 mg, polysorbate (tween-80) – 0.45 mg, talc – 0.6 mg, titanium dioxide – 0.4 mg, quinoline yellow dye (E104) – 0.05 mg.

7 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets yellow, round, biconvex; a cross-section shows two layers, the inner layer is white or almost white.

1 tab.
Bicalutamide 150 mg

Excipients : lactose monohydrate – 167.1 mg, potato starch – 92.4 mg, microcrystalline cellulose – 24 mg, primogel (sodium starch glycolate) – 14.4 mg, povidone – 24 mg, magnesium stearate – 4.8 mg, colloidal silicon dioxide – 3.3 mg.

Shell composition hypromellose – 6.45 mg, povidone – 4.05 mg, polysorbate (tween-80) – 1.35 mg, talc – 1.8 mg, titanium dioxide – 1.2 mg, quinoline yellow dye (E104) – 0.15 mg.

7 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Veropharm, JSC (Russia)

Dosage Form

Bottle Rx Icon Bilumid® Sugar-coated tablets, 150 mg: 28 or 30 pcs.

Dosage Form, Packaging, and Composition

Coated tablets yellow, round, biconvex shape; a cross-section shows two layers.

1 tab.
Bicalutamide 150 mg

Excipients : lactose, potato starch, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, colloidal silicon dioxide.

Shell composition hypromellose, povidone, polysorbate, talc, titanium dioxide, yellow water-soluble dye or quinoline yellow.

7 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
28 pcs. – bottles (1) – cardboard packs.
28 pcs. – jars (1) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.

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