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| TRELSTAR is a luteinizing hormone releasing hormone (LHRH) agonist and is indicated in the palliative treatment of advanced prostate cancer. It offers an alternative treatment for prostate cancer when orchiectomy or estrogen administration are either not indicated or unacceptable to the patient.
TRELSTAR reduces serum testosterone concentrations to below castrate levels within 1 month of therapy and maintains serum testosterone concentrations below castrate levels during continued therapy.
TRELSTAR is available in a 4 week depot formulation, TRELSTAR Depot, and a 12 week long acting formulation, TRELSTAR LA. |
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| TRELSTAR DEPOT is a sterile, lyophilized biodegradable microgranule formulation supplied as a single-dose vial containing triptorelin pamoate (3.75 mg as the peptide base), 170 mg poly-d, l-lactide-co-glycolide, 85 mg mannitol, USP, 30 mg carboxymethylcellulose sodium, USP, 2 mg polysorbate 80, NF. When 2 mL sterile water for injection is added to the vial containing TRELSTAR DEPOT and mixed, a suspension is formed which is intended as a monthly intramuscular injection. |
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| TRELSTAR LA is a sterile, lyophilized biodegradable microgranule formulation supplied as a single-dose vial containing triptorelin pamoate (11.25 mg as the peptide base), 145 mg poly-d, l-lactide-coglycolide, 85 mg mannitol, USP, 30 mg carboxymethylcellulose sodium, USP, 2 mg polysorbate 80, NF. When 2 mL sterile water for injection is added to the vial containing TRELSTAR LA and mixed, a suspension is formed which is intended as an intramuscular injection to be administered every 84 days (ie, every 12 weeks). |
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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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