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IMPORTANT SAFETY INFORMATION | PRESCRIBING INFORMATION
For ADT patients with advanced prostate cancer…
EVALUATE EFFECTIVE T SUPPRESSION* IN YOUR PATIENTS’ GnRH THERAPY
Measure
"Measuring testosterone levels helps to assess if biochemical castration has been achieved and maintained."
– Crawford 20181
Many men experience testosterone breakthroughs while on ADT therapy.2‑7
Testosterone breakthroughs produce PSA increases, mimicking progression to CRPC.2‑8
With rising PSA it is critical to ensure that T is below castration levels to prevent an erroneous diagnosis of castration resistance.9
Neglecting to assess testosterone will fail to identify levels above the desired target throughout the dosing period, including microsurges, and escapes.1
T levels should be monitored frequently in men receiving ADT to ensure T suppression is being maintained to target.**1
Adding a testosterone test to regular PSA assessment is simple to implement and can help address these concerns.1
ACT
Consider TRELSTAR® for proven testosterone suppression in patients with advanced prostate cancer.*
 
TRELSTAR lowered and maintained testosterone below castration levels.*†10
See Efficacy and Study Designs Below
Fewer testosterone breakthroughs than Lupron® in a head-to-head study.†11
  • 4 TRELSTAR escapes occurred within the first 2 months of therapy only
  • 11 leuprolide acetate escapes occurred throughout the entire 9-month study period
See Efficacy and Study Designs Below
Testosterone and PSA suppression regardless of strength.*†§¶11
  • >96% reduction in PSA level from baseline to end of study
See Efficacy and Study Designs Below

*Primary Endpoint Results:
Castration levels of serum testosterone (≤ 1.735 nmol/L; equivalent to 50 ng/dL) in patients treated with TRELSTAR 3.75 mg were achieved at Day 29 in 125 of 137 (91.2%) patients and at Day 57 in 97.7% of patients. Maintenance of castration levels of serum testosterone from Day 57 through Day 253 was found in 96.2% of patients treated with TRELSTAR 3.75 mg.

DOSING SCHEDULES YOU CAN COUNT ON TO MAINTAIN LOW T*

TRELSTAR is available in 3 convenient dosage strengths with distinct dosing schedules to meet the individual needs of your patients.‡10

EVERY 4 WEEKS
TRELSTAR 3.75 mg
Efficacy TRELSTAR 3.75 mg: castration achieved at Day 29 in 125 of 137 (91.2%) patients and at Day 57 in 97.7% of patients. Castration maintained in 96.2% of patients from Day 57 through Day 253.
EVERY 12 WEEKS
TRELSTAR 11.25 mg
Efficacy TRELSTAR 11.25 mg: castration achieved at Day 29 in 167 of 171 (97.7%) patients. Castration maintained in 94.4% of patients from Day 57 through Day 253.§
EVERY 24 WEEKS
TRELSTAR 22.5 mg
Efficacy TRELSTAR 22.5 mg: castration achieved at Day 29 in 97.5% (117 of 120) of patients. Castration maintained in 93.3% of patients from Day 57 to Day 337.

Study Designs

3.75 mg: Based on a 9-month, multicenter, parallel-group, double-blind, randomized, controlled clinical trial comparing TRELSTAR 3.75 mg to leuprolide acetate (7.5 mg) in patients with advanced (stage C/D) prostate cancer (N = 284). Mean testosterone levels were calculated for Months 2 to 9. The primary efficacy endpoints were both achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253.10,12

§11.25 mg: In a study of similar design, patients received either TRELSTAR 11.25 mg (N = 174) every 12 weeks for a total of up to 3 doses (maximum treatment period of 253 days) or TRELSTAR 3.75 mg (N = 172) every 28 days for a total of up to 9 doses. The primary efficacy endpoints were both achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253.10

22.5 mg: In a non-comparative trial, patients received TRELSTAR 22.5 mg (N = 120) every 24 weeks for a total of 2 doses (maximum treatment period of 337 days). The primary efficacy endpoints included achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 337.10

*50 ng/dL
Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule.

ADT = androgen deprivation therapy; CRPC = castrate-resistant prostate cancer; GnRH = Gonadotropin-releasing hormone; PSA = prostate-specific antigen; T = testosterone

References +- 

  1. Crawford ED, Heidenreich A, Lawrentschuk N, et al. Androgen-targeted therapy in men with prostate cancer: Evolving practice and future considerations. Prostate Cancer Prostatic Dis. 2018;22:24‑38.
  2. Bertaglia V, Tucci M, Fiori C, et al. Effects of serum testosterone levels after 6 months of androgen deprivation therapy on the outcome of patients with prostate cancer. Clin Genitourin Cancer. 2013;11:325‑30.
  3. Dason S, Allard CB, Tong J, et al. Defining a new testosterone threshold for medical castration: Results from a prospective cohort series. Can Urol Assoc J. 2013;7:E263‑7.
  4. Kawakami J, Morales A. Clinical significance of suboptimal hormonal levels in men with prostate cancer treated with LHRH agonists. Can Urol Assoc J. 2013;7:E226‑30.
  5. Klotz L, O’Callaghan C, Ding K, et al. Nadir testosterone within first year of androgen deprivation therapy (ADT) predicts for time to castration-resistant progression: A secondary analysis of the PR-7 trial of intermittent vs. continuous ADT. J Clin Oncol. 2015;33:1151‑6.
  6. Morote J, Orsola A, Planas J, et al. Redefining clinically significant castrate levels in patients with prostate cancer receiving continuous androgen deprivation therapy. J Urol. 2007;178:1290‑95.
  7. Van der Sluis TM, Bui HN, Meuleman EJH, et al. Lower testosterone levels with luteinizing hormone-releasing hormone agonist therapy than with surgical castration: New insights attained by mass spectrometry. J Urol. 2012;187:1601‑7.
  8. Wang Y, Dai B, Ye DW. Serum testosterone level predicts the effective time of androgen deprivation therapy in metastatic prostate cancer patients. Asian J Androl. 2017;19:178‑183.
  9. Crawford ED, Twardowski PW, Concepcion RS, et al. The impact of late luteinizing hormone releasing hormone agonist dosing on testosterone suppression in patients with prostate cancer: An analysis of United States clinical data. J Urol. 2020;203:743‑50.
  10. TRELSTAR® (triptorelin pamoate for injectable suspension) [prescribing information]. Ewing, NJ: Verity Pharmaceuticals, Inc. April 2024.
  11. Data on file, Verity Pharmaceuticals, Inc.
  12. 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.

TSR-114 June 2024

TRELSTAR can be ordered directly from our national specialty distributors which provide next business day delivery and other convenient benefits.

Order from AndaMEDS®

Call AndaMEDS at 1.855.468.5649, ext.74453.
Login using your existing TRELSTAR account with AndaMEDS®, or register for a new account, at www.andameds.com.

Order from Besse Medical

Call Besse Medical at 800.543.2111.
Login using your existing TRELSTAR account with with Besse Medical, or register for a new account, at www.besse.com.

Order from CuraScriptSD®

Call CuraScriptSD® at 877.599.7748.
Login using your existing TRELSTAR account with CuraScriptSD® , or register for a new account, at www.curascriptsd.com.

 

Order from Apexus®

For 340B entities order through the prime vendor, Apexus at www.apexus.com.

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