InjectionClinical Overview
Leuprolide Acetate Depot Injection (3.75mg) is a synthetic nonapeptide gonadotropin-releasing hormone (GnRH / LHRH) superagonist on the WHO Model List of Essential Medicines. Following an initial transient surge in LH and FSH release (the "tumor flare" phenomenon lasting 1-2 weeks), continuous non-pulsatile administration profoundly downregulates pituitary GnRH receptors. Within 2 to 4 weeks, pituitary LH and FSH secretion is extinguished, suppressing testicular testosterone synthesis to surgical castration levels (<=50 ng/dL) in men and ovarian estradiol production to postmenopausal levels in women. Indicated for palliative treatment of advanced prostate cancer, central precocious puberty, endometriosis, and uterine leiomyomata (fibroids).
Active Pharmaceutical Ingredients
Verified Clinical References
Usage Guidelines
Administer by intramuscular (IM) or subcutaneous (SC) injection into the gluteus or abdomen once every 4 weeks (monthly depot). Must be reconstituted immediately before injection using the provided vehicle. In men with metastatic prostate cancer, co-administer an oral antiandrogen (e.g. bicalutamide) starting before leuprolide to prevent clinical symptoms of the initial testosterone surge.
General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.
Possible Side Effects
Common: Hot flashes/sweats, initial disease flare (transient increase in bone pain, urinary obstruction), erectile dysfunction, loss of libido, gynecomastia, fatigue, injection site pain. Rare/Severe: Spinal cord compression / ureteral obstruction during initial flare, pituitary apoplexy, QT prolongation, and osteoporosis.
*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.
Precautions & Warnings
Black Box Warning: Initial tumor flare can cause fatal spinal cord compression, acute urinary obstruction, or bone pain in patients with vertebral metastases; co-administer antiandrogens for the first 2 to 4 weeks. Long-term therapy causes significant bone mineral loss; monitor bone density.
Schedule H (Prescription Required)
This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.
Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, oncological diagnosis, or chemotherapy protocol guidance. Cancer therapies require specialized administration under the direct supervision of a registered medical oncologist in an accredited healthcare facility.