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Leuprolide Acetate (Lupron Depot)

Trade Name : Lupron Depot

AbbVie Inc.

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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) 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

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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 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration (leuprolide acetate) are indicated in the palliative treatment of advanced prostatic cancer.
  • LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for:
  • palliative treatment of advanced prostatic cancer. n
  • LUPRON DEPOT must be administered under the supervision of a physician.
  • In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of and metastatic castration-resistant prostate cancer.
  • LUPRON DEPOT must be administered under the supervision of a physician. Due to different release characteristics, the dosage strengths are not additive and must be selected based upon the desired dosing schedule. n
  • LUPRON DEPOT 7.5 mg for 1-month administration, given as a single intramuscular injection every 4 weeks. n
  • LUPRON DEPOT 22.5 mg for 3-month administration, given as a single intramuscular injection every 12 weeks. n
  • LUPRON DEPOT 30 mg for 4-month administration, given as a single intramuscular injection every 16 weeks. n
  • LUPRON DEPOT 45 mg for 6-month administration, given as a single intramuscular injection every 24 weeks. n
  • LUPRON DEPOT 7.5 mg for 1-month administration, 22.5 mg for 3-month administration, 30 mg for 4-month administration, and 45 mg for 6-month administration are each supplied as a kit with prefilled dual chamber syringe.
  • 7.5 mg, 22.5 mg, 30 mg, and 45 mg injections in a kit with prefilled dual chamber syringe. n
  • LUPRON DEPOT is contraindicated in:
  • Hypersensitivity to GnRH, GnRH agonist or any of the excipients in LUPRON DEPOT. n
  • No data
  • Increased serum testosterone (~ 50% above baseline) during first week of treatment; monitor serum testosterone and PSA. , n n
  • Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. n
  • Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice. n
  • Effect on QT/QTc Interval: Androgen deprivation therapy may prolong the QT interval. Consider risks and benefits. n
  • Convulsions have been observed in patients with or without a history of predisposing factors. Manage convulsions according to the current clinical practice. n
  • Embryo-Fetal Toxicity: LUPRON DEPOT may cause fetal harm. n n
  • The following is discussed in more detail in other sections of the labeling:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • In postmarketing experience, mood swings, depression, rare reports of suicidal ideation and attempt, rare reports of pituitary apoplexy, and rare reports of serious drug-induced liver injury have been reported. 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
  • LUPRON DEPOT 7.5 mg for 1-month administration: The most common adverse reactions (>10%) were general pain, hot flashes/sweats, GI disorders, edema, respiratory disorder, urinary disorder. n
  • LUPRON DEPOT 22.5 mg for 3-month administration: The most common adverse reactions (>10%) were general pain, injection site reaction, hot flashes/sweats, GI disorders, joint disorders, testicular atrophy, urinary disorders. n
  • LUPRON DEPOT 30 mg for 4-month administration: The most common adverse reactions (>10%) were asthenia, flu syndrome, general pain, headache, injection site reaction, hot flashes/sweats, GI disorders, edema, skin reaction, urinary disorders. n
  • LUPRON DEPOT 45 mg for 6-month administration: The most common adverse reactions (>10%) were hot flush, injection site pain, upper respiratory infection, and fatigue. n
  • No pharmacokinetic-based drug-drug interaction studies have been conducted with LUPRON DEPOT.
  • Administration of LUPRON DEPOT in therapeutic doses results in suppression of the pituitary-gonadal system. Normal function is usually restored within three months after treatment is discontinued. Due to the suppression of the pituitary-gonadal system by LUPRON DEPOT, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to three months after discontinuation of LUPRON DEPOT may be affected.
  • No data
  • Females and males of reproductive potential: LUPRON DEPOT may impair fertility. Counsel patients on pregnancy planning and prevention. n
  • Pediatric: These LUPRON DEPOT formulations are not indicated for use in children. See the LUPRON DEPOT PED package insert for the use of leuprolide acetate in children with central precocious puberty.
  • Geriatric: This label reflects clinical trials for LUPRON DEPOT in prostate cancer in which the majority of the subjects studied were at least 65 years of age.
  • There is no experience of overdosage in clinical trials. In rats, a single subcutaneous dose of 100 mg/kg (approximately 4,000 times the estimated daily human dose based on body surface area), resulted in dyspnea, decreased activity, and excessive scratching. In early clinical trials with daily subcutaneous leuprolide acetate, 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.
  • Leuprolide acetate is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH). 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 7.5 mg for 1-month administration is available in a prefilled dual-chamber syringe containing sterile lyophilized microspheres which, when mixed with diluent, becomes a suspension intended as a monthly intramuscular injection.
  • The front chamber of LUPRON DEPOT 7.5 mg for 1-month administration prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 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 22.5 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 22.5 mg for 3-month administration prefilled dual-chamber syringe contains leuprolide acetate (22.5 mg), polylactic acid (198.6 mg) and D-mannitol (38.9 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.
  • LUPRON DEPOT 30 mg for 4-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 30 mg for 4-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.
  • LUPRON DEPOT 45 mg for 6-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 45 mg for 6-month administration prefilled dual-chamber syringe contains leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 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
  • Two-year carcinogenicity studies were conducted with leuprolide acetate 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 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. 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.
  • Genotoxicity studies were conducted with leuprolide acetate using bacterial and mammalian systems. These studies provided no evidence of mutagenic effects or chromosomal aberrations.
  • Leuprolide may reduce male and female fertility. Administration of leuprolide acetate to male and female rats at dose of 0.024, 0.24, and 2.4 mg/kg as monthly depot formulation for up to 3 months (approximately as low as 1/30 of the human dose based on body surface area using an estimated daily dose in animals and humans) caused atrophy of the reproductive organs, and suppression of reproductive function. These changes were reversible upon cessation of treatment.
  • No data
  • 1. u201cOSHA Hazardous Drugs.u201d n n
  • Each LUPRON DEPOT 7.5 mg for 1-month administration kit (NDC 0074-3642-03), 22.5 mg for 3-month administration kit (NDC 0074-3346-03), 30 mg for 4-month administration kit (NDC 0074-3683-03), 45 mg for 6-month administration kit (NDC 0074-3473-03) contains:
  • The prefilled dual-chamber syringe of LUPRON DEPOT 7.5 mg for 1-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid/glycolic acid copolymer.
  • The prefilled dual-chamber syringe of LUPRON DEPOT 22.5 mg for 3-month administration, 30 mg for 4-month administration, 45 mg for 6-month administration contains sterile lyophilized microspheres of leuprolide acetate incorporated in a biodegradable lactic acid polymer.
  • When mixed with 1 mL of accompanying diluent, LUPRON DEPOT 7.5 mg for 1-month administration is administered as a single monthly intramuscular injection.
  • When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 22.5 mg for 3-month administration is administered as a single intramuscular injection .
  • When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 30 mg for 4-month administration is administered as a single intramuscular injection .
  • When mixed with 1.5 mL of accompanying diluent, LUPRON DEPOT 45 mg for 6-month administration is administered as a single intramuscular injection .
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0Cu201330u00b0C (59u00b0Fu201386u00b0F) [See USP Controlled Room Temperature].
  • Hypersensitivity
  • Tumor Flare
  • Hyperglycemia and Diabetes
  • Cardiovascular Disease
  • Urogenital Disorders
  • Infertility
  • Continuation of LUPRON DEPOT Treatment
  • Manufactured forAbbVie Inc.North Chicago, IL 60064by Takeda Pharmaceutical Company LimitedOsaka, Japan 540-8645
  • 03-B906 March 2019
  • NDC 0074-3473-03
  • FOR ADULT USE
  • 45 mg for 6-month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LupronDepotn
  • (Leuprolide Acetate for Depot Suspension)
  • 45 mg for 6-month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains: leuprolide acetate 45 mg
  • u2022 polylactic acid 169.9 mg u2022 D-mannitol 39.7 mg u2022 stearic acid 10.1 mg
  • The second chamber contains: carboxymethylcellulose sodium 7.5 mg
  • u2022 D-mannitol 75.0 mg u2022 polysorbate 80 1.5 mg u2022 water for injection, USP,
  • and glacial acetic acid, USP to control pH
  • Rx only
  • NDC 0074-3346-03
  • FOR ADULT USE
  • 22.5 mg for 3-month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LupronDepotn
  • (Leuprolide Acetate for Depot Suspension)
  • 22.5 mg for 3-month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains: leuprolide acetate 22.5 mg
  • u2022 polylactic acid 198.6 mg u2022 D-mannitol 38.9 mg
  • The second chamber contains: carboxymethylcellulose sodium 7.5 mg
  • u2022 D-mannitol 75.0 mg u2022 polysorbate 80 1.5 mg u2022 water for injection, USP,
  • and glacial acetic acid, USP to control pH
  • Rx only
  • NDC 0074-3683-03
  • FOR ADULT USE
  • 30 mg for 4-month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LupronDepotn
  • (Leuprolide Acetate for Depot Suspension)
  • 30 mg for 4-month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains: leuprolide acetate 30 mg
  • u2022 polylactic acid 264.8 mg u2022 D-mannitol 51.9 mg
  • The second chamber contains: carboxymethylcellulose sodium 7.5 mg
  • u2022 D-mannitol 75.0 mg u2022 polysorbate 80 1.5 mg u2022 water for injection, USP,
  • and glacial acetic acid, USP to control pH
  • Rx only
  • NDC 0074u20133642u201303
  • FOR ADULT USE 7.5 mg for 1u2013month administration
  • Single Dose Administration Kit with prefilled dual-chamber syringe.
  • LupronDepotn
  • (Leuprolide Acetate for Depot Suspension)
  • 7.5 mg for 1u2013month administration
  • FOR INTRAMUSCULAR INJECTION
  • The front chamber contains:
  • The second chamber contains:
  • Rx only

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