Trelstar LA
Company: Debiopharm
Approval Status: Approved June 2001
Treatment for: Prostate cancer
Areas: Endocrinology; Nephrology/Urology; Oncology
Possible similar drugs: Trelstar Depot
| General Information | Clinical Results | Side Effects | Mechanism of Action | Additional Information |
General Information
Trelstar LA, a three month controlled release formulation of triptorelin pamoate, has been approved for the treatment of advanced stage prostate cancer. A one month controlled release formulation, Trelstar Depot, was approved in June 2000.
Trelstar LA is approved both as a vial of triptorelin pamoate to be reconstituted in sterile water for injection, and as the DebioClip single dose delivery system that consists of a vial of triptorelin pamoate and a pre-filled syringe of sterile water for injection.
Prostate cancer is second only to skin cancer in being the most common cancer found in American men. The American Cancer Society predicts there will be close to 200,000 new cases of prostate cancer diagnosed in the United States in 2001.
Clinical Results
In a pivotal clinical trial, Trelstar LA was shown to be as effective as the previously approved Trelstar Depot. Additional study objectives included regression of pain, mean change in the Quality of Life scale during treatment, and testosterone pharmacodynamics. Subjects who received triptorelin pamoate used fewer analgesics after beginning treatment and overall gained an average of five kg in body weight.
Side Effects
Adverse events associated with the use of Trelstar LA may include (but are not limited to) the following:
- Fatigue
- Nausea
- Vomiting
- Diarrhea
- Decreased blood cell counts
- Hair loss
- Mouth sores
- Hot flashes
- Loss of sexual drive
- Breast tenderness
Warning - triptorelin pamoate should not be taken while pregnant
Mechanism of Action
Triptorelin pamoate is a potent repressor of gonadotropin secretion when given continuously and in therapeutic doses. Following initial administration, there is a transient surge in circulating levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone, and estradiol. After chronic and continuous administration, usually two to four weeks after beginning therapy, a sustained decrease in LH and FSH secretion and marked reduction of testicular and ovarian steroidogenesis is observed. In men, a reduction in serum testosterone concentration to a level typically seen in surgically castrated men is obtained. Consequently, tissues and functions that depend on these hormones for maintenance become quiescent. These effects are usually reversible after cessation of therapy.
Additional Information
For additional information on prostate cancer, please visit the American Cancer Society.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
