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IMPORTANT SAFETY INFORMATION | PRESCRIBING INFORMATION

TRELSTAR
CAN MINIMIZE AGONIST DEFICIENCY

Proven efficacy with the ability to achieve castration (≤ 50 ng/dL) and maintain T levels below 20 ng/dL.2

T = testosterone

Proven Testosterone Suppression:
TRELSTAR lowered testosterone below castration levels (50 ng/dL).1, 2

  • 4 TRELSTAR escapes occurred within the first 2 months of therapy only
  • 11 leuprolide acetate escapes occurred throughout the entire 9-month study period

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.

Safety
TESTOSTERONE ESCAPES THROUGH MONTH 9​ 2,6

– Heyns et al, 2003

†At day 253, n=119 for TRELSTAR and n=121 for leuprolide acetate.

STUDY DESIGN

Based on a 9-month, multicenter, parallel-group, double-blind, randomized, controlled clinical trial comparing TRELSTAR 3.75 mg to leuprolide acetate in patients with advanced (stage C/D) prostate cancer (N=284). Mean testosterone levels were calculated for months 2 to 9.

[Refs: TRELSTAR PI, Heyns 2003]

 

† At day 253, n=119 for TRELSTAR and n=121 for leuprolide acetate.

Proven Testosterone Suppression (Primary Endpoint)

  • TRELSTAR lowered testosterone below castration levels.*1,2
  • Achieved at Day 29 in 125 of 137 patients (91.2%) with TRELSTAR 3.75 mg.
  • 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.
ALL 3 TRELsTAR FORMULATIONS MAINTAINED CASTRATION LEVELS*

STUDY DESIGN

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 253.1,2

 

 

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 253.1

 

 

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 337.1

 

* (≤ 1.735 nmol/L; equivalent to 50 ng/dL)

† Maintenance of castration was calculated using a frequency distribution.

‡ Cumulative maintenance of castration was calculated using a survival analysis (Kaplan-Meier) technique.

A GnRH THAT CAN
MAINTAIN TESTOSTERONE SUPPRESSION

TRELSTAR can give your patients effective and consistent testosterone suppression.2,6

TRELSTAR ACHIEVED AND MAINTAINED CASTRATE TESTOSTERONE LEVELS ACROSS ALL FORMULATIONS6

Testosterone Reductions

MEAN TESTOSTERONE REDUCTIONS
FROM BASELINE TO END OF STUDY** (%)

TRELSTAR 3.75 mg†

TRELSTAR 11.25 mg†

TRELSTAR 22.5 mg†

PSA Reductions*

MEDIAN PSA REDUCTIONS FROM
BASELINE TO END OF STUDY** (%)

TRELSTAR 3.75 mg†

TRELSTAR 11.25 mg†

TRELSTAR 22.5 mg†

All 3 TRELSTAR formulations effectively suppressed testosterone and prostate-specific antigen (PSA) levels.6

  • Attained mean testosterone levels of <20 ng/dL
  • Maintained mean testosterone levels comparable to surgical castration
    • 8 ng/dL (3.75 mg)
    • 12 ng/dL (11.25 mg)
    • 12 ng/dL (22.5 mg)
  • >96% reduction in PSA level

*Secondary endpoint.

**22.5 mg at Day 337.
†Mean and median baseline levels were measured on Day 1.
‡Percentage reductions reflect weighted means of each formulation.

Study Design

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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Safety

3.75 mg: The most common adverse reactions (≥5%) during TRELSTAR 3.75 mg therapy included hot flushes, skeletal pain, impotence, and headache.

 

11.25 mg: The most common adverse reactions (≥5%) during TRELSTAR 11.25 mg therapy included hot flushes, skeletal pain, headache, edema in legs, and leg pain.

 

22.5 mg: The most common adverse reactions (≥5%) during TRELSTAR 22.5 mg therapy included hot flushes, erectile dysfunction, and testicular atrophy.

Study Design

The 3.75 mg data are based on a 9-month, multicenter, parallel-group, blindly randomized, controlled clinical trial comparing TRELSTAR 3.75 mg to leuprolide acetate in patients with advanced (stage C/D) prostate cancer (N=284). Mean testosterone levels were calculated for months 2 to 9.

 

The 11.25 mg data are based on a 9-month, multicenter, parallel-group, blindly randomized, controlled clinical trial comparing TRELSTAR 11.25 mg to TRELSTAR 3.75 mg (active comparator) in patients with advanced (stage C/D) prostate cancer (N=284). Mean testosterone levels were calculated for months 2 to 9.

 

The 22.5 mg data are based on a 12-month, multicenter, open-label, non-comparative phase 3 clinical trial that evaluated the efficacy, pharmacokinetics, and safety of 2 injections of 6-month TRELSTAR 22.5 mg formulation in patients with advanced prostate cancer. Mean testosterone levels were calculated for months 2 to 12.

Healthcare Professionals

The information contained in this website is intended for US Healthcare professionals only.

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