For a six‑month course of leuprolide 11.25 mg depot, how many vials are needed and what is the dosing schedule?

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Leuprolide 11.25mg Depot: Vial Requirements and Dosing Schedule

For a six-month course of leuprolide 11.25 mg depot, you need 2 vials administered as one injection every 3 months (at baseline and at 3 months).

Dosing Schedule

  • Initial dose: Leuprolide acetate 11.25 mg IM at Day 0 1
  • Second dose: Leuprolide acetate 11.25 mg IM at Month 3 1, 2
  • Total duration: 6 months of continuous hormonal suppression 1

Pharmacokinetic Profile

The 11.25 mg three-month depot formulation provides sustained drug release through biodegradable polylactic acid (PLA) microspheres 1:

  • Peak concentration (Cmax): Approximately 20 mcg/L occurs within 3 hours after subcutaneous or intramuscular injection 1
  • Steady-state levels: Maintains continuous drug concentrations of 0.43 to 0.19 mcg/L from day 7 until the next injection at 3 months 1
  • Duration of action: Ensures therapeutic suppression for the full 3-month interval between doses 1

Clinical Applications

This formulation is FDA-approved and clinically validated for:

  • Central precocious puberty: The 11.25 mg dose every 3 months effectively suppresses the GnRH axis with 78.4% achieving peak-stimulated LH suppression 2
  • Prostate cancer: Used for androgen deprivation therapy in advanced disease 3
  • Endometriosis and uterine fibroids: Standard treatment duration is 6 months (2 injections) due to bone mineral density concerns 4

Administration Considerations

  • Route: Intramuscular (IM) injection is the standard route 5, 1
  • Injection site reactions: More common with 3-month depot formulations compared to monthly formulations, but generally well tolerated 1
  • Monitoring: Verify hormonal suppression (testosterone/estradiol levels) at appropriate intervals, particularly in patients under 60 years 5

Important Clinical Caveat

The 11.25 mg formulation should not be confused with the 3.75 mg monthly depot, which would require 6 vials for a 6-month course 3, 4. The three-month formulation specifically reduces injection frequency from 12 injections per year to 4 injections per year, improving patient compliance 6.

References

1
Research

Clinical pharmacokinetics of depot leuprorelin.

Clinical pharmacokinetics, 2002

3
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

5
Guideline

Leuprolide Acetate Formulations

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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