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Casodex Dosage

Casodex Dosage

Indications & Dosage

CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) for the treatment of Stage D2 metastatic .

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

Dosage And Administration

Recommended Dose And Schedule

The recommended dose for CASODEX therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that CASODEX be taken at the same time each day. Treatment with CASODEX should be started at the same time as treatment with an LHRH analog. If a dose of CASODEX is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Dosage Adjustment In Renal Impairment

No dosage adjustment is necessary for patients with renal impairment.

Dosage Adjustment In Hepatic Impairment

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide, no dosage adjustment is necessary.

Recommended Dose and Schedule

The recommended dose for CASODEX therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that CASODEX be taken at the same time each day. Treatment with CASODEX should be started at the same time as treatment with an LHRH analog. If a dose of CASODEX is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

Dosage Adjustment in Hepatic Impairment

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment.

50 mg PO once daily. Treatment with bicalutamide should be started at the same time as treatment with a LHRH analog. A multicenter, double-blind, controlled clinical trial compared bicalutamide and flutamide, each in combination with LHRH analogues (e.g., goserelin acetate implant or leuprolide acetate depot). At a median of 160 weeks of therapy, 52.7% of the bicalutamide-LHRH analogue therapy arm and 57.5% of the flutamide-LHRH analogue therapy arm had died [NS]. No significant difference in quality of life parameters was noted between treatment arms.

Case reports suggest 50 mg PO once every other day is effective; additionally a lower dose of 1—2 doses/week has also been successful. In 2 patients (both with sickle cell anemia), an initial dose of 50 mg PO once daily eliminated stuttering priapism; due to financial reasons or adverse effects (e.g., gynecomastia), the dose was reduced to 50 mg PO every other day with continued successful prevention of priapism. The patient experiencing gynecomastia further reduced his dosage to 50 mg PO 1—2 times/week with success.

 A third patient, with a spinal cord injury, experienced complete elimination of priapism after initiating therapy with 50 mg PO every other day. All 3 patients have been treated chronically (i.e., > 2 years) without recurrence of priapism or significant adverse effects; all 3 patients are able to engage in sexual activity. The American Urological Association recommends antiandrogen therapy as a first-line option in the prevention of stuttering priapism; however, do not use bicalutamide in patients who have not achieved full sexual maturation and adult stature.

Dosing Considerations

Hepatic Impairment

No dosage adjustment guidelines are available. Bicalutamide should not be used in patients with jaundice or elevated ALT levels.

Renal Impairment

No dosage adjustment needed.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Bicalutamide is usually taken once per day in the morning or evening. You may take the medicine with or without food. Try to take the medication at the same time each day.

Bicalutamide is given as part of a combination prostate cancer treatment with another medicine called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. These medicines prevent the testicles from producing testosterone.

Treatment with bicalutamide and LHRH is usually started at the same time. Follow your doctor's instructions.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor's instructions.

You should not stop using bicalutamide unless your doctor tells you to.

While using bicalutamide, you may need frequent blood tests.

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

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