Lupron Depot Pediatric

Lupron Depot Pediatric

INDICATIONS

LUPRON DEPOT-PED is indicated in the treatment of children with central precocious puberty (CPP).

CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years of age in girls and 9 years of age in boys) associated with pubertal pituitary gonadotropin activation. It may show a significantly advanced bone age that can result in diminished adult height.

Prior to initiation of treatment a clinical diagnosis of CPP should be confirmed by measurement of blood concentrations of luteinizing hormone (LH) (basal or stimulated with a GnRH analog), sex steroids, and assessment of bone age versus chronological age. Baseline evaluations should include height and weight measurements, diagnostic imaging of the brain (to rule out intracranial tumor), pelvic/testicular/adrenal ultrasound (to rule out steroid secreting tumors), human chorionic gonadotropin levels (to rule out a chorionic gonadotropin secreting tumor), and adrenal steroid measurements to exclude congenital adrenal hyperplasia.

DOSAGE AND ADMINISTRATION

Dose and Principles of Dosing

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.

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.

1. 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 prior to mixing with the diluent. The diluent should appear clear.

2. To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn.

screw the white plunger into the end stopper - Illustration

3. 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.

Hold the syringeupright  - Illustration

4. Keep the syringe UPRIGHT. Mix the microspheres (powder) thoroughly by gently shaking the syringe until the powder forms 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.

Mix the microspheres -Illustration

5. Hold the syringe UPRIGHT. With the opposite hand pull the needle cap upward without twisting.

6. Keep the syringe UPRIGHT. Advance the plunger to expel the air from the syringe. Now the syringe is ready for injection.

7. After cleaning the injection site with an alcohol swab, the intramuscular injection should be performed by inserting the needle at a 90 degree angle into the gluteal area, anterior thigh, or shoulder; injection sites should be alternated.

Insert the needle at a 90 degree angle - Illustration

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. If blood is present remove the needle immediately. Do not inject the medication.

Aspirated blood would be visible just below the luer lock connection - Illustration

8. 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.

After Injection

9. Withdraw the needle. Once the syringe has been withdrawn, activate immediately the LuproLoc® safety device by pushing the arrow on the lock upward towards the needle tip with the thumb or finger, as illustrated, until the needle cover of the safety device is fully extended over the needle and a CLICK is heard or felt.

Activate the LuproLoc® safety device - Illustration

Additional Information
  • Dispose of the syringe according to local regulations/procedures.

HOW SUPPLIED

Dosage Forms And Strengths

LUPRON DEPOT-PED–1 Month (7.5 mg, 11.25 mg, and 15 mg) is supplied in a prefilled dual chamber syringe.

Storage And Handling

LUPRON DEPOT-PED–1 Month is packaged as follows

Kit with prefilled dual-chamber syringe 7.5 mg NDC 0074-2108-03
Kit with prefilled dual-chamber syringe 11.25 mg NDC 0074-2282-03
Kit with prefilled dual-chamber syringe 15 mg NDC 0074-2440-03

Each syringe contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOTPED is administered as a single intramuscular injection.

Each kit contains
  • one prefilled dual-chamber syringe containing 1½ inch needle with LuproLoc® safety device
  • one plunger
  • two alcohol swabs
  • a complete prescribing information enclosure

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]

Manufactured for Abbott Laboratories North Chicago, IL 60064 by Takeda Pharmaceutical Company Limited Osaka, Japan 540-8645

Last reviewed on RxList: 10/21/2011
This monograph has been modified to include the generic and brand name in many instances.

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