6-Month Trelstar® 22.5 mg
Twice-yearly administration allows flexibility
- Fewer office visits for drug administration
- Less frequent preparation of injections
- Fewer units to store
Easy preparation and delivery with MIXJECT
- No refrigeration required
- Simple IM administration
- All inclusive sterilized kit
- No needle required for reconstitution
- Small 21-gauge needle
- Low incidence of injection site pain (1.7%)2
Two injections of 6-month Trelstar 22.5 mg were prospectively studied in a phase 3 trial.1
6-month Trelstar 22.5 mg maintains testosterone levels similar to those achieved with surgical castration.
- Mean testosterone level of 12.8 ng/dL in months 2 through 122
- 97.5% of patients achieved castrate serum testosterone level by day 291
- 98.3% of patients were below castrate level at month 6 and month 122
6-month Trelstar 22.5 mg reliably suppresses prostate specific antigen.
- Median prostate-specific antigen (PSA) levels were reduced by 96.4% through month 122
- 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.