Monitoring Your Patients
Response should be monitored with a GnRHa stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1–3 months after initiation of therapy and at Month 6.2
- Response should be monitored further as judged clinically appropriate to verify adequate suppression2
Height (for calculation of growth rate) and bone age should be assessed every 6-12 months.2
LUPRON DEPOT-PED for 1-month Administration2
LUPRON DEPOT-PED is administered as a single intramuscular injection once a month. The starting dose is determined by the child’s weight.
Dosing Recommendations Based on Body Weight for LUPRON DEPOT-PED 1-Month Formulations
|Body Weight||Recommended Dose|
|≤ 25 kg||7.5 mg|
|> 25-37.5 kg||11.25 mg|
|> 37.5 kg||15 mg|
The dose of LUPRON DEPOT-PED must be individualized for each child. If adequate hormonal and clinical suppression is not achieved with the starting dose, it should be increased to the next available higher dose.
The dose may also be adjusted with changes in body weight.
The injection site should be varied periodically.
LUPRON DEPOT-PED should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.
LUPRON DEPOT-PED Syringe
- Fine 23-gauge 1.5" needle on all LUPRON DEPOT-PED doses2,4
- LuproLoc® safety device2
- OSHA-compliant mechanism helps prevent needlestick injuries5
- Prefilled dual-chamber syringe2
- No external mixing of ingredients is required
Microsphere Technology of LUPRON DEPOT Formulations Used in
1- and 3-Month Dosing2
- The active drug, leuprolide, is embedded in microcapsules composed of biodegradable, hydrophobic polymers to overcome high solubility in body fluids and rapid excretion in vivo6
- 1-month depot: Lactic acid-glycolic acid copolymer (PLGA)2
- 3-month depot: Polylactic acid (PLA)2
- Leuprolide is released in two phases in vivo
- Diffusion phase: from near the surface of a swollen microsphere immediately after injection6
- Bioerosion phase: during erosion of the biodegradable polymer5
LUPRON DEPOT Mechanism of Drug Release6
Pharmacokinetics of LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-Month Administration2
Following a single administration of LUPRON DEPOT-PED 3-month 11.25 mg or 30 mg to children with CPP, leuprolide concentrations increased with increasing dose.2
Mean Peak Leuprolide Plasma Concentrations Following a Single Dose2
|Dose Level||At 1 hour (ng/mL)||At 2 Weeks (ng/mL)|
|11.25 mg||19.1 ng/mL||0.08 ng/mL|
|30 mg||52.5 ng/mL||0.25 ng/mL|
- Mean leuprolide plasma concentration remained constant from Month 1 to Month 3 for both the 11.25- and 30-mg doses2
- The mean leuprolide concentrations for 3 months after the first and second injections were similar, indicating no accumulation of leuprolide from repeated administration2
References: 1.IMS Health, IMS National Prescription Audit, June 2016. 2. LUPRON DEPOT-PED [package insert]. North Chicago, IL: AbbVie Inc. May 2017 Printed in U.S.A. 3. Lee PA, Neely EK, Fuqua J, et al. Efficacy of leuprolide acetate 1-month depot for central precocious puberty (CPP): growth outcomes during a prospective, longitudinal study. Int J Pediatr Endocrinol. 2011; 2011(1):7. doi:10.1186/1687-9856-2011-7. Epub 2011 Jul 12. 4. Data on File AbbVie, Inc. ABVRRT163124. 5. United States Department of Labor. Occupational Safety & Health Administration §1910.1030 Bloodborne Pathogens. Available at: https://www.osha.gov/needlesticks/needlesticks-regtxtrev.html. Accessed June 23, 2016. 6. Okada H. One- and three-month release injectable microspheres of the LH-RH superagonist leuprorelin acetate. Adv Drug Deliv Rev. 1998;28(1):43-70.