Molecule
Leuprolide is a gonadotropin releasing hormone receptor agonist indicated for the treatment of advanced prostate cancer. It is available as kits, extended-release injectable suspension and injectable emulsion for subcutaneous use. MedsAcross supplies Leuprolide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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 for the treatment of advanced prostate cancer. LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer.
Source: US FDA prescribing information
Leuprolide acetate, a GnRH agonist, acts as an inhibitor of gonadotropin secretion. Animal studies indicate that following an initial stimulation, continuous administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect was reversible upon discontinuation of drug therapy. Administration of leuprolide acetate has resulted in inhibition of the growth of certain hormone dependent tumors (prostatic tumors in Noble and Dunning male rats and DMBA-induced mammary tumors in female rats) as well as atrophy of the reproductive organs.
Source: US FDA prescribing information
LUPRON DEPOT must be administered by a healthcare provider. In patients treated with GnRH analogues for prostate cancer, treatment is usually continued upon development of non-metastatic and metastatic castration-resistant prostate cancer. Table 1. LUPRON DEPOT Recommended Dosing Dosage 7.5 mg for 1-Month Administration 22.5 mg for 3-Month Administration 30 mg for 4-Month Administration 45 mg for 6-Month Administration Recommended dose 1 injection every 4 weeks 1 injection every 12 weeks 1 injection every 16 weeks 1 injection every 24 weeks 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. LUPRON DEPOT 7.5 mg for 1-month administration, given as a single intramuscular injection every 4 weeks.
Source: US FDA prescribing information
LUPRON DEPOT is contraindicated in: Hypersensitivity LUPRON DEPOT is contraindicated in individuals with known hypersensitivity to GnRH agonists or any of the excipients in LUPRON DEPOT. Reports of anaphylactic reactions to GnRH agonists have been reported in the medical literature. Hypersensitivity to GnRH, GnRH agonist or any of the excipients in LUPRON DEPOT.
Source: US FDA prescribing information
Tumor Flare: Increased serum testosterone (~ 50% above baseline) may occur when initiating treatment with LUPRON DEPOT. Monitor for worsening of prostate cancer symptoms during the first few weeks of treatment. Monitor patients for increased bone pain, neuropathy, hematuria, ureteral obstruction, and spinal cord compression. Spinal cord compressions may contribute to paralysis with or without fatal complications. Metabolic Syndrome: The use of GnRH agonists may lead to an increased risk of metabolic changes such as hyperglycemia, diabetes, hyperlipidemia, and non-alcoholic fatty liver disease. Monitor for signs and symptoms of metabolic syndrome including lipids, blood glucose level and/or HbA1c and manage according to current treatment guidelines.
Source: US FDA prescribing information
The following is discussed in more detail in other sections of the labeling: Tumor Flare Metabolic Syndrome Cardiovascular Disease Effect on QT/QTc Interval Convulsions Severe Cutaneous Adverse Reactions 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. 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. 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.
Source: US FDA prescribing information
Drug/Laboratory Test Interactions 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.
Source: US FDA prescribing information
Store between 20° to 25°C (68° to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
23 presentations of Leuprolide, sorted by availability.
9 brand names across 1 markets.
Indian manufacturers are highlighted.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 9 April 1985 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Leuprolide in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 23 presentations of Leuprolide and sources them for licensed hospitals, importers and physicians against valid import documents. Indian manufacturers include Accord BioPharma, Cipla.
The catalogue lists 9 brand names for Leuprolide, including Camcevi, Camcevi Etm, Eligard, Fensolvi, Leuprolide Acetate Depot, Lupron Depot, Lupron Depot-PED, Lutrate Depot.
Yes. The US FDA first approved Leuprolide on 9 April 1985, according to Drugs@FDA.
At least one listed presentation of Leuprolide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Leuprolide is classified under ATC code L02AE02 (Leuprorelin).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.