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Leuprolide Acetate (Lupron Depot-Ped)

Trade Name : Lupron Depot-PED

AbbVie Inc.

KIT

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Leuprolide Acetate (Lupron Depot-Ped) which is also known as Lupron Depot-PED and Manufactured by AbbVie Inc.. It is available in strength of per ml. Read more

Leuprolide Acetate (Lupron Depot-Ped) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • 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.
  • LUPRON DEPOT-PED is a gonadotropin releasing hormone (GnRH) agonist indicated in the treatment of children with central precocious puberty. n
  • No data
  • 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 childu2019s weight. n
  • LUPRON DEPOT-PED is administered as a single intramuscular injection. The doses are either 11.25 mg or 30 mg for 3-month administration.n
  • Hormonal and clinical parameters should be monitored during treatment to ensure adequate suppression.n
  • The injection site should be varied periodically.n
  • ADDITIONAL INFORMATION
  • 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.
  • 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 are provided in a prefilled dual chamber syringe for intramuscular injection. n
  • No data
  • Hypersensitivity reactions. n
  • Pregnancy. n n
  • No data
  • An increase in clinical signs and symptoms of puberty may be observed during the first 2-4 weeks of therapy since gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug before being suppressed. n
  • Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms. n
  • Convulsions have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. n
  • The most common adverse reactions with GnRH agonists including 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 are injection site reactions/pain including abscess, general pain, headache, emotional lability and hot flushes/sweating.
  • During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug (hormonal flare effect). Therefore, an increase in clinical signs and symptoms of puberty may be observed .
  • p20761685
  • To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or n
  • Adverse events related to suppression of endogenous sex steroid secretion may occur with LUPRON DEPOT-PED 7.5 mg, 11.25 mg, or 15 mg for 1-month administration. n n
  • In clinical studies for LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration, the most frequent (u22652 patients) adverse reactions were: injection site pain, weight increased, headache, mood altered, and injection site swelling. n
  • No pharmacokinetic-based drug-drug interaction studies have been conducted; however, drug interactions are not expected to occur .
  • Administration of LUPRON DEPOT-PED in therapeutic doses results in suppression of the pituitary-gonadal system. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to six months after discontinuation of LUPRON DEPOT-PED may be affected. Normal pituitary-gonadal function is usually restored within six months after treatment with LUPRON DEPOT-PED is discontinued.
  • No data
  • The use of LUPRON DEPOT-PED in children under 2 years is not recommended. n
  • In early clinical trials using leuprolide acetate in adult patients, doses as high as 20 mg/day for up to two years caused no adverse effects differing from those observed with the 1 mg/day dose.
  • In rats, subcutaneous administration of leuprolide acetate as a single dose 225 times the recommended human pediatric dose, expressed on a per body weight basis, resulted in dyspnea, decreased activity, and local irritation at the injection site. There is no evidence at present that there is a clinical counterpart of this phenomenon.
  • In cases of overdosage, standard of care monitoring and management principles should be followed.
  • Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt) with the following structural formula:
  • LUPRON DEPOT-PED 7.5 mg, 11.25 mg, or 15 mg for 1-month administration
  • LUPRON DEPOT-PED is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as a single intramuscular injection.
  • The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg prefilled dual-chamber syringe contains leuprolide acetate (7.5/11.25/15 mg), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic acids copolymer (66.2/99.3/132.4 mg), and D-mannitol (13.2/19.8/26.4 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, and glacial acetic acid, USP to control pH.
  • LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration
  • LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, become a suspension intended as an intramuscular injection to be given .
  • The front chamber of LUPRON DEPOT-PED 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (11.25 mg), polylactic acid (99.3 mg) and D-mannitol (19.45 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.
  • The front chamber of LUPRON DEPOT-PED 30 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (30 mg), polylactic acid (264.8 mg) and D-mannitol (51.9 mg). The second chamber of diluent contains carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.
  • No data
  • A two-year carcinogenicity study was conducted in rats and mice. In rats, a dose-related increase of benign pituitary hyperplasia and benign pituitary adenomas was noted at 24 months when the drug was administered subcutaneously at high daily doses (0.6 to 4 mg/kg). There was a significant but not dose-related increase of pancreatic islet-cell adenomas in females and of testicular interstitial cell adenomas in males (highest incidence in the low dose group). In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years. Adult patients have been treated with leuprolide acetate for up to three years with doses as high as 10 mg/day and for two years with doses as high as 20 mg/day without demonstrable pituitary abnormalities.
  • Following subcutaneous administration of LUPRON DEPOT to male and female rats before mating there was atrophy of the reproductive organs and suppression of reproductive performance.
  • Following a study with leuprolide acetate, immature male rats demonstrated tubular degeneration in the testes even after a recovery period. In spite of the failure to recover histologically, the treated males proved to be as fertile as the controls. Also, no histologic changes were observed in the female rats following the same protocol. In both sexes, the offspring of the treated animals appeared normal. The effect of the treatment of the parents on the reproductive performance of the F1 generation has been evaluated using LUPRON DEPOT formulation to groups of rats as one-time subcutaneous dose of 0.024 mg/kg (1/19 of the pediatric dose) on Day 15 of gestation or dosing on parturition day at doses up to 8 mg/kg (18 fold of the pediatric dose). There was no effect on growth, morphological development and reproductive performance of F1 generation.
  • No data
  • LUPRON DEPOT-PED prefilled syringe for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer.
  • LUPRON DEPOT-PED prefilled syringe for 3-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.
  • When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single intramuscular injection. When mixed with 1.5 milliliter of accompanying diluent, LUPRON DEPOT-PED for 3-month administration is administered as a single intramuscular injection.
  • Each kit contains:
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15-30u00b0C (59-86u00b0F) [See USP Controlled Room Temperature]
  • Information for Caregivers
  • Prior to starting therapy with LUPRON DEPOT-PED, patients should be informed that:
  • Manufactured for AbbVie Inc. North Chicago, IL 60064 by Takeda Pharmaceutical Company Limited Osaka, Japan 540-8645
  • 03-B510 May, 2017
  • 03-B510
  • NDC 0074u20132282u201303
  • PEDIATRIC USE ONLY 11.25 mg for 1-month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LUPRON DEPOT-PEDn
  • (Leuprolide Acetate for Depot Suspension)
  • Dispense the accompanying Medication Guide to each patient.
  • 11.25 mg for 1-month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains:
  • The second chamber contains:
  • Rx only
  • NDC 0074u20133779u201303
  • PEDIATRIC USE ONLY 11.25 mg for 3-month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension)
  • Dispense the accompanying Medication Guide to each patient.
  • 11.25 mg for 3u2013month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains:
  • The second chamber contains:
  • Rx only
  • NDC 0074u20139694u201303
  • PEDIATRIC USE ONLY 30 mg for 3-month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe
  • LUPRON DEPOT-PEDn
  • (Leuprolide Acetate for Depot Suspension)
  • 30 mg for 3-month administration
  • FOR INTRAMUSCULAR INJECTION
  • Dispense the accompanying Medication Guide to each patient.
  • The front chamber contains:
  • The second chamber contains:
  • Rx only
  • NDC 0074u20132108u201303
  • PEDIATRIC USE ONLY 7.5 mg for 1-month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LUPRON DEPOT-PEDn
  • (Leuprolide Acetate for Depot Suspension)
  • Dispense the accompanying Medication Guide to each patient.
  • 7.5 mg for 1-month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains:
  • The second chamber contains:
  • Rx only
  • NDC 0074u20132440u201303
  • PEDIATRIC USE ONLY 15 mg for 1-month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LUPRON DEPOT-PEDn
  • (Leuprolide Acetate for Depot Suspension)
  • Dispense the accompanying Medication Guide to each patient.
  • 15 mg for 1-month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains:
  • The second chamber contains:
  • Rx only

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