Multiple Dosing Options
EVEN MORE FLEXIBLE DOSING FOR INDIVIDUALIZED TREATMENT2
IMPORTANT DOSING INFORMATION2
- 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
LUPRON DEPOT-PED 1-month2
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
|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.
LUPRON DEPOT-PED 3-month2
LUPRON DEPOT-PED should be administered once every 3 months (12 weeks) as a single intramuscular injection.
LUPRON DEPOT-PED 6-month2
LUPRON DEPOT-PED should be administered once every 6 months (24 weeks) as a single intramuscular injection.
RECOMMENDED MONITORING OF YOUR PATIENTS
Monitor response with a GnRH stimulation test, basal LH, or serum concentration of sex steroid levels.2
LUPRON DEPOT-PED 1-month: At 1 to 2 months following initiation of therapy and when changing doses
LUPRON DEPOT-PED 3-month: At months 2 to 3 and at month 6
LUPRON DEPOT-PED 6-month: At months 5 to 6
For all dosing options, response should also be monitored as judged clinically appropriate to confirm maintenance of efficacy after initial monitoring.
Height (for calculation of growth rate) and bone age should be assessed every 6 to 12 months.
Please refer to the full Prescribing Information for additional monitoring information.
- 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
6 KEY FEATURES FOR EASE OF ADMINISTRATION
Key features across all LUPRON DEPOT-PED doses
- Fine 23-gauge 1.5" needle2
- LuproLoc® safety device2
- OSHA-compliant mechanism helps prevent needlestick injuries
- Prefilled dual-chamber syringe2
- No external mixing of ingredients is required
- Dosing volumes2,3
- 1-month: 1 mL
- 3-month and 6-month: 1.5 mL
- Administer within 2 hours of mixing2
- Inject immediately after reconstitution
- Discard if not used within 2 hours
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.
ALL LUPRON DEPOT-PED DOSES USE MICROSPHERE TECHNOLOGY2
- Each formulation contains sterile lyophilized microsphere powder incorporated in a biodegradable copolymer, which becomes a suspension for intramuscular injection when mixed with diluent. Once administered, leuprolide is released for the intended 1-, 3-, or 6-month dosing frequency2
- Leuprolide is released in 2 phases in vivo
- Diffusion phase: from near the surface of a swollen microsphere immediately after injection4
- Bioerosion phase: during erosion of the biodegradable polymer4
LUPRON DEPOT-PED mechanism of drug release4
PHARMACOKINETICS OF LUPRON DEPOT-PED 1-MONTH2
In a study of pediatric patients with CPP, doses of 7.5 mg, 11.25 mg, and 15 mg of LUPRON DEPOT-PED were given every 4 weeks. In 22 pediatric patients, trough leuprolide plasma levels were determined according to weight categories as summarized below:
Trough plasma leuprolide levels for 1-month dose
|Dose||Patient weight range||Group weight average||Trough plasma leuprolide level (mean±SD)a|
|7.5 mg||20.2 - 27.0 kg||22.7 kg||0.77±0.033 ng/mL|
|11.25 mg||28.4 - 36.8 kg||32.5 kg||1.25±1.06 ng/mL|
|15 mg||39.3 - 57.5 kg||44.2 kg||1.59±0.65 ng/mL|
aGroup average values determined at week 4 immediately prior to leuprolide injection. Drug levels at 12 and 24 weeks were similar to respective week 4 levels.
PHARMACOKINETICS OF LUPRON DEPOT-PED 3-MONTH2
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||At 1 hour||At 2 weeks|
|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-mg and 30-mg doses
- The mean leuprolide concentrations at 3 months after the first and second injections were similar, indicating no accumulation of leuprolide from repeated administration
PHARMACOKINETICS OF LUPRON DEPOT-PED 6-MONTH2
Mean peak leuprolide plasma concentrations following a single dose (N=20)
|Dose||At 1 hour||At 24 weeks|
|45 mg||15.7 ng/mL||0.03 ng/mL|
- Mean peak plasma leuprolide concentrations rose rapidly after a single injection, and then slowly declined by week 24. Six months after the first and second injections, mean concentrations indicated no accumulation of leuprolide from repeated administration