Eligard

Eligard

leuprorelin

Manufacturer:

Tolmar

Distributor:

DCH Auriga
Concise Prescribing Info
Contents
Leuprorelin acetate
Indications/Uses
Palliative treatment of hormone-dependent advanced prostate cancer.
Dosage/Direction for Use
SC 7.5 mg Single dose every mth. 22.5 mg Single dose every 3 mth. 45 mg Single dose every 6 mth.
Contraindications
Hypersensitivity to leuprorelin acetate or to other GnRH agonists. Patients who previously underwent orchiectomy. Sole treatment in prostate cancer patients w/ spinal cord compression or evidence of spinal metastases. Women & childn.
Special Precautions
Instructions for reconstitution & administration must be strictly followed. Patients w/ history or risk factors for QT prolongation; receiving concomitant QT-prolonging medicinal products; assess benefit-risk ratio including the potential for Torsade de Pointes prior to initiating treatment. Correct electrolyte abnormalities; consider periodic monitoring of ECG & electrolytes. Increased risk of developing MI, sudden cardiac death & stroke; monitor for signs & symptoms of CV disease. Transient increase in serum conc of testosterone, dihydrotestosterone & acid phosphatase during the 1st wk of treatment. Consider additional administration of an appropriate antiandrogen 3 days prior to treatment & continuing for the 1st 2-3 wk of treatment, to prevent sequelae of an initial rise in serum testosterone. Decreased bone density in men who had orchiectomy or those treated w/ GnRH agonist. Monitor for symptoms of pituitary apoplexy (eg, sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status & CV collapse). Hyperglycemia & increased risk of developing diabetes; periodically monitor blood glucose &/or HbA1c. Convulsions. Institute standard treatment if spinal cord compression or renal impairment develops. Closely monitor patients w/ vertebral &/or brain metastases as well as w/ urinary tract obstruction. May impair ability to drive or operate machines due to fatigue, dizziness & visual disturbances. Pregnancy & lactation. Childn 0-18 yr.
Adverse Reactions
Hot flashes; ecchymoses, erythema; fatigue, inj site burning & paraesthesia. Nasopharyngitis; nausea, diarrhoea, gastroenteritis/colitis; pruritus, night sweats; arthralgia, limb pain, myalgia, rigors, weakness; urinary infrequency, micturition difficulty, dysuria, nocturia, oliguria; breast tenderness, testicular atrophy & pain, infertility, breast hypertrophy, erectile dysfunction, reduced penis size; malaise, inj site pain, bruising & stinging; hematology changes, anemia; increased blood creatinine phosphokinase, prolonged coagulation time.
Drug Interactions
Concomitant use w/ known QT-prolonging medicinal products able to induce Torsade de Pointes eg, class IA (eg, quinidine, disopyramide procainamide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Presentation/Packing
Form
Eligard powd for inj 22.5 mg
Packing/Price
(+ solvent) 1's
Form
Eligard powd for inj 45 mg
Packing/Price
(+ solvent) 1's
Form
Eligard powd for inj 7.5 mg
Packing/Price
(+ solvent) 1's
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