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

 

Multiple Dosing Options

Flexible Dosing Allows You to Tailor Dosing for Each Patient and Coordinate Monitoring Visits with Administration of LUPRON DEPOT-PED

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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3-month

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Prescribe 3-month 30-mg Dosing

3-month dosing lets you monitor patients and administer treatment together at quarterly visits, as well as make timely adjustments to dosing
NDC 0074-9694-03

 

 

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Monitoring for 3-Month Administration

Response should be monitored with a GnRH stimulation test, basal LH, or serum concentration of sex steroid levels at Months 2 to 3 and at Month 6.2

  • Response should be monitored further as judged clinically appropriate to confirm maintenance of efficacy2

Height (for calculation of growth rate) and bone age should be assessed every 6-12 months.2

IMPORTANT DOSING INFORMATION

  • LUPRON DEPOT-PED must be administered by a healthcare professional.
  • Individualize the dose of LUPRON DEPOT-PED for each patient.
  • Each LUPRON DEPOT-PED strength and formulation has different release characteristics. Do not use partial syringes or a combination of syringes to achieve a particular dose. 
  • In the case of inadequate suppression of pituitary gonadotropins and peripheral sex steroids with a maximal dosage, consider other available GnRH agonists indicated for the treatment of CPP.
  • Discontinue LUPRON DEPOT-PED at the appropriate age of onset of puberty.

 

Recommended Dosage and Monitoring

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 need to be adjusted with changes in body weight.

Monitor response with a GnRH stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, with changing doses, or further as judged clinically appropriate in order to confirm maintenance of efficacy.

Assess height for calculation of growth rate and bone age every 6 to 12 months.

LUPRON DEPOT-PED for 3-month Administration2

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

Monitor response with a GnRH stimulation test, basal LH, or serum concentration of sex steroid levels at Months 2 to 3, Month 6, and further as judged clinically appropriate in order to confirm maintenance of efficacy.

Assess height for calculation of growth rate and bone age every 6 to 12 months.

ADMINISTRATION

  • Administer LUPRON DEPOT-PED as a single-dose intramuscular injection into the gluteal area, anterior thigh, or shoulder.
  • Rotate injection sites within the same region from one injection to the next.
  • Inject immediately after reconstitution. Discard if not used within 2 hours.

LEARN MORE ABOUT THE PREFILLED DUAL-CHAMBER SYRINGE WITH LUPROLOC® SAFETY DEVICE

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  • Injection site reactions, including abscess, injection site pain, and injection site swelling* occurred in ≥2% of patients with CPP in clinical trials.
*Most events were mild or moderate in severity.

Key Features

  1. Fine 23-gauge 1.5" needle on all LUPRON DEPOT-PED doses2
  2. LuproLoc® safety device2
    • OSHA-compliant mechanism helps prevent needlestick injuries4
  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

 

Both the 1- and 3-Month LUPRON DEPOT-PED Formulations Use Microsphere Technology2

  • The active drug, leuprolide, is embedded in microcapsules composed of biodegradable, hydrophobic polymers to overcome high solubility in body fluids and rapid excretion in vivo5
    • 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 injection5
    • Bioerosion phase: during erosion of the biodegradable polymer5

LUPRON DEPOT Mechanism of Drug Release5

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Visual interpretation of micosphere drug release.5

 

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.

Mean Peak Leuprolide Plasma Concentrations Following a Single Dose

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 doses
  • The mean leuprolide concentrations for 3 months after the first and second injections were similar, indicating no accumulation of leuprolide from repeated administration