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Bdsure (11.25mg / 22.5mg) - Leuprolide Acetate Injection

Bdsure (11.25mg / 22.5mg) - Leuprolide Acetate Injection

Bdsure is a GnRH agonist injection used in the treatment of hormone-responsive cancers such as prostate and breast cancer, as well as gynecological conditions like endometriosis and uterine fibroids. It works by suppressing the production of sex hormones.

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Description Product Details
General Information:
Generic Name: Leuprolide Acetate
Brand Name: Bdsure
Strengths Available: 11.25mg (3-month depot), 22.5mg (6-month depot)
Packing: Single-dose vial with diluent
Manufacturer: Bdr Pharmaceuticals Internationals Pvt Ltd
Form: Lyophilized powder for IM injection
Category: Hormonal therapy / GnRH agonist / Oncology
Product Introduction:
Bdsure contains Leuprolide Acetate, a synthetic gonadotropin-releasing hormone agonist that causes an initial surge followed by a long-term suppression of LH and FSH, leading to reduced testosterone and estrogen levels. It is administered intramuscularly as a depot formulation that provides sustained release over weeks or months.
Uses:
Bdsure is indicated for:
  1. Advanced prostate cancer
  2. Endometriosis
  3. Uterine fibroids (as pre-surgical adjunct)
  4. Central precocious puberty (CPP)
  5. Breast cancer (hormone receptor-positive) – off-label
  6. In-vitro fertilization (IVF) cycles – short-term use in ART
Storage Instructions:
  1. Store at 2°C–8°C (refrigerated)
  2. Protect from light and freezing
  3. Reconstitute just before use
  4. Keep out of reach of children
How It Works (Mechanism of Action):
Leuprolide acts as a GnRH agonist. After an initial stimulation of LH and FSH, continuous exposure leads to downregulation of pituitary GnRH receptors, resulting in decreased gonadotropin secretion. This leads to suppressed production of testosterone in males and estrogen in females, making it effective for hormone-dependent cancers and gynecological conditions.
Side Effects:
Common side effects:
  1. Hot flashes
  2. Headache
  3. Injection site pain
  4. Mood changes
  5. Fatigue
  6. Decreased libido
Serious side effects:
  1. Osteoporosis with long-term use
  2. Cardiovascular risks (especially in older males)
  3. Tumor flare (temporary symptom worsening)
  4. Depression or emotional instability
  5. Menstrual irregularities or amenorrhea (in women)
Dosage (Typical Recommended Dose):
  1. 11.25mg injection: Administered every 3 months
  2. 22.5mg injection: Administered every 6 months
  3. Dosing schedules may vary depending on the condition and treatment plan
Method of Administration:
  1. Administered intramuscularly (IM)
  2. To be given by a trained healthcare professional
  3. Reconstitute with provided diluent before injection
  4. Inject deep into the gluteal or thigh muscle
Precautions:
  1. Use caution in patients with cardiovascular disease, diabetes, or depression
  2. Monitor bone density in long-term therapy
  3. Not to be used in pregnancy or breastfeeding
  4. Inform patients about initial symptom flare, especially in prostate cancer
  5. Patients may require calcium and vitamin D supplementation
Drug Interactions:
  1. Can interact with hormone replacement therapy (HRT)
  2. May affect antidiabetic medications due to hormonal changes
  3. Caution with QT-prolonging drugs or antidepressants
Allergies:
  1. Contraindicated in individuals with known hypersensitivity to leuprolide or any of the formulation components
  2. Allergic reactions may include swelling, rash, breathing difficulty
Overdose Information:
  1. Overdose is rare due to depot formulation
  2. Symptoms may include hormone suppression effects
  3. Provide supportive and symptomatic treatment
Missed Dose Instructions:
  1. Administer the missed dose as soon as it is remembered
  2. Do not double the dose
  3. Resume the regular dosing schedule as directed by the physician
Additional Notes:
  1. Regular monitoring of hormone levels, PSA (in men), and clinical response is recommended
  2. In women of reproductive age, ensure contraception during therapy
  3. Educate patients on expected changes (e.g., menstruation stopping, sexual function changes)
  4. Monitor growth and development in children with long-term use

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