Generic Name/API: bicalutamide

Manufacturer: AstraZeneca

Dosage Forms & Strength & Pack Size:
50 mg tablets, 28’s

Store at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP].



CASODEX 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D metastatic carcinoma of the prostate.

CASODEX 150 mg daily is not approved for use alone or with other treatments.

What is CASODEX?
CASODEX is a prescription medicine called an androgen receptor inhibitor, used in
combination with luteinizing hormone-releasing hormone (LHRH) medicines to treat
Stage D metastatic prostate cancer.
CASODEX 150 mg daily is not approved for use alone or with other treatments.
It is not known if CASODEX is safe and effective in children.


Severe hepatic injury and fatal hepatic failure have been observed. Monitor serum transaminase levels prior to starting treatment with CASODEX, at regular intervals for the first four months of treatment and periodically thereafter, and for symptoms or signs suggestive of hepatic dysfunction. Use CASODEX with caution in patients with hepatic impairment. (5.1)
Hemorrhage with Concomitant Use of Coumarin Anticoagulant. Closely monitor the Prothrombin Time (PT) and International Normalized Ratio (INR), and adjust the anticoagulant dose as needed. (5.2)
Gynecomastia and breast pain have been reported during treatment with CASODEX 150 mg when used as a single agent. (5.3) CASODEX is used in combination with an LHRH agonist. LHRH agonists have been shown to cause a reduction in glucose tolerance in males. Consideration should be given to monitoring blood glucose in patients receiving CASODEX in combination with LHRH agonists. (5.4) Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate for clinical progression if PSA increases.

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