Product Introduction:
Luprodex is an injectable depot formulation of Leuprolide Acetate, used for long-term suppression of gonadal hormone production. It is administered intramuscularly and is effective for 1 to 6 months, depending on the dosage. It is primarily prescribed for prostate cancer and gynecological conditions involving estrogen overproduction.
Uses (Indications):
Luprodex is indicated in several clinical settings:
-
Advanced Prostate Cancer – To suppress testosterone and slow cancer progression
-
Endometriosis – To reduce pelvic pain and endometrial lesions
-
Uterine Fibroids – Used to shrink fibroids and reduce bleeding, especially pre-surgery
-
Central Precocious Puberty (CPP) – To delay early onset of puberty in children
-
Breast Cancer (Off-label in premenopausal women) – To suppress estrogen production
-
Assisted Reproductive Technology (ART) – To control ovulation cycles and improve IVF outcomes
Storage Instructions:
-
Store below 25°C in a dry place away from direct sunlight
-
Do not freeze the vial or diluent
-
Reconstituted solution should be used immediately
-
Keep out of reach of children
-
Dispose of used vials and syringes according to biomedical waste protocols
How It Works (Mechanism of Action):
Leuprolide Acetate mimics gonadotropin-releasing hormone (GnRH) and initially stimulates the pituitary to secrete luteinizing hormone (LH) and follicle-stimulating hormone (FSH), temporarily raising sex hormone levels (a flare effect). With continued use, pituitary GnRH receptors are downregulated, leading to suppression of LH and FSH, and thereby reducing testosterone in males and estrogen in females. This hormonal suppression is critical in slowing hormone-driven tumor growth and alleviating symptoms in gynecologic disorders.
Side Effects:
Common Side Effects:
-
Hot flashes and sweating
-
Headache and fatigue
-
Decreased libido or erectile dysfunction
-
Vaginal dryness in women
-
Injection site pain or redness
-
Mood swings or depression
Severe Side Effects:
-
Tumor flare symptoms in prostate cancer (bone pain, urinary issues)
-
Osteoporosis with long-term use
-
Seizures in susceptible individuals
-
QT interval prolongation leading to arrhythmias
-
Anaphylaxis or severe allergic reaction (rare)
-
Risk of pituitary apoplexy in patients with pituitary adenomas
Dosage (Typical Recommended Dose):
Prostate Cancer:
-
Luprodex 11.25 mg IM every 3 months
-
Luprodex 22.5 mg IM every 6 months
Endometriosis / Uterine Fibroids:
-
3.75 mg monthly or 11.25 mg every 3 months, limited to 6 months of use
Central Precocious Puberty:
-
Weight-based dosing, typically 11.25 mg every 3 months
Note: Dosage may vary depending on age, indication, and clinical monitoring. Always follow physician's prescription.
Method of Administration:
-
Administered as a deep intramuscular injection into the gluteal muscle
-
Reconstitute the lyophilized powder using the provided diluent
-
Administer immediately after preparation
-
Injection should be given by a trained healthcare professional
-
Monitor for signs of allergic reaction post-injection
Precautions:
-
Tumor flare risk – Consider anti-androgen therapy during initiation in prostate cancer
-
Monitor bone mineral density if used longer than 6 months
-
Contraindicated during pregnancy – Category X
-
Use with caution in patients with cardiovascular disease or diabetes
-
Monitor mood and psychological symptoms; may cause depression or emotional changes
-
May cause growth suppression in children if misused
Drug Interactions:
-
QT-prolonging medications (e.g., methadone, quinolones) – increased cardiac risk
-
Antidiabetic agents – may alter glycemic control
-
Corticosteroids – synergistic effect on bone loss
-
Hormonal contraceptives – effectiveness reduced
-
CNS depressants – may enhance sedation or confusion in elderly patients
Allergies (Warnings for Allergic Reactions):
-
Contraindicated in patients with known hypersensitivity to Leuprolide, GnRH, or its analogs
-
Symptoms of allergic reactions include rash, itching, hives, breathing difficulties, or swelling
-
Anaphylaxis, although rare, may occur and requires immediate emergency care
-
Discontinue use at first signs of serious allergic reaction
Overdose Information:
-
Overdose is extremely rare due to depot injection
-
Symptoms may include excessive hormonal suppression or prolonged side effects
-
Supportive and symptomatic treatment is recommended
-
Immediate medical attention is necessary in case of suspected overdose
Missed Dose Instructions:
-
Administer missed dose as soon as possible
-
Maintain the recommended interval between injections
-
Do not double up or adjust schedule without medical consultation
-
Delayed doses may reduce treatment effectiveness; schedule adherence is critical
Additional Notes:
-
Calcium and Vitamin D supplementation may be advised during long-term use
-
Patients should be counseled about menopausal symptoms (females) and sexual side effects (males)
-
Regular monitoring with PSA levels, testosterone/estradiol, and bone scans may be necessary
-
Discuss family planning; fertility may be affected during and after therapy
-
Therapy is reversible, but return of hormone function may be delayed after discontinuation
