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Leuprosun 11.25mg - Leuprolide Acetate Injection

Leuprosun 11.25mg is a long-acting GnRH agonist injection used to treat hormone-responsive cancers and conditions like prostate cancer, endometriosis, and uterine fibroids. It provides hormone suppression for up to 3 months with a single dose.

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General Information:
Generic Name: Leuprolide Acetate
Brand Name: Leuprosun 11.25mg
Packing: Single-dose vial + diluent for reconstitution
Strength: 11.25 mg
Manufacturer: Sun Pharmaceutical Industries Ltd.
Form: Injectable (Depot/Long-acting)
Category: Gonadotropin-Releasing Hormone (GnRH) Agonist / Antineoplastic Agent / Hormonal Therapy
Product Introduction:
Leuprosun 11.25mg is a depot formulation of Leuprolide Acetate, designed for extended-release over a 12-week period. It acts on the pituitary gland to suppress the release of sex hormones (testosterone and estrogen), making it effective in managing hormone-sensitive diseases. This injection is administered by a healthcare professional.

Uses:
Leuprosun 11.25mg is used for the treatment of:
  1. Advanced Prostate Cancer – suppression of testosterone
  2. Endometriosis – reduces estrogen and relieves symptoms
  3. Uterine Fibroids – helps shrink fibroids before surgery or to manage symptoms
  4. Central Precocious Puberty (CPP) – delays premature sexual development in children
  5. Breast Cancer – hormone receptor-positive cases (in premenopausal women)
  6. Fertility Treatments (IVF) – as part of ovarian stimulation protocols

Storage Instructions:
  1. Store below 25°C (77°F)
  2. Protect from light and moisture
  3. Do not freeze
  4. Use immediately after reconstitution
  5. Keep away from children

How It Works (Mechanism of Action):
Leuprolide Acetate is a GnRH agonist. It initially stimulates the release of LH and FSH, causing a temporary increase in sex hormone levels (testosterone/estrogen). However, with continued use, it downregulates the pituitary receptors, ultimately suppressing the release of LH and FSH, resulting in low hormone levels that help slow or halt the progression of hormone-sensitive conditions.

Side Effects:
Common side effects include:
  1. Hot flashes
  2. Headache
  3. Fatigue
  4. Sweating
  5. Decreased libido
  6. Vaginal dryness (in women)
  7. Injection site discomfort
Serious side effects may include:
  1. Bone loss (osteoporosis)
  2. Mood swings or depression
  3. Irregular heart rhythm (QT prolongation)
  4. High blood sugar (hyperglycemia or new-onset diabetes)
  5. Initial tumor flare-up in prostate cancer
  6. Allergic reactions (rash, difficulty breathing, swelling)

Dosage (Typical Recommended Dose):
  1. One 11.25 mg injection administered once every 3 months (12 weeks)
  2. Dosage schedule may vary depending on the indication and patient response
  3. Must be administered by a trained healthcare provider

Method of Administration:
  1. Given as a deep intramuscular (IM) or subcutaneous (SC) injection
  2. Powder must be reconstituted with provided diluent before use
  3. Administered by a healthcare professional only
  4. Injection site should be rotated if receiving multiple doses

Precautions:
  1. Not to be used during pregnancy or breastfeeding – may cause fetal harm
  2. Use non-hormonal contraception during treatment
  3. Monitor for mood changes, bone health, and cardiac function
  4. May cause temporary worsening of symptoms (tumor flare) in the initial phase
  5. Not recommended for use in patients with undiagnosed vaginal bleeding or hypersensitivity to GnRH agonists

Drug Interactions:
May interact with:
  1. QT-prolonging medications (e.g., certain antiarrhythmics, antipsychotics)
  2. Insulin or oral antidiabetics
  3. Corticosteroids
  4. Other hormone therapies or chemotherapeutic agents
    Always inform your doctor about all medicines and supplements you are taking.

Allergies:
  1. Contraindicated in individuals with a known hypersensitivity to Leuprolide Acetate, GnRH analogs, or any component of the injection
  2. Allergic reactions can range from mild (rash, itching) to severe (swelling, difficulty breathing)

Overdose Information:
  1. Overdose is rare due to depot formulation and medical administration
  2. Symptoms may include hormonal imbalance, excessive suppression effects, or side effects
  3. No specific antidote; supportive treatment is recommended

Missed Dose Instructions:
  1. If a dose is missed or delayed, contact your healthcare provider promptly
  2. Timely administration is essential to maintain hormonal suppression and therapeutic effectiveness
  3. Avoid self-adjusting the schedule

Additional Notes:
  1. Patients on long-term therapy may need bone density monitoring and calcium/vitamin D supplements
  2. Regular monitoring of hormone levels, PSA (for prostate cancer), and clinical response is necessary
  3. Inform your doctor if you experience severe mood changes, bone pain, or menstrual irregularities
  4. Carry a treatment card or medical alert indicating use of hormonal therapy
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