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FDA approved Trelstar (triptorelin pamoate) for Advanced Prostate CancerFDA approved new drug Trelstar for advanced prostate cancer.

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Key Takeaway
Consider Trelstar as a GnRH agonist option for advanced prostate cancer with flexible dosing every 4, 12, or 24 weeks.

The FDA has approved Trelstar (triptorelin pamoate) for the treatment of advanced prostate cancer. Trelstar is a gonadotropin-releasing hormone (GnRH) agonist that works by suppressing testosterone production. The approval provides clinicians with a flexible dosing option: 3.75 mg every 4 weeks, 11.25 mg every 12 weeks, or 22.5 mg every 24 weeks, administered as a single intramuscular injection. The product is a lyophilized microgranule formulation that must be reconstituted with sterile water and injected within 2 minutes. This approval offers an additional treatment choice for patients with advanced prostate cancer, a condition where androgen deprivation therapy is a cornerstone of management.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Trelstar is a gonadotropin releasing hormone (GnRH) agonist. It suppresses testosterone production in patients with advanced prostate cancer.

Indication & Patient Population

Trelstar is indicated for the treatment of advanced prostate cancer.

Dosing & Administration

Trelstar is administered as a single intramuscular injection in either buttock. The dosage strengths are not additive and must be selected based on the desired dosing schedule: 3.75 mg every 4 weeks, 11.25 mg every 12 weeks, or 22.5 mg every 24 weeks. The lyophilized microgranules are to be reconstituted in sterile water only. The suspension should be administered within 2 minutes after reconstitution. Injection site should be alternated periodically.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Trelstar is a GnRH agonist indicated for the treatment of advanced prostate cancer, providing a flexible dosing schedule for androgen deprivation therapy.

The FDA has approved a new drug called Trelstar (triptorelin pamoate) for the treatment of advanced prostate cancer. This medicine works by lowering the amount of testosterone in the body, which can help slow the growth of cancer cells. It is given as a shot into a muscle, and there are three different dosing schedules: every 4 weeks, every 12 weeks, or every 24 weeks. Your doctor will choose the schedule that is right for you.

Trelstar is for people with advanced prostate cancer, meaning the cancer has spread or is at high risk of spreading. It is a type of hormone therapy, also called androgen deprivation therapy. This approval gives doctors and patients more choices when deciding on treatment.

The approval means that Trelstar is now available as a treatment option. However, it is not a cure for prostate cancer. Like all medicines, it can have side effects. Common side effects may include hot flashes, decreased libido, and injection site reactions.

If you or a loved one has advanced prostate cancer, talk to your doctor about whether Trelstar might be a good option. Your doctor can help you understand the benefits and risks based on your specific health situation.

What this means for you:
Trelstar is a new hormone therapy for advanced prostate cancer that lowers testosterone.

Study Details

Study typeFda approval
PublishedJun 2001
View Original Abstract ↓
1 INDICATIONS AND USAGE TRELSTAR is indicated for the treatment of advanced prostate cancer [ see Clinical Studies (14) ]. TRELSTAR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )
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