Dosing & Administration

LUPRON DEPOT-PED is the #1 prescribed GnRHa for CPP in the US 1

Monthly LUPRON DEPOT-PED is the CPP treatment with 18 years of long-term clinical trial data in its Prescribing Information.2,3

LUPRON DEPOT-PED offers multiple dosing options to help you fit your patient’s schedule (1- or 3-month)2

1-month

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7.5 mg

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11.25 mg

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15 mg

3-month

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11.25 mg

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30 mg

Prescribe 3-month 30-mg Dosing
NDC 0074-9694-03

3-month dosing lets you monitor patients and administer treatment together at quarterly visits, as well as make timely adjustments to dosing

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

 

Dosing

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 for 3-month Administration

LUPRON DEPOT-PED should be administered once every 3 months (12 weeks) as a single intramuscular injection.2

LUPRON DEPOT-PED should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.2

LUPRON DEPOT-PED Syringe

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Key Features

  1. Fine 23-gauge 1.5" needle on all LUPRON DEPOT-PED doses2,4
  2. LuproLoc® safety device2
    • OSHA-compliant mechanism helps prevent needlestick injuries5
  3. Prefilled dual-chamber syringe2
    • No external mixing of ingredients is required
  • Dosing volumes2
    • 1-month: 1 mL
    • 3-month: 1.5 mL
  • No refrigeration required2

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

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Visual interpretation of micosphere drug release.6

 

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.