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TRELSTAR is an LHRH agonist indicated in the palliative treatment of advanced prostate
cancer.
In clinical trials, TRELSTAR produced a transient surge in testosterone levels [1,2] that peaked on days 2–3 with TRELSTAR LA and on day 4 with TRELSTAR Depot. TRELSTAR LA and Depot reduced serum testosterone concentrations below castrate levels [1,2]. In addition, >94% of all patients maintained castrate levels from month 2 through month 9.
Clinical studies with TRELSTAR have demonstrated a durable reduction in prostate-specific antigen (PSA) levels. Specifically, PSA levels were reduced by 97% through month 9 [3,4]
Yes, TRELSTAR has effectively suppressed testosterone production in a multiracial population with advanced prostate cancer.
Patients in the TRELSTAR clinical studies had stage C/D disease [3,4]
Triptorelin, in all formulations, has been in clinical use for about 20 years worldwide. In addition, there has been long-term use of triptorelin in all formulations, in more than 80 countries worldwide. [5]
TRELSTAR is administered by intramuscular injection. TRELSTAR can be administered using the Clip’n’Ject single-dose delivery system or manually reconstituted using a syringe fitted with a sterile 20-gauge needle. Please see full prescribing information for more details.
In clinical studies, pain (≤4.0%) was the only reported injection site reaction occurring in ≥1% of patients. [1,2]
The Clip’n’Ject System is an all-inclusive sterilized kit that does not require refrigeration (store at 68°-77°F), simplifies drug administration, and shields the needle until drug administration to protect staff and patients.
The recommended dose of TRELSTAR LA is 11.25 mg incorporated in a long acting formulation administered every 84 days as a single intramuscular injection administered in either buttock.
The recommended dose of TRELSTAR Depot is 3.75 mg incorporated in a depot formulation and is administered monthly as a single intramuscular injection.
TRELSTAR is complemented by a full range of support services, including a preferred distributor, reimbursement assistance, patient education, and an Indigent Patient Program.
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Comprehensive ordering and reimbursement is offered through the TRELSTAR Support Line:
866-755-3315
Click here for information on how to order TRELSTAR.
Reimbursement counselors are available from 9:00 AM to 8:00 PM EST at
866-755-3315 (option 2) to help you with the following services:
Insurance coverage verification
- Contacting insurers to determine each patient’s insurance coverage, co-payment 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.
The most common adverse events seen in clinical studies were hot flushes, skeletal pain, impotence, headache, and leg pain and swelling.
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. Although not indicated for use with TRELSTAR, antiandrogens, such as flutamide or bicalutamide, are commonly administered with LHRH agonists to reduce clinical flare in advanced prostate cancer patients.
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References: 1. TRELSTAR Depot full Prescribing Information, Watson Pharma, Inc. 2. TRELSTAR LA full Prescribing Information, Watson Pharma, Inc. 3. Clinical Study Report DEB-96-TRI-01 (first phase). Data on file, Watson Laboratories, Inc. 4. Clinical Study Report DEB-96-TRI-01 (second phase). Data on file, Watson Laboratories, Inc. 5. Data on file, Watson Pharma, Inc. |
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