What Is Trelstar?
Trelstar is a gonadotropin releasing hormone (GnRH) agonist that is indicated in the palliative treatment of advanced prostate cancer.1 Trelstar reduces serum testosterone concentrations to below castrate level within 1 month of therapy and maintains serum testosterone concentrations below castrate level during continued therapy.1
Trelstar is available in three formulations for administration by intramuscular injection:1
- Trelstar 22.5 mg administered every 6 months (24 weeks)
- Trelstar 11.25 mg administered every 3 months (12 weeks)
- Trelstar 3.75 mg administered once a month (4 weeks)
Trelstar is a white to slightly yellow lyophilized cake. When reconstituted, Trelstar has a milky appearance.1 It contains a pamoate salt of triptorelin, a synthetic decapeptide agonist analog of GnRH.1 The Trelstar products are sterile, lyophilized biodegradable microgranule formulations.1 The composition of each Trelstar product is given in the following table:1
|triptorelin pamoate (base units)||3.75 mg||11.25 mg||22.5 mg|
|poly-d,l-lactide-co-glycolide||136 mg||118 mg||182 mg|
|mannitol, USP||69 mg||76 mg||68 mg|
|carboxymethylcellulose sodium, USP||24 mg||27 mg||24 mg|
|polysorbate 80, NF||1.6 mg||1.8 mg||1.6 mg|
When 2 mL sterile water is added to the vial containing Trelstar and mixed, a suspension is formed which is intended as an intramuscular injection.1 Trelstar is available as a vial plus a MIXJECT® vial adapter, and a separate prefilled syringe that contains sterile water for injection, USP, 2 mL, pH 6 to 8.5.1 Trelstar is also available in a vial alone.
- Trelstar® full Prescribing Information, Watson Pharma, Inc.
- Data on file, Watson Pharma, Inc. DEB-TRI6M-301 Clinical Study Report, May 2008.
- Lundström EA, Rencken RK, van Wyk JH, et al. Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study. Clin Drug Investig. 2009;29:757-765.
- Data on file. Watson Pharma, Inc. DEB-96-TRI-01 (first phase) Clinical Study Report; July 1999.
- Data on file. Watson Pharma, Inc. DEB-96-TRI-01 (second phase) Clinical Study Report; June 1999.
- Oefelein MG, Feng A, Scolieri MJ, Ricchiutti D, Resnick MI. Reassessment of the definition of castrate levels of testosterone: implications for clinical decision making. Urology. 2000;56:1021-1024.
- Morote J, Orsola A, Planas J, et al. Redefining clinically significant castration levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007;178:1290-1295.
- Heyns CF, Simonin M-P, Grosgurin P, Schall R, Porchet HC. Comparative efficacy of triptorelin pamoate and leuprolide acetate in men with advanced prostate cancer. BJU International. 2003;92:226-231.
Trelstar® is indicated for the palliative treatment of advanced prostate cancer.
Important Safety Information
The most commonly reported adverse events associated with the use of Trelstar® 22.5 mg included hot flushes (71.7%), erectile dysfunction (10.0%), and testicular atrophy (7.5%) • The most commonly reported adverse events associated with the use of Trelstar® 3.75 mg/Trelstar® 11.25 mg 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 GnRH agonists, or GnRH • Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported • Trelstar® 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, urethral or bladder outlet obstruction, or spinal cord compression that may contribute to weakness or paralysis with or without fatal complications. Patients with metastatic vertebral lesions and/or urinary tract obstruction should be closely observed. Hyperglycemia and an increased risk of developing diabetes, as well as increased risk of myocardial infarction, sudden cardiac death, and stroke have been reported in men receiving GnRH analogs. Patients should be monitored for blood glucose level and cardiovascular disease, and managed according to current clinical practice
MIXJECT® is a registered trademark of Medimop Medical Projects Ltd.