DOSAGE AND ADMINISTRATION
Dose and Principles of Dosing 7.5 mg, 11.25 mg, or 15 mg for 1-month administration
LUPRON DEPOT-PED must be administered under the supervision of a physician.
LUPRON DEPOT-PED is administered as a single intramuscular injection once a month. The starting dose will be dictated by the child's weight, as indicated in the table below.
Table 1. 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 (e.g. 11.25 mg or 15 mg at the next monthly injection). Similarly, the dose may be adjusted with changes in body weight. The injection site should be varied periodically.
The goal of therapy is to suppress pituitary gonadotropins and peripheral sex steroids, and to arrest progression of secondary sexual characteristics. Hormonal and clinical parameters should be monitored after 1–2 months of initiating therapy and with each dose change to ensure adequate pituitary gonadotropin suppression. Once a dose that results in adequate hormonal suppression is found, it can often be maintained for the duration of therapy in most children. It is recommended, however, that adequate hormonal suppression be verified in such patients as weight can increase significantly while on therapy.
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.
LUPRON DEPOT-PED should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.
For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.3.
Dose and Principles of Dosing 11.25 mg or 30 mg for 3-month administration
LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration must be administered under the supervision of a physician.
LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration should be administered once every three months (12 weeks) as a single intramuscular injection. Regardless of the dose chosen, the goal of therapy is to suppress pituitary gonadotropins and peripheral sex steroids, and to arrest progression of secondary sexual characteristics. Hormonal and clinical parameters should be monitored during treatment, for instance at month 2-3, month 6 and further as judged clinically appropriate, to ensure adequate suppression. In case of inadequate suppression, other available GnRH agonists indicated for the treatment of CPP should be considered.
Each LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration strength and formulation has different release characteristics. Do not use partial syringes or a combination of syringes to achieve a particular dose.
LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration treatment should be discontinued at the appropriate age of onset of puberty at the discretion of the physician.
For optimal performance of the prefilled dual chamber syringe (PDS), read and follow the instructions in Section 2.3
.
Reconstitution and Administration Instructions
- The lyophilized microspheres are to be reconstituted and administered as a single intramuscular injection.
- Since LUPRON DEPOT-PED does not contain a preservative, the suspension should be injected immediately or discarded if not used within two hours.
- As with other drugs administered by injection, the injection site should be varied periodically.
ADDITIONAL INFORMATION
- Dispose of the syringe according to local regulations/procedures.
DOSAGE FORMS AND STRENGTHS
LUPRON DEPOT-PED 7.5 mg, 11.25 mg, or 15 mg for 1-month administration and LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is provided in a prefilled dual chamber syringe for intramuscular injection.
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