Trelstar® Frequently Asked Questions (FAQS)
Trelstar is indicated for the palliative treatment of advanced prostate cancer.
Questions About Efficacy
Questions About Administration
Questions About Support Services
Questions About Safety
Questions About Efficacy
Clinical trials have demonstrated that Trelstar achieves and maintains serum testosterone levels similar to those achieved with surgical castration.1 Initially, Trelstar causes a transient increase in serum testosterone levels.1 After chronic and continuous administration—usually 2 to 4 weeks after initiation of therapy—a sustained decrease in LH and FSH secretion and marked reduction of testicular steroidogenesis are observed. A reduction of serum testosterone concentration to a level typically seen in surgically castrated men is obtained.1 In clinical trials, >93% of all patients maintained castrate levels from month 2 through the end of the trial.1
Click on the links below for more information on each Trelstar formulation:
Clinical studies with Trelstar have demonstrated a durable reduction in prostate specific antigen (PSA) levels. Specifically, PSA levels were reduced by 96% through month 12 during treatment with 6-month Trelstar 22.5 mg and by 97% through month 9 during treatment with 3-month Trelstar 11.25 mg and 1-month Trelstar 3.75 mg.3-5
Yes, Trelstar has effectively suppressed testosterone production in a multiracial population with advanced prostate cancer. All of the Trelstar phase 3 studies included multiracial populations.
Trelstar Patient Characteristics
| Trelstar 22.5 mg 2 | Trelstar 11.25 mg 4 | Trelstar 3.75 mg 5 | |
|---|---|---|---|
| Caucasian | 64% | 48% | 59.9% |
| Black | 23% | 38% | 39.3% |
| Other | 13% | 15% | 0.8% |
Patients in the Trelstar clinical studies had advanced prostate cancer. Patients included in the Trelstar clinical trials were those with T3-4NxMx or TxN1-3Mx or TxNxM1 according to the TNM classification system.2,4,5
Triptorelin has been in clinical use for over 20 years worldwide. In addition, it is now registered for use in more than 80 countries.2
Questions About Administration
Trelstar is administered by intramuscular injection. Trelstar can be administered using the MIXJECT® single-dose delivery system or manually reconstituted using a syringe fitted with a sterile 21-gauge needle. Please see the Administering Trelstar section of this website for more details.
A low incidence of injection site pain has been reported in Trelstar clinical trials:
- 6-month Trelstar 22.5 mg—1.7%2
- 3-month Trelstar 11.25 mg—4.0%1
- 1-month Trelstar 3.75 mg—3.6%1
The MIXJECT® system is an all-inclusive sterilized kit that does not require refrigeration (store at 68°-77°F), simplifies drug administration (no needle required for reconstitution, 21-gauge needle), and shields the needle until drug administration to protect staff and patients. Following administration, the MIXJECT® needle is captured to help comply with OSHA regulations.
The dosing schedule depends on the product strength selected.1
- Trelstar 22.5 mg—one injection every 6 months (24 weeks)1
- Trelstar 11.25 mg—one injection every 3 months (12 weeks)1
- Trelstar 3.75 mg—one injection every month (4 weeks)1
Questions About Support Services
Trelstar is complemented by a full range of support services, including a preferred distributor, reimbursement assistance, patient education, and an Indigent Patient Program.
J3315
Comprehensive ordering and reimbursement services are offered through the Trelstar Support Line:
866-75-J3315
Order Trelstar (directly from our preferred distributor, Intellogics, at 866-75-J3315 (option 1) during the hours of 8:30 am to 7:00 pm EST. If you already have an account with Intellogics you may also order Trelstar online at www.intellogics.com/login.aspx.
Reimbursement counselors are available from 9:00 AM to 8:00 PM EST at 866-75-J3315 (option 2) to help you with the following services:
Insurance coverage verification
- Contacting insurers to determine each patient’s insurance coverage, copayment obligations, and availability of benefits
- Providing information and general assistance regarding insurers’ pre-certification and prior authorization procedures
Coding and coverage
- Confirming proper coding to use on claim forms
- Providing guidance and updated information regarding payer policies for physicians, reimbursement managers, and other office staff
Claim review and denial assistance
- Reviewing denied claims for accuracy and completeness
- Obtaining appropriate reimbursement by assisting in the denial and appeals process
- Preparing a letter of medical necessity
- Communicating with your office to ensure that appealed claims are reimbursed appropriately
Indigent Patient Program
- Screening patients for eligibility and enrolling indigent patients who need assistance obtaining Trelstar
- Identifying alternate funding sources for patients who are uninsured or underinsured
Questions About Safety
The most common adverse events seen in clinical studies were hot flushes, skeletal pain, impotence/erectile dysfunction, testicular atrophy, headache, and leg pain and edema.
Trelstar may cause an initial temporary surge in testosterone levels, which can worsen symptoms of prostate cancer during the first few weeks of treatment. This worsening of symptoms is referred to as “clinical flare.” Patients may experience worsening of bone pain, neuropathy, blood in the urine, or obstruction of the bladder and/or urethra. These symptoms may disappear with continued therapy.
Indication
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.
