Description:
Luprodex (3.75 mg) is a depot injection formulation of leuprolide acetate, a gonadotropin‑releasing hormone (GnRH) agonist. It works by initially stimulating, then subsequently downregulating, GnRH receptors in the pituitary, leading to reduced secretion of luteinizing hormone (LH) and follicle‑stimulating hormone (FSH). The result is decreased ovarian estrogen production in women, and reduced testosterone production in men. It is used in conditions such as prostate cancer, endometriosis, uterine fibroids, and central precocious puberty.

 Prescription:

• Prescription‑only

Therapeutic Category:

• Hormonal therapy

• Gonadotropin‑releasing hormone agonist (GnRH agonist)

• Antineoplastic / Endocrine therapy for hormone‑dependent conditions

 Active Ingredients / Composition:

• Active Ingredient: Leuprolide Acetate (sometimes called leuprorelin) 3.75 mg per dose in the depot form.

• Form: Lyophilized powder for depot injection (freeze‑dried) to be reconstituted with a diluent (often provided as ampoule) before administration.

Variant:

• This is the depot 3.75 mg monthly version. Other strengths/variants exist, such as 11.25 mg (3‑monthly), 22.5 mg, etc.

• Administered either intramuscularly (IM) or subcutaneously (SC) depending on the protocol.

Consume Type :

• Injectable, depot form.

 Directions / Usage:

• The dose is 3.75 mg every 4 weeks (one month) for many indications (e.g., endometriosis, uterine fibroids, prostate cancer).

• Duration depends on disease: e.g. up to 6 months in endometriosis/fibroids; for prostate cancer, often longer until disease control is achieved.

• Pediatric dosing for central precocious puberty: specific weight/age protocol to suppress puberty.

 Common Side Effects:
These are side effects often seen with leuprolide (GnRH agonists) including:

• Hot flashes, sweating, flushes

• Injection site reactions (pain, swelling, etc.)

• Headache, dizziness, fatigue

• Mood changes, depression, emotional disturbances

• Menstrual irregularities, amenorrhea (absence of periods) in women

• Reduced libido, impotence in men

• Bone mineral density loss / osteoporosis with long‑term use

 Package Type:

• Supplied as a vial of the freeze‑dried (lyophilized) powder plus an ampoule of diluent for reconstitution. For example: 1 vial + 1 × 2 mL ampoule.

Storage Advice:

• Store under refrigeration (2‑8 °C). Protect from light.

• Keep frozen powder in original vial; reconstitute before use. Once reconstituted, follow directions regarding how stable it remains.

• Keep out of reach of children.

Safety Advice:

• Women who are pregnant, planning pregnancy, or breastfeeding should avoid use; may cause harm.

• Use contraception during treatment as fertility suppression occurs.

• Monitor bone health in long‑term treatment due to risk of bone loss. May need calcium and Vitamin D supplementation.

• Be cautious in patients with cardiovascular disease, depression, diabetes, liver or kidney dysfunction.

• Avoid in individuals with hypersensitivity to leuprolide or any component of the formulation.

Product Substitutes:

• Other brands/generics of leuprolide acetate (e.g., Lupron Depot, Prostap, etc.) in similar dosing schedules.

• Alternative GnRH agonists (like goserelin, triptorelin) depending on clinical guidelines and availability.

Manufacturer / Marketer:

• Bharat Serums & Vaccines Ltd.

 Country of Origin:

• India.