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Leuprolide Acetate (Lupron Depot)

Trade Name : Lupron Depot

AbbVie Inc.

KIT

Strength

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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

Leuprolide Acetate (Lupron Depot) 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

Packaging and Delivery

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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.

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About GNH

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
  • Reconstitute leuprolide acetate prior to use. n
  • Endometriosis:
  • Fibroids:
  • LUPRON DEPOT (leuprolide acetate for depot suspension) 11.25 mg for 3-month administration contains leuprolide acetate and is a lyophilized powder for reconstitution with supplied diluent in a prefilled dual chamber syringe.
  • Depot suspension for injection: 11.25 mg lyophilized powder for reconstitution in a dual-chamber syringe. n
  • LUPRON DEPOT 11.25 mg is contraindicated in women with the following:
  • When considering add-back therapy with norethindrone acetate, refer also to in the norethindrone acetate package insert.
  • When add-back therapy with norethindrone acetate is considered, refer also to Contraindications in the norethindrone acetate package insert. n
  • Hypersensitivity to GnRH, GnRH agonist or any of the excipients in LUPRON DEPOT 11.25 mg. n n
  • Undiagnosed abnormal uterine bleeding. n
  • Pregnancy or suspected pregnancy. , n
  • Lactation. n
  • When considering add-back therapy with norethindrone acetate, refer also to in the norethindrone acetate package insert.
  • Loss of bone mineral density: Do not exceed the labeled duration of treatment for endometriosis. Do not use more than one injection for preoperative hematologic improvement in women with fibroids. , , n
  • Exclude pregnancy before starting treatment and discontinue use if pregnancy occurs. Use non-hormonal methods of contraception only. n
  • Serious allergic reactions have been reported with LUPRON DEPOT 11.25 mg. n
  • When add-back therapy with norethindrone acetate is used, refer also to Warnings and Precautions in the norethindrone acetate package insert. n
  • Most common related adverse reactions (>10%) in clinical trials were hot flashes/sweats, headache/migraine, decreased libido, depression/emotional lability, dizziness, nausea/vomiting, pain, vaginitis and weight gain. n
  • To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • No data
  • No data
  • Pediatric: Safety and effectiveness of LUPRON DEPOT for treatment of endometriosis or fibroids has not been established in females less than 18 years of age. n
  • Geriatric: LUPRON DEPOT 11.25 mg has not been studied in women over 65 years of age and is not indicated in this population. n
  • Leuprolide acetate is a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH or LH-RH), a GnRH agonist. 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 11.25 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.
  • The front chamber of LUPRON DEPOT 11.25 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate for depot suspension (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.
  • During the manufacture of LUPRON DEPOT 11.25 mg for 3-month administration, acetic acid is lost, leaving the peptide.
  • 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).u00a0There 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).u00a0In mice, no leuprolide acetate-induced tumors or pituitary abnormalities were observed at a dose as high as 60 mg/kg for two years.u00a0Patients 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.
  • Mutagenicity studies have been performed with leuprolide acetate using bacterial and mammalian systems.u00a0These studies provided no evidence of a mutagenic potential.
  • Clinical and pharmacologic studies in adults (> 18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when the drug is discontinued after continuous administration for periods of up to 24 weeks. Although no clinical studies have been completed in children to assess the full reversibility of fertility suppression, animal studies (pre-pubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery.
  • The safety and efficacy of LUPRON DEPOT 11.25 mg for 3-month administration for the following indications has been established based on adequate and well-controlled adult studies (See Table 8) of LUPRON DEPOT 3.75 mg for 1-month administration and on a single trial of LUPRON DEPOT 11.25 mg for 3-month administration:
  • See and for the results of the adequate and well-controlled studies in these conditions.
  • Each LUPRON DEPOT 11.25 mg kit (NDC 0074-3663-03) contains:
  • Each syringe contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable polymer of polylactic acid.u00a0When mixed with 1.5 mL of the diluent, LUPRON DEPOT 11.25 mg is administered as a single intramuscular injection.
  • Store between 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). Excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) .
  • Advise patients about the Warnings and Precautions for LUPRON DEPOT 11.25 mg, including:
  • Loss of Bone Density
  • Advise patients about the risk of loss of bone mineral density and that treatment is limited :
  • Pregnancy Warning
  • Allergic Reaction to GnRH agonists
  • Advise patients not to use this drug if they have experienced an allergic reaction to GnRH agonists n
  • New or Worsened Symptoms
  • Advise patients to notify their healthcare provider if they develop new or worsened symptoms after beginning treatment n
  • Manufactured for
  • AbbVie Inc.
  • North Chicago, IL 60064
  • by Takeda Pharmaceutical Company Limited
  • Osaka, Japan 540-8645
  • u00a92018 AbbVie Inc.
  • Revised: April 2018
  • 03-B603
  • NDC 0074-3663-03
  • FOR ADULT USE 11.25 mg for 3-Month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LupronDepotn
  • (leuprolide acetate for depot suspension)
  • 11.25 mg for 3-Month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains: leuprolide acetate 11.25 mg, polylactic acid 99.3 mg, D-mannitol 19.45 mg
  • The second chamber contains: D-mannitol 75.0 mg, carboxymethylcellulose sodium 7.5 mg, polysorbate 80 1.5 mg, water for injection, USP, and glacial acetic acid, USP to control pH
  • Rx only

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