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bicalutamide 50 mg tablet generic casodex

In stock Manufacturer ACCORD HEALTHCA 16729002310
$0.43 / Tablet

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Uses

Prostate Cancer

Bicalutamide is used in combination with a gonadotropin-releasing hormone (GnRH) luteinizing hormone-releasing hormone analog (e.g., goserelin or leuprolide acetate) for the palliative treatment of metastatic (stage D2) prostate cancer. In a double-blind, multicenter, randomized study in 813 patients with previously untreated advanced prostate cancer, similar survival rate, time to progression, and quality-of-life measurements were reported for bicalutamide (50 mg daily) and flutamide (250 mg 3 times daily) combined with a GnRH analog (goserelin acetate implant or leuprolide acetate depot). For additional information on combined antiandrogenic and GnRH analog therapy, .

Prostate specific antigen (PSA) concentrations should be determined periodically during bicalutamide therapy to monitor therapeutic response, including successful remission or possible progression of cancer. If PSA concentrations increase substantially and consistently during bicalutamide therapy, the possibility of clinical progression should be evaluated. For patients with objective progression of disease and an elevated serum PSA, temporary withdrawal of bicalutamide therapy may be considered. Withdrawal of bicalutamide in such patients can be associated with a decrease in PSA. The mechanism of this response to bicalutamide withdrawal has not been determined, but may involve the development of mutations at the androgen receptor.

Dosage and Administration

Patients should be advised of the possibility of facial flushing during bicalutamide therapy and that alcohol could exacerbate this effect. Patients who experience such intolerance during therapy with the drug should avoid alcohol consumption.

Administration

Bicalutamide is administered orally without regard to meals.

Dispensing and Administration Precautions

Dispensing errors have occurred because of similarity in spelling between Casodex (the trade name for bicalutamide) and Kapidex (the former trade name for dexlansoprazole, a proton-pump inhibitor). Therefore, in April 2010, the manufacturer of Kapidex changed the trade name for dexlansoprazole from Kapidex to Dexilant to avoid future dispensing errors. The potential exists for serious adverse effects to occur if patients receive the incorrect drug (see Dosage and Administration: Dosage). Some experts recommend that pharmacists assess measures of avoiding dispensing errors and implement them as appropriate (e.g., by using computerized name alerts, matching the prescribed drug with the patient's medical history, verifying orders for these drugs) and that clinicians consider including the intended use of the drug on the prescription.

Dosage

The safety and efficacy of bicalutamide have not been established in women or children. Bicalutamide is not intended for use in women and should not be used in women, particularly for nonserious or nonlife-threatening conditions. In addition, bicalutamide is contraindicated in women who are or may became pregnant.

Prostate Cancer

For use in combination with a gonadotropin-releasing hormone (GnRH) analog in the palliative treatment of metastatic (stage D2) prostate cancer, the usual dosage of bicalutamide is 50 mg once daily in the morning or evening. Treatment with bicalutamide and the GnRH analog should be initiated concomitantly, and bicalutamide should be taken at the same time each day. The duration of combined therapy with bicalutamide and a GnRH analog depends on the clinical response of the patient. Periodic monitoring of serum prostate specific antigen (PSA) may be useful for assessing the patient's response to therapy. For patients with objective progression of disease and an elevated serum PSA, temporary withdrawal of bicalutamide therapy while continuing therapy with the GnRH analog may be considered.

Discontinuance of Therapy for Hepatic Toxicity

Severe liver injury, in some cases leading to hospitalization and/or death, has been reported rarely in association with bicalutamide therapy. Hepatotoxicity generally occurred within the first 3-4 months of bicalutamide therapy. Hepatitis or marked increases in serum concentrations of hepatic transaminases leading to discontinuance of bicalutamide therapy were reported in 1% of patients receiving the drug in controlled clinical trials.

Serum transaminase concentrations should be measured prior to initiation of bicalutamide therapy, at regular intervals during the first 4 months of treatment, and periodically thereafter. If clinical signs or symptoms suggestive of liver dysfunction (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, '' flu-like'' symptoms, dark urine, jaundice, or right upper quadrant tenderness) occur, serum transaminase (especially ALT) concentrations should be measured immediately. Bicalutamide should be discontinued immediately in any patient who develops jaundice or an increase in serum ALT concentration to greater than 2 times the upper limit of normal, and liver function should be monitored closely.

Dosage in Renal and Hepatic Impairment

No adjustment of bicalutamide dosage is necessary in patients with renal impairment. Bicalutamide is extensively metabolized in the liver; however, the pharmacokinetics of the drug do not appear to be altered in patients with mild to moderate hepatic impairment, and no dosage adjustment is required in such patients. Limited pharmacokinetic data indicate that bicalutamide elimination may be delayed in patients with severe hepatic impairment, and the manufacturer states that the drug should be used with caution in patients with moderate to severe hepatic impairment. While no specific recommendations are made regarding modification of bicalutamide dosage in patients with moderate to severe hepatic impairment, the manufacturer states that periodic tests of liver function should be considered in patients with hepatic impairment receiving long-term therapy with the drug. Serum transaminase concentrations should be measured prior to initiation of bicalutamide therapy, at regular intervals during the first 4 months of treatment, and periodically thereafter in all patients receiving bicalutamide.(See Dosage: Discontinuance of Therapy for Hepatic Toxicity under Dosage and Administration.)

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