Leuprolide acetate for depot suspension

(Lupron®)

Lupron®

Drug updated on 5/17/2024

Dosage FormInjection (intramuscular; 7.5 mg, 22.5 mg, 30 mg, and 45 mg)
Drug ClassGonadotropin-releasing hormone agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of advanced prostate cancer.

Summary
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  • Leuprolide acetate for depot suspension (Lupron) is indicated for the treatment of advanced prostate cancer. It belongs to the gonadotropin-releasing hormone (GnRH) class, and its safety and effectiveness have been compared with other drugs in this class, specifically GnRH agonists and antagonists.
  • The information was derived from two studies that focused on Leuprolide's use in treating advanced prostate cancer.
  • One study reviewed randomized controlled trials comparing cardiovascular safety between GnRH antagonists such as degarelix and relugolix, versus GnRH agonists like leuprolide. This analysis included data from 10 studies involving a total of 3,729 participants. Results showed significantly lower risk ratios for adverse cardiovascular events, cardiovascular death, and all-cause mortality among recipients of GnRH antagonists compared to those treated with GnRH agonists like Lupron.
  • However, limitations were noted including short duration follow-up periods, unblinded study design, and identification of adverse events mainly through safety reporting mechanisms, which necessitate cautious interpretation of these findings.
  • A second study highlighted a rare but significant complication associated with the use of GnRH agonist therapy: pituitary apoplexy. Outcomes suggested that while generally safe overall, there are specific risks associated with patients who have pre-existing pituitary adenoma when using Lupron or similar therapies.
  • Both studies underscored distinct aspects regarding Leuprolide's safety profile within the wider context of treatments available for prostate cancer - suggesting potential benefits offered by GnRH antagonists over GnRH agonists like Lupron, especially concerning cardiovascular outcomes, while also highlighting critical considerations related to pituitary apoplexy, particularly among susceptible individuals with existing pituitary adenomas.

Product Monograph / Prescribing Information

Document TitleYearSource
Lupron Depot (Leuprolide Acetate For Depot Suspension) Prescribing Information.2024AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses