Firma Chun Cheong
Concise Prescribing Info
Leuprorelin acetate
Treatment of hormone-dependent advanced prostate cancer & treatment of high-risk localized & locally advanced hormone-dependent prostate cancer in combination w/ radiotherapy.
Dosage/Direction for Use
22.5-mg SC inj Single inj every 3 mth. 45-mg SC inj Single inj every 6 mth.
Hypersensitivity to leuprorelin acetate, to other GnRH agonists, or to any of the excipients. Patients who previously underwent orchiectomy. As a sole treatment in prostate cancer patients w/ spinal cord compression or evidence of spinal metastases. Women. Childn.
Special Precautions
May prolong the QT interval. Reports of increased risk of developing MI, sudden cardiac death & stroke; decreased bone density; rare cases of pituitary apoplexy; hyperglycemia & DM; convulsions; cases of ureteral obstruction & spinal cord compression, which may contribute to paralysis w/ or w/o fatal complications. Transient increases in serum conc of testosterone, dihydrotestosterone & acid phosphatase during the 1st wk of treatment. Patients w/ vertebral &/or brain metastases as well as patients w/ urinary tract obstruction should be closely monitored during the 1st few wk of therapy. May affect ability to drive or operate machinery. Must be at room temp prior to inj. Remove from the refrigerator approx 30 min before use. Lack of clinical efficacy may occur due to incorrect reconstitution of the product.
Adverse Reactions
Hot flashes, nausea, malaise & fatigue, transient local irritation at inj site.
Drug Interactions
Increased risk of QT prolongation w/ medicinal products known to prolong the QT interval or able to induce Torsade de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics..
ATC Classification
L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Eligard powd for soln for inj 22.5 mg
(+ solvent) 1's
Eligard powd for soln for inj 45 mg
(+ solvent) 1's
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