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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.
†Based on a multicenter, parallel-group, randomized, controlled clinical trial comparing TRELSTAR Depot to leuprolide acetate (active comparator) in patients with advanced (stage C/D) prostate cancer (n=284). Investigators and patients were blinded to the treatment assignment at time of enrollment.
- During treatment with TRELSTAR Depot, mean testosterone concentrations were
maintained below 50 ng/dL in 98.8% of patients and below 20 ng/dL in 96% of patients
in months 2 through 9 [1]
- During treatment with TRELSTAR LA, 96% and 92% of patients maintained mean
testosterone concentrations below 50 ng/dL and 20 ng/dL, respectively, in months
2 through 9 [2]
- TRELSTAR suppressed mean testosterone concentrations between months 2 and 9
- Mean levels did not exceed 8.1 ng/dL in TRELSTAR Depot-treated patients [1]
- In TRELSTAR LA-treated patients, mean levels did not exceed 12.4 ng/dL [2]
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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 or 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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)
