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– Heyns et al, 2003
†At day 253, n=119 for Trelstar and n=121 for Lupron®.
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 Lupron®.
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.
Trelstar 3.75 mg†
Trelstar 11.25 mg†
Trelstar 22.5 mg†
Trelstar 3.75 mg†
Trelstar 11.25 mg†
Trelstar 22.5 mg†
*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.
INDICATIONS AND USAGE
TRELSTAR® (triptorelin pamoate for injectable suspension) is a gonadotropin-releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Hypersensitivity: TRELSTAR® is contraindicated in individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Anaphylactic shock, hypersensitivity, and angioedema related to triptorelin administration have been reported. In the event of a reaction, discontinue TRELSTAR immediately and administer the appropriate supportive and symptomatic care.
Transient Increase in Serum Testosterone: Transient increase in serum testosterone levels can occur within the first few weeks of treatment. Worsening of signs and symptoms of prostate cancer or onset of new symptoms have been reported including bone pain, neuropathy, hematuria, or urethral or bladder outlet obstruction. Monitor patients at risk and manage as appropriate.
Metastatic Vertebral Lesions and Urinary Tract Obstruction: Cases of spinal cord compression, which may contribute to weakness or paralysis with or without fatal complications, have been reported with GnRH agonists. If spinal cord compression or renal impairment develops, standard treatment should be instituted, and in extreme cases an immediate orchiectomy considered. Closely observe patients with metastatic vertebral lesions and/or with upper or lower urinary tract obstruction during the first few weeks of therapy.
Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and in patients taking drugs known to prolong the QT interval. Electrolyte abnormalities should be corrected. Consider periodic monitoring of electrocardiograms and electrolytes.
Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes.
Cardiovascular Diseases: Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Monitor for symptoms and signs suggestive of development of cardiovascular disease and be managed according to current clinical practice.
Laboratory Tests: Response to TRELSTAR® should be monitored by measuring serum levels of testosterone periodically or as indicated.
Laboratory Test Interactions: Chronic or continuous administration of triptorelin in therapeutic doses results in suppression of pituitary-gonadal axis. Diagnostic tests of the pituitary-gonadal function conducted during treatment and after cessation of therapy may therefore be misleading.
Embryo-Fetal Toxicity: TRELSTAR® can cause fetal harm when administered to a pregnant woman. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
MOST COMMON ADVERSE REACTIONS
• TRELSTAR 3.75 mg: Most common adverse reactions (≥ 5%) included hot flushes, skeletal pain, impotence, and headache.
• TRELSTAR 11.25 mg: Most common adverse reactions (≥ 5%) included hot flushes, skeletal pain, headache, edema in the legs, and leg pain.
• TRELSTAR 22.5 mg: Most common adverse reactions (≥ 5%) included hot flushes, erectile dysfunction, and testicular atrophy.
SPECIFIC POPULATIONS
Pregnancy: TRELSTAR® can cause fetal harm when administered to a pregnant woman. Expected hormonal changes that occur with TRELSTAR® treatment increase the risk for pregnancy loss. Advise pregnant patients and females of reproductive potential of the potential risk to the fetus.
Lactation: The safety and efficacy of TRELSTAR® have not been established in females. Because of the potential for serious adverse reactions in a breastfed child from TRELSTAR®, a decision should be made to either discontinue breastfeeding, or discontinue the drug taking into account the importance of the drug to the mother.
Females and Males of Reproductive Potential: TRELSTAR® may impair fertility.
Renal/Hepatic Impairment: Subjects with renal or hepatic impairment had higher exposure than young healthy males.
To report SUSPECTED ADVERSE REACTIONS, contact Verity Pharma at 1-844-837-4891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For more information, visit www.Trelstar.com, or call 1-844-837-4891.
Please see the accompanying full Prescribing Information.
Trelstar® and its design are registered trademarks licensed to Verity Pharmaceuticals Inc.
Verity Pharmaceuticals™ and its designs are trademarks of Verity Pharmaceuticals Inc.
MIXJECT® is a registered trademark of West Pharmaceutical Services IL, Ltd.
All other trademarks are the property of their respective owners.
© 2021 Verity Pharmaceuticals Inc. All rights reserved.
TSR-021 November 2021
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 the 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.
The 3.75 mg data are based on a 9-month, multicenter, parallel-group, blindly randomized, controlled clinical trial comparing Trelstar® 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.
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