Product Introduction:
Luprova 22.5mg is an extended-release formulation of Leuprolide Acetate, a synthetic GnRH agonist used to manage hormone-sensitive conditions. It works by reducing the production of sex hormones (testosterone in men, estrogen in women) to help control disease progression. A single dose lasts for 6 months, improving patient compliance and convenience.
Uses:
Luprova 22.5mg is indicated for the treatment of:
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Advanced Prostate Cancer – testosterone suppression to control tumor growth
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Endometriosis – reduction of estrogen to manage symptoms and prevent tissue growth
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Uterine Fibroids – pre-surgical shrinkage or symptom relief
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Central Precocious Puberty (CPP) – delay premature puberty in children
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Hormone-sensitive Breast Cancer (in premenopausal women – off-label)
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In Vitro Fertilization (IVF) – ovarian suppression in assisted reproductive technologies
Storage Instructions:
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Store below 25°C (77°F)
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Protect from light and moisture
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Do not freeze
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Use the reconstituted solution immediately
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Keep out of the reach of children
How It Works (Mechanism of Action):
Leuprolide Acetate, as a GnRH agonist, initially stimulates the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to an initial rise in testosterone or estrogen levels. With continued use, it downregulates GnRH receptors in the pituitary gland, resulting in a dramatic reduction in LH and FSH secretion. This leads to a decrease in sex hormone levels, which helps control diseases like prostate cancer, endometriosis, and others.
Side Effects:
Common side effects include:
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Hot flashes
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Fatigue
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Sweating
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Headaches
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Decreased libido
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Mood changes
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Vaginal dryness (in women)
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Injection site pain or irritation
Serious side effects may include:
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Osteoporosis (bone thinning)
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Mood disorders (anxiety, depression)
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Elevated blood glucose or new-onset diabetes
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Prolonged QT interval (heart rhythm issues)
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Tumor flare (temporary worsening of symptoms at the start of treatment)
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Severe allergic reactions (rash, swelling, difficulty breathing)
Dosage (Typical Recommended Dose):
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22.5 mg intramuscular injection, administered once every 6 months (24 weeks)
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Dosage frequency and duration depend on the indication and patient’s response
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To be administered by a trained healthcare professional only
Method of Administration:
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Administered via deep intramuscular injection into the gluteal muscle
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Requires reconstitution with sterile diluent provided
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Injection must be performed by a qualified healthcare provider
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Do not self-administer
Precautions:
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Not to be used during pregnancy or breastfeeding
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Use non-hormonal birth control during treatment
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Monitor for bone loss, blood sugar levels, and emotional changes during therapy
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Caution in patients with heart disease, psychiatric conditions, or osteoporosis
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Tumor flare may occur in prostate cancer patients during initial therapy
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Ensure adequate calcium and vitamin D intake to prevent bone weakening
Drug Interactions:
Luprova 22.5mg may interact with:
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QT-prolonging drugs (e.g., amiodarone, fluoroquinolones)
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Diabetes medications (may affect blood sugar regulation)
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Corticosteroids (increase bone loss)
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Other hormonal treatments or chemotherapy
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Always inform your healthcare provider of all medications you are taking
Allergies:
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Contraindicated in patients allergic to Leuprolide Acetate, GnRH analogs, or any excipients in the product
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Be vigilant for signs of allergic reactions, including rash, swelling, difficulty breathing, and dizziness
Overdose Information:
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Overdose is uncommon, as the formulation is designed for controlled release
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Symptoms may include prolonged hormonal suppression, fatigue, or mood changes
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No specific antidote available; supportive care is necessary
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Seek immediate medical help in case of overdose
Missed Dose Instructions:
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If a dose is missed, consult your healthcare provider immediately
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Delayed dosing may result in hormonal rebound and worsening of disease
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Do not attempt to administer the dose yourself
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Always follow your doctor’s instructions regarding missed doses
Additional Notes:
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Periodic bone density monitoring (via DEXA scans) may be necessary for long-term use
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Patients should be monitored for PSA levels (for prostate cancer) or hormone levels as required
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Carry a medical alert card indicating use of hormone therapy
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Ensure regular check-ups for blood sugar levels, cholesterol, and mood stability
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Calcium and vitamin D supplements are recommended for bone health
