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Casodex (bicalutamide)


Nonsteroidal antiandrogen




For use in combination w/ a luteinizing hormone-releasing hormone (LHRH) analogue for treatment of stage D2 metastatic carcinoma of the prostate.


D2 Metastatic Prostate Carcinoma

Combination w/ Luteinizing Hormone-Releasing Hormone (LHRH) Analogue:
50mg qd (am or pm) at the same time as LHRH analogue

Missed Dose

If a dose is missed, take the next dose at the scheduled time; do not take the missed dose and do not double the next dose


Oral route

Take w/ or w/o food
Take at the same time each day


Tab: 50mg


Women, pregnancy.


Death or hospitalization due to severe liver injury (hepatic failure) reported. Hepatitis or marked increases in liver enzymes leading to discontinuation reported. Measure serum ALT immediately if signs/symptoms of liver dysfunction occur; d/c immediately w/ close follow-up of liver function if jaundice occurs or ALT rises >2X ULN. Reduction in glucose tolerance reported. Regularly assess serum prostate-specific antigen (PSA) to monitor response; evaluate for clinical progression if PSA levels rise during therapy. For patients w/ objective disease progression w/ an elevated PSA, consider a treatment period free of antiandrogen while continuing the LHRH analogue. Caution w/ moderate-severe hepatic impairment.


Pain, hot flashes, asthenia, infection, back pain, constipation, nausea, diarrhea, anemia, peripheral edema, dizziness, dyspnea, rash, nocturia, hematuria.


Can displace coumarin anticoagulants from binding sites; closely monitor PT and consider anticoagulant dose adjustment. Caution w/ CYP3A4 substrates. May increase levels of midazolam.


Category X, not for use in nursing.


Nonsteroidal antiandrogen; inhibits the action of androgens by binding to cytosol androgen receptors in target tissue.


Absorption: Well-absorbed; Cmax=0.768µg/mL; Tmax=31.3 hrs. Distribution: Plasma protein binding (96%). Metabolism: Liver via oxidation and glucuronidation. Elimination: Urine, feces; T1/2=5.8 days.


Assess for drug hypersensitivity, diabetes, hepatic impairment, and possible drug interactions. Measure serum transaminase levels.


Measure serum transaminase levels at regular intervals for the first 4 months of treatment, then periodically thereafter. Measure serum ALT for signs/symptoms of liver dysfunction. Monitor LFTs in hepatically impaired patients on long-term therapy. Regularly monitor serum PSA levels.  Monitor blood glucose levels.


Advise not to interrupt or d/c medication w/o consulting physician. Inform that somnolence may occur; advise to use caution when driving or operating machinery. Advise to monitor blood glucose levels while on therapy. Inform that photosensitivity has been reported during treatment; advise to avoid direct exposure to excessive sunlight or UV-light exposure and to consider using sunscreen.


20-25°C (68-77°F).


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