Bicalutamide (Tablets) Instructions for Use

Instructions
Dosage forms

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

An antiandrogenic nonsteroidal 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 intensively metabolized in the liver by oxidation and formation of glucuronide conjugates.

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

Accumulation of bicalutamide in the body is possible.

Indications

Prescribe exclusively for the treatment of prostate cancer.

Use only as a component of combination therapy.
Administer concurrently with a gonadotropin-releasing hormone (GnRH) analogue.
Alternatively, administer concurrently with or following surgical castration.

ICD codes

Open the list of 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.

Administer one 50 mg tablet orally once daily.

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

For combination therapy with a GnRH analogue, initiate both treatments on the same day.

Continue treatment as directed; do not adjust the dose without medical supervision.

In patients with moderate to severe hepatic impairment, exercise caution due to risk of accumulation.

Adverse Reactions

Monitor for hot flashes, breast pain, and gynecomastia, which are very common endocrine effects.

Observe for nausea, diarrhea, and abdominal pain from the digestive system. Regularly monitor liver function tests for elevated transaminases; severe hepatic reactions including jaundice and fatal cholestasis are possible.

Be aware of asthenia, depression, and decreased libido. Dermatological reactions such as dry skin, pruritus, and alopecia may occur. Hematuria has been reported.

Contraindications

Do not use in patients with known hypersensitivity to bicalutamide or any excipient of the formulation.
Contraindicated for concomitant use with terfenadine, astemizole, or cisapride due to risk of serious cardiac events.
Do not administer to women, particularly those who are or may become pregnant.
Not for use in pediatric 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

Be aware that bicalutamide can increase the AUC of midazolam by 80%, indicating inhibition of CYP3A4. Use caution with other CYP3A4 substrates.

Potentiation of effects or adverse reactions is possible with concurrent use of cyclosporine or calcium channel blockers.

Theoretically, inhibitors of microsomal liver enzymes may increase bicalutamide plasma concentrations, potentially increasing adverse reactions.

In vitro, bicalutamide displaces warfarin from protein binding sites; monitor INR closely if co-administered.

Overdose

No specific antidote exists. Suspect overdose in cases of unresponsiveness or worsening adverse reactions, particularly hepatic effects.

Manage with symptomatic and supportive care. Consider gastric lavage if ingestion was recent.

Monitor liver function closely. Hemodialysis is unlikely to be effective 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

Bicalutamide [Biocad, JSC (Russia)]
Film-coated tablets, 50 mg: 28 or 30 pcs.

Marketing Authorization Holder

Biocad, JSC (Russia)

Manufactured By

Jiangsu Tasly Diyi Pharmaceutical, Co., Ltd. (China)

Dosage Form

Bicalutamide

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

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, with an engraving “50” on one side; the cross-section of the tablet is white.

	1 tab.
Bicalutamide	50 mg

Excipients : lactose monohydrate – 61 mg, sodium carboxymethyl starch – 7.5 mg, povidone – 5 mg, magnesium stearate – 1.5 mg.

Shell composition film coating – 3.8 mg (macrogol – 13.33%, titanium dioxide – 20%, hypromellose – 66.67%).

14 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

Bicalutamide [Biocad, JSC (Russia)]
Film-coated tablets, 50 mg: 28 or 30 pcs.

Marketing Authorization Holder

Biocad, JSC (Russia)

Dosage Form

Bicalutamide

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

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, with an engraving “50” on one side; the cross-section of the tablet is white.

	1 tab.
Bicalutamide	50 mg

Excipients : lactose monohydrate – 61 mg, sodium carboxymethyl starch – 7.5 mg, povidone – 5 mg, magnesium stearate – 1.5 mg.

Shell composition film coating – 3.8 mg (macrogol – 13.33%, titanium dioxide – 20%, hypromellose – 66.67%).

14 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

Bicalutamide [Biocad, JSC (Russia)]
Film-coated tablets, 50 mg: 28 or 30 pcs.

Marketing Authorization Holder

Biocad, JSC (Russia)

Manufactured By

Beijing Yiling Bioengineering And Technology Co., Ltd. (China)

Dosage Form

Bicalutamide

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

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex, with an engraving “50” on one side; the cross-section of the tablet is white.

	1 tab.
Bicalutamide	50 mg

Excipients : lactose monohydrate – 61 mg, sodium carboxymethyl starch – 7.5 mg, povidone – 5 mg, magnesium stearate – 1.5 mg.

Shell composition film coating – 3.8 mg (macrogol – 13.33%, titanium dioxide – 20%, hypromellose – 66.67%).

14 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.

Bicalutamide [Ozon Medica, LLC (Russia)]
Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, or 300 pcs.
Film-coated tablets, 150 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, or 300 pcs.

Marketing Authorization Holder

Ozon Medica, LLC (Russia)

Dosage Forms

	Bicalutamide	Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, or 300 pcs.
		Film-coated tablets, 150 mg: 10, 20, 30, 40, 50, 60, 90, 100, 120, 150, 180, or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Bicalutamide	50 mg

Excipients : lactose monohydrate – 29.5 mg, microcrystalline cellulose (MCC-101) – 10.3 mg, sodium carboxymethyl starch – 4 mg, povidone K17 – 4 mg, magnesium stearate – 0.7 mg, purified water – 1.5 mg.

Film coating composition: hypromellose – 1.65 mg, titanium dioxide – 0.9 mg, macrogol-4000 – 0.45 mg.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (4) – cardboard packs.
30 pcs. – blister packs (5) – cardboard packs.
30 pcs. – blister packs (6) – cardboard packs.
30 pcs. – blister packs (10) – cardboard packs.

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Bicalutamide	150 mg

Excipients : lactose monohydrate – 88.5 mg, microcrystalline cellulose (MCC-101) – 30.9 mg, sodium carboxymethyl starch – 12 mg, povidone K17 – 12 mg, magnesium stearate – 2.1 mg, purified water – 4.5 mg.

Film coating composition: hypromellose – 4.95 mg, titanium dioxide – 2.7 mg, macrogol-4000 – 1.35 mg.

Bicalutamide [Technology Lekarstv LLC (Russia)]
Film-coated tablets, 50 mg: 7, 28, or 30 pcs.

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

Dosage Form

Bicalutamide

Film-coated tablets, 50 mg: 7, 28, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Bicalutamide	50 mg

7 pcs. – blister packs (1) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Bicalutamide [Technology Lekarstv LLC (Russia)]
Film-coated tablets, 150 mg: 7, 28, or 30 pcs.

Marketing Authorization Holder

Technology Lekarstv LLC (Russia)

Dosage Form

Bicalutamide

Film-coated tablets, 150 mg: 7, 28, or 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Bicalutamide	50 mg

7 pcs. – blister packs (1) – cardboard packs.
28 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.

Bicalutamide [Pharmasintez-Nord, JSC (Russia)]
Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, or 100 pcs.
Film-coated tablets, 150 mg: 10, 20, 30, 40, 50, or 100 pcs.

Marketing Authorization Holder

Pharmasintez-Nord, JSC (Russia)

Dosage Forms

	Bicalutamide	Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, or 100 pcs.
		Film-coated tablets, 150 mg: 10, 20, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white, round, biconvex; with a score on one side; the cross-section shows a white or almost white core.

	1 tab.
Bicalutamide	50 mg

Excipients : lactose monohydrate – 135 mg, povidone K30 – 4 mg, magnesium stearate – 2 mg, sodium carboxymethyl starch – 8 mg, colloidal silicon dioxide – 1 mg.

Film coating composition: hypromellose – 1.6 mg, macrogol – 0.8 mg, talc – 0.8 mg, titanium dioxide – 0.8 mg.

10 pcs. – blister packs (1) – cardboard packs^x.
10 pcs. – blister packs (2) – cardboard packs^x.
10 pcs. – blister packs (3) – cardboard packs^x.
10 pcs. – blister packs (4) – cardboard packs^x.
10 pcs. – blister packs (5) – cardboard packs^x.
10 pcs. – blister packs (10) – cardboard packs^x.

^x a self-adhesive label made of label paper, writing paper, or polymer materials may be affixed to the pack

Film-coated tablets white, round, biconvex; the cross-section shows a white or almost white core.

	1 tab.
Bicalutamide	150 mg

Excipients : lactose monohydrate – 397 mg, povidone K30 – 10 mg, magnesium stearate – 6 mg, sodium carboxymethyl starch – 24 mg, colloidal silicon dioxide – 3 mg.

Film coating composition: hypromellose – 4 mg, macrogol – 2 mg, talc – 2 mg, titanium dioxide – 2 mg.

^x a self-adhesive label made of label paper, writing paper, or polymer materials may be affixed to the pack

Bicalutamide Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 150 mg: 10, 14, 28, 30, or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Bicalutamide Canon

Film-coated tablets, 150 mg: 10, 14, 28, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Bicalutamide	150 mg

Excipients : corn starch 107 mg, croscarmellose sodium 19.5 mg, lactose monohydrate 132.9 mg, povidone 7.6 mg, sodium stearyl fumarate 3 mg.

Film coating composition: Opadry II white 12 mg.

7 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
7 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (6) – cardboard packs.
15 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.

Bicalutamide Canon [Canonpharma Production, CJS (Russia)]
Film-coated tablets, 50 mg: 10, 14, 28, 30, or 60 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Form

Bicalutamide Canon

Film-coated tablets, 50 mg: 10, 14, 28, 30, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex.

	1 tab.
Bicalutamide	50 mg

Excipients: corn starch 35 mg, croscarmellose sodium 6.5 mg, lactose monohydrate 44.3 mg, povidone 3.2 mg, sodium stearyl fumarate 1 mg.

Film coating composition: Opadry II white 4 mg.

7 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
7 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (6) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.

Bicalutamide Grindex [Grindeks, JSC (Latvia)]
Film-coated tablets, 50 mg: 30 pcs.

Marketing Authorization Holder

Grindeks, JSC (Latvia)

Dosage Form

Bicalutamide Grindex

Film-coated tablets, 50 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Bicalutamide	50 mg

10 pcs. – contour cell packaging (3) – cardboard packs.

Bicalutamide Kabi [Fresenius Kabi Deutschland, GmbH (Germany)]
Film-coated tablets, 50 mg: 20, 28, 30, 40, 50, 56, or 60 pcs.

Marketing Authorization Holder

Fresenius Kabi Deutschland, GmbH (Germany)

Manufactured By

Fresenius Kabi Oncology, Limited (India)

Dosage Form

Bicalutamide Kabi

Film-coated tablets, 50 mg: 20, 28, 30, 40, 50, 56, or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with an engraving “DB01” on one side and smooth on the other side; on cross-section – the tablet core is white.

	1 tab.
Bicalutamide	50 mg

Excipients: lactose monohydrate – 88.93 mg, sodium starch glycolate – 5 mg, colloidal silicon dioxide – 0.45 mg, povidone – 4.5 mg, magnesium stearate – 1.12 mg.

Coating composition Opadry white (Y-1-7000) – 3.75 mg (hypromellose 5 cP – 2.344 mg, titanium dioxide – 1.172 mg, macrogol 400 – 0.234 mg).

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (4) – cardboard packs.

Bicalutamide Sandoz [Sandoz, d.d. (Slovenia)]
Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Bicalutamide Sandoz

Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Bicalutamide	50 mg

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (7) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Bicalutamide Sandoz [Sandoz, d.d. (Slovenia)]
Film-coated tablets, 150 mg: 10, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, or 100 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Bicalutamide Sandoz

Film-coated tablets, 150 mg: 10, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Bicalutamide	150 mg

7 pcs. – blisters (4) – cardboard packs.
7 pcs. – blisters (8) – cardboard packs.
7 pcs. – blisters (12) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (7) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Bicalutamide Sandoz [Sandoz, d.d. (Slovenia)]
Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Sandoz, S.A. (Argentina)

Dosage Form

Bicalutamide Sandoz

Film-coated tablets, 50 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Bicalutamide	50 mg

Bicalutamide Sandoz [Sandoz, d.d. (Slovenia)]
Film-coated tablets, 150 mg: 10, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, or 100 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Sandoz, S.A. (Argentina)

Dosage Form

Bicalutamide Sandoz

Film-coated tablets, 150 mg: 10, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets	1 tab.
Bicalutamide	150 mg

Medixlife (Author)

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