Lupron Depot-ped

Lupron Depot-ped Manufacturers

• Remedyrepack Inc.
  

  ×

  Lupron Depot-ped | Remedyrepack Inc.

  

  ---

  LUPRON DEPOT-PED is administered as a single intramuscular injection. The starting dose 7.5 mg, 11.25 mg, or 15 mg for 1-month administration is based on the child’s weight. (2) LUPRON DEPOT-PED is administered as a single intramuscular injection. The doses are either 11.25 mg or 30 mg for 3-month administration.(2) Hormonal and clinical parameters should be monitored during treatment to ensure adequate suppression. (2) The injection site should be varied periodically. (2)

   

  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.

   

  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.

   

  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. 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. 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. 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. 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.
  Now the syringe is ready for injection. 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.

  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.

  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

  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.

   

  ADDITIONAL INFORMATION

  Dispose of the syringe according to local regulations/procedures.

   

  Close
  No Recall

  More Info
• Abbvie Inc.
  

  ×

  Lupron Depot-ped | Abbvie Inc.

  

  ---

  2.1 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.

  2.2 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.

  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. 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. 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. 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. 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.
  Now the syringe is ready for injection. 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.

  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.

  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

  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. 2.2 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.

  ADDITIONAL INFORMATION

  Dispose of the syringe according to local regulations/procedures.

  Close
  No Recall

  More Info