What Is Casodex (Bicalutamide)? FDA Approval, Turkish Authorization, and Reimbursement

• FDA Approved: Yes (initial approval: October 4, 1995)
• Pack Name: Casodex
• Active Ingredient Name: Bicalutamide
• Administration Method: Oral (by mouth)
• Class: Antiandrogen
• Category: Hormonal medicine
• Manufacturer: AstraZeneca
• Turkish Distribution: AstraZeneca
• Approved Cancers: Locally advanced or metastatic prostate cancer.

What Is Casodex?

Bicalutamide is a nonsteroidal antiandrogen. It binds androgen receptors, blocking androgen uptake and androgen binding in prostate cancer cell nuclei. This mechanism suppresses tumor growth.

How Does It Work?

• Androgen Receptor Binding: Binds androgen receptors and prevents androgen binding.
• Androgen Affinity: Bicalutamide has 4 times greater affinity for androgen receptors than flutamide.

FDA (United States Food and Drug Administration) Approval History 

• October 4, 1995:
  • The FDA approved Casodex with LHRH analogs for Stage D2 metastatic prostate cancer.
• November 6, 2008:
  • Casodex received an additional indication for early-stage prostate cancer. This indication was subsequently withdrawn.
• December 20, 2011:
  • The FDA announced the availability of generic Casodex for marketing with the same treatment indications.

Authorization in Turkey

Casodex's licensed therapeutic indications in Turkey are stated as follows:

Therapeutic Indications

Casodex 150 mg is used alone or as adjuvant treatment to radical prostatectomy or radiotherapy in locally advanced prostate cancer with a high risk of progression.

Casodex 150 mg is also for locally advanced, nonmetastatic prostate cancer in which surgical castration or other medical interventions are unsuitable or unacceptable and have not been performed.

Is Casodex Reimbursed?

The Turkish Social Security Institution (SGK) reimburses it for patients diagnosed with prostate cancer.

Price

As of December 2025, the pharmacy retail price of Casodex 50 mg is 715.88 TL, and that of 150 mg film-coated tablets is 2190.20 TL.

What Is Bicalutamide's Status on the List of Off-Label Medicines Usable Without Additional TİTCK Approval?

Metastatic Adenoid Cystic Carcinoma: Suitable for line 2 and beyond in androgen receptor–positive metastatic disease.

Resistance Mechanisms

• Reduced Androgen Receptor Expression
  • Reduced cellular androgen receptor expression can disable the mechanism targeted by Casodex, allowing tumor cells to develop resistance.
• Androgen Receptor Mutations
  • Androgen receptor mutations may reduce Casodex's ability to bind the receptor, lowering effectiveness and allowing tumor cells to continue growing.

Pharmacokinetic Properties

• Absorption
  • Peak plasma concentrations occur 1-2 hours after oral administration. Food does not affect absorption. The half-life is long, lasting several days.
• Distribution
  • Plasma protein binding is 96%.
• Metabolism
  • Metabolized in the liver by cytochrome P450 enzymes. Metabolites are excreted in urine and feces.

Drug Interactions

• Interaction with Warfarin: Care is needed in patients taking anticoagulants such as warfarin. Casodex may displace warfarin from protein-binding sites and increase its anticoagulant effect. Coagulation parameters (PT and INR) should be monitored regularly, with warfarin dose adjustment when needed.

Precautions

• Liver Function: Use cautiously in patients with impaired liver function. Liver function tests (LFTs) should be checked regularly before and during treatment.
• Hot Flashes: Patients should be informed about possible hot flashes during treatment. The following may be considered for prevention and/or treatment:
  • Clonidine (0.1 - 0.2 mg PO daily)
  • Megestrol acetate (20 mg PO twice daily)
  • Soy tablets (1 tablet PO three times daily)
• Sexual Function and Impotence: Patients should be informed about the risk of impaired sexual function and impotence during treatment.
• Pregnancy Category D: Casodex is contraindicated in pregnancy because of the risk of fetal harm. Use while breastfeeding is also not recommended.

Side Effects

• Hot flashes, reduced libido, impotence, gynecomastia, breast pain, and galactorrhea (in 50% of patients).
• Constipation (in 10% of patients).
• Nausea, vomiting, and diarrhea are rare.
• Transient increases in serum transaminases are rare.