Lupron Depot-PED® & Central Precocious Puberty: Dosing and Administration

Dosing and Administration of Lupron Depot-PED

Adequate dosing of Lupron Depot-PED is essential for optimal management of CPP. Inadequate dosing stimulates the release of gonadotropins, allowing continued sexual development; therefore, adherence to a 4-week dosing interval must be maintained.

Because every child is unique, the dose must be individualized to each child based on a mg/kg ratio of drug to body weight. Younger children require higher doses on a mg/kg ratio. Hormone levels need to be continuously monitored in order to ensure total downregulation is achieved. Lupron Depot-PED offers 3 dosing options (7.5 mg, 11.25 mg, 15 mg) to ensure adequate dosing for every child. Injection of adequate doses of GnRH agonist at 4-week intervals downregulates the pituitary-gonadal axis.

Starting Dose

The recommended starting dose is 0.3 mg/kg every 4 weeks (minimum 7.5 mg) administered as a single intramuscular injection. The starting dose will be dictated by the child's weight.


Child's Weight	Starting Dose
≤25 kg	7.5 mg
>25-37.5 kg	11.25 mg
>37.5 kg	15 mg

The first dose found to result in adequate downregulation can probably be maintained for the duration of therapy in most children. However, there are insufficient data to guide dosage adjustment as patients move into higher weight categories after beginning therapy at very young ages and low dosages. It is recommended that adequate downregulation be verified in such patients whose weight had increased significantly while on therapy.

Dose Titration

After 1-2 months of initiating therapy or changing doses, the child must be monitored with a GnRH stimulation test, sex steroids, and Tanner staging to confirm downregulation. Measurements of bone age for advancement should be monitored every 6-12 months. The dose should be titrated upward until no progression of the condition is noted either clinically and/or by laboratory parameters.

Administration of Lupron Depot-PED

Lupron Depot-PED must be administered under the supervision of a physician, with injections usually provided every 4 weeks. For all formulations of Lupron Depot-PED, the lyophilized microspheres are to be reconstituted and administered as follows.

Preparing for Injection

The Lupron Depot-PED powder should be visually inspected and the syringe should NOT BE USED if clumping or caking is evident. A thin layer of powder on the wall of the syringe is considered normal. The diluent should appear clear.

	To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn. Hold the syringe UPRIGHT.
	Release the diluent by SLOWLY PUSHING (6 to 8 seconds) the plunger until the first stopper is at the blue line in the middle of the barrel.
	Keep the syringe UPRIGHT. Gently mix the microspheres (powder) thoroughly to form a uniform suspension. The suspension will appear milky.
	If the powder adheres to the stopper or caking/clumping is present, tap the syringe with your finger to disperse. DO NOT USE if any of the powder has not gone into suspension.
	Hold the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe.

Injection

Inject the entire contents of the syringe intramuscularly at the time of reconstitution. The suspension settles very quickly following reconstitution; therefore, Lupron Depot-PED should be mixed and used immediately.

NOTE: Aspirated blood would be visible just below the luer lock connection if a blood vessel is accidentally penetrated. If present, blood can be seen through the transparent LuproLoc™ safety device.

After Injection

Withdraw the needle. Immediately activate the LuproLoc™ safety device, by pushing the arrow forward with the thumb or finger until the device is fully extended and a CLICK is heard or felt.

Since the product does not contain a preservative, the suspension should be discarded if not used immediately. As with other drugs administered by injection, the injection site should be varied periodically.

Read the safety information for Lupron Depot-PED