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Click chart to enlarge
*Based on a multicenter, randomized, controlled clinical trial comparing TRELSTAR LA to TRELSTAR Depot (active comparator) in patients with advanced (stage C/D) prostate cancer (n=346). Investigators and patients were blinded to the treatment assignment at time of enrollment.
Maintains Mean Testosterone Levels Below 20 ng/dL
- Mean testosterone concentrations between months 2 and 9 did not exceed 8.1 ng/dL
in patients treated with TRELSTAR Depot and 12.4 ng/dL in patients treated
with TRELSTAR LA [1,2]
- 96.4% of patients treated with TRELSTAR Depot and 94.4% treated with TRELSTAR
LA had no escape from castrate testosterone levels (no values above 50 ng/dL) during
months 2 through 9 [3,4]
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References:
1. Data on file, Watson Laboratories, Inc. DEB-96-TRI-01 (second phase) Clinical Study Report; June 1999. 2. Data on file, Watson Laboratories, Inc. DEB-96-TRI-01 (first phase) Clinical Study Report; July 1999. 3. TRELSTAR Depot full Prescribing Information, Watson Pharma, Inc. 4. TRELSTAR LA full Prescribing Information, Watson Pharma, Inc.
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Indications and Usage
TRELSTAR® Depot and TRELSTAR® LA are indicated in
the palliative treatment of advanced prostate cancer. TRELSTAR Depot and TRELSTAR
LA offer an alternative treatment for prostate cancer when orchiectomy or estrogen
administration are either not indicated or unacceptable to the patient.
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Safety Information
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The most commonly reported adverse events associated with the use of TRELSTAR Depot/TRELSTAR
LA included hot flushes (58.6%/73.0%), skeletal pain (12.1%/13.2%), impotence (7.1%/2.3%),
headache (5.0%/6.9%), leg pain (2.1%/5.2%), and edema in legs (0.0%/6.3%) . TRELSTAR
is contraindicated in women who are or may become pregnant as well as patients who
are hypersensitive to triptorelin, other LHRH agonists, or LHRH . Infrequent postmarketing
reports of anaphylactic shock and angioedema have been received since 1986 (global
experience) . As with all LHRH agonists, triptorelin causes an initial transient
increase in testosterone levels. Patients may experience the onset or exacerbation
of symptoms during this period, including bone pain, neuropathy, hematuria, spinal
cord compression, or urethral or bladder outlet obstruction. Patients with metastatic
vertebral lesions and/or urinary tract obstruction should be closely observed.
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)
