Leuprolide 20 Unit Dose: Appropriate Indication
A 20 unit dose (1 mg) of leuprolide is appropriate for the treatment of central precocious puberty in children, administered as a single daily subcutaneous injection. 1
FDA-Approved Dosing for Central Precocious Puberty
The FDA label explicitly states that the recommended dose for central precocious puberty is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. 1 This formulation contains 1 mg of leuprolide acetate per 0.2 mL, with the injection site varied periodically to minimize local reactions. 1
Clinical Evidence Supporting This Indication
Mechanism and Efficacy in Precocious Puberty
Leuprolide acts as a GnRH agonist that initially stimulates gonadotropin release, followed by pituitary desensitization and down-regulation, leading to suppressed circulating levels of gonadotrophins and sex hormones. 2
In children with central precocious puberty, leuprolide decreases mean growth velocity, reduces signs of sexual maturation, and increases predicted adult height compared with baseline measurements. 2
Clinical trials demonstrate effective suppression of estradiol and gonadotropin secretion with daily subcutaneous administration, making it a first-line therapy for this rare disease in the absence of effective alternatives. 2, 3
Dosing Considerations for Precocious Puberty
The 1 mg daily subcutaneous dose is distinct from the depot formulations used for other indications. 1
Depot formulations (3.75 mg IM every 28 days for children ≥20 kg, or 1.87 mg for children <20 kg) are also used for central precocious puberty but represent a different dosing strategy than the 20 unit daily injection. 4, 5
Monitoring is essential: GnRH stimulation testing should be repeated at least at 6-month intervals, as some patients require dosage adjustments 5-10 months after initial suppression. 5
Important Clinical Caveats
Not for Other Indications at This Dose
For ovarian function suppression in breast cancer, NCCN guidelines recommend leuprolide 3.75–7.5 mg IM every 4 weeks or 11.25–22.5 mg IM every 12 weeks—not the 1 mg daily dose. 6
For endometriosis and uterine fibroids, depot leuprolide 3.75 mg monthly is the standard regimen, not daily 1 mg injections. 2, 6
For prostate cancer, depot injections of 3.75 or 7.5 mg monthly are used, not the daily subcutaneous formulation. 2
Administration Technique
Inspect the solution for discoloration and particulate matter before each use. 1
Rotate injection sites periodically to prevent local reactions, as cutaneous reactions can be associated with incomplete suppression and may require treatment interruption. 1, 4