From the FDA Drug Label
The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. The dosing regimen for Eligard (leuprolide) in the treatment of prostate cancer is 1 mg administered subcutaneously daily.
- The injection site should be varied periodically. 1
From the Research
Eligard (leuprolide acetate) for prostate cancer is typically administered as a depot injection in doses of 7.5 mg monthly, 22.5 mg every 3 months, 30 mg every 4 months, or 45 mg every 6 months, with the most recent and highest quality study 2 supporting the use of 22.5 mg every 3 months.
Dosing Regimen
The dosing regimen for Eligard (leuprolide acetate) in the treatment of prostate cancer involves administering the medication as a depot injection. The recommended doses are:
- 7.5 mg monthly
- 22.5 mg every 3 months
- 30 mg every 4 months
- 45 mg every 6 months Treatment usually begins with the monthly injection to ensure tolerability before transitioning to longer-acting formulations.
Administration and Monitoring
The medication should be administered subcutaneously by a healthcare professional after proper reconstitution according to the manufacturer's instructions. Patients may experience an initial testosterone surge ("flare") in the first weeks of treatment, which can temporarily worsen symptoms; this can be managed with antiandrogens like bicalutamide for the first few weeks of therapy. Eligard works by downregulating pituitary receptors, eventually leading to decreased luteinizing hormone production and testosterone suppression to castration levels (below 50 ng/dL). Common side effects include hot flashes, fatigue, decreased libido, and potential bone density loss with long-term use. Regular monitoring of PSA levels and testosterone levels is recommended to ensure adequate response to therapy, as supported by studies such as 3 and 2.
Efficacy and Safety
The efficacy and safety of Eligard have been established in several studies, including a Phase 4 study 2 that demonstrated the safety profile of Eligard in Asian men with hormone-dependent prostate cancer is comparable to previous studies in Western regions. Another study 4 compared the efficacy and safety of relugolix, an oral gonadotropin-releasing hormone antagonist, to leuprolide acetate, and found that relugolix was superior in rapidly reducing testosterone and continuously suppressing testosterone, with faster post-treatment recovery of testosterone levels. However, the most recent and highest quality study 2 supports the use of Eligard in the treatment of prostate cancer.
Key Points
- Eligard is administered as a depot injection in various doses
- Treatment usually begins with the monthly injection to ensure tolerability
- Patients may experience an initial testosterone surge ("flare") in the first weeks of treatment
- Common side effects include hot flashes, fatigue, decreased libido, and potential bone density loss with long-term use
- Regular monitoring of PSA levels and testosterone levels is recommended to ensure adequate response to therapy, as supported by studies such as 3, 2, and 5.