Enantone L.P.

Leuprorelin acetate

1.88-mg: Endometriosis; decrease of myoma vol &/or amelioration of symptoms in uterine myoma w/ hypermenorrhea, hypogastralgia, low back pain, anemia. 3.75-mg: Endometriosis at genital & extragenital localization (stage I-IV); uterine leiomyomata (fibroids), prostate cancer for metastatic prostate cancer; as an alternative to surgical castration for locally advanced prostate cancer; as an adjuvant treatment to radiotherapy in patients w/ high-risk localized or locally advanced prostate cancer; as an adjuvant treatment to radical prostatectomy in patients w/ locally advanced prostate cancer at high-risk of disease progression), central precocious puberty, premenopausal breast cancer. 11.25-mg: Prostate cancer for metastatic prostate cancer, as alternative to surgical castration for locally advanced prostate cancer; as adjuvant treatment to RT in patients w/ high-risk localized or locally advanced prostate cancer or to radical prostatectomy in patients w/ locally advanced prostate cancer at high-risk of disease progression); endometriosis at genital & extragenital localizations (stage I-IV), symptomatic uterine leiomyomata (fibroids), premenopausal breast cancer; central precocious puberty (girls <9 yr, boys <10 yr).

Endometriosis One 3.75-mg inj SC/IM mthly or one 11.25-mg inj SC/IM every 3 mth. Start during the 1st 5 days of menstrual cycle. Patient weighing <50 kg May be used 1.88 mg inj. Management of endometriosis including pain relief & reduction of endometriosis lesions Duration: 6 mth. 3.75-mg or 11.25-mg inj may be administered for a period of 12 mth w/ concurrent hormonal replacement therapy (norethindrone acetate 5 mg daily). Uterine leiomyomata (fibroids) One 1.88 mg inj SC/IM mthly. Patient w/ heavy wt or those w/ markedly enlarged uterus One 3.75 mg inj mthly or one 11.25 mg inj every 3 mth initiated on the 1st 5 days after the start of menstrual period. Duration (11.25 mg): 6 mth. Prostate cancer Adult (including elderly) One 3.75-mg SC/IM mthly or one 11.25 mg SC/IM every 3 mth. Premenopausal breast cancer Adult One 3.75-mg inj mthly. Start during the 1st 5 days of the menstrual cycle. Duration: 6 mth. Alternatively, one 11.25 mg inj SC/IM every 3 mth. Central precocious puberty 90-400 mcg/kg SC/IM mthly or one 11.25 mg SC/IM every 3 mth.

Hypersensitivity to leuprorelin acetate, GnRH or GnRH analogues. Undiagnosed abnormal vag bleeding. Pregnancy & lactation.

Frequently monitor blood glucose during treatment in diabetic patients. Seizure may occur. Patients w/ submucous myoma. Increased risk of bone loss; depression. May impair the ability to drive or operate machinery. 3.75-mg & 11.25-mg DPS: To reduce risk of flare, administer anti-androgen 3 days prior to therapy & continue for the 1st 2-3 wk of treatment. Prolonged use. Carefully consider & closely supervise patients at risk of ureteric obstruction or spinal cord compression in the 1st few wk of treatment. Monitor patients at high risk for metabolic or CV diseases. Childn w/ progressive brain tumours. Patients w/ history or risk factors for QT prolongation, & receiving drugs that may prolong QT interval. Chronic alcohol &/or tobacco use, strong family history of osteoporosis or chronic use of drug that can reduce bone mass eg, anticonvulsants or corticosteroid. 3.75-mg DPS: Male patients w/ urinary obstruction &/or metastatic verbal lesions should be supervised for the 1st few wk of treatment & may have incidences of flare up syndrome. 11.25-mg DPS: Long-term gonadotroprin deprivation. Idiopathic &/or neurogenic central precocious puberty diagnosis prior to start of therapy in girls.

Pituitary apoplexy. Hypersensitivity (including anaphylacyic reactions, rash & pruritus), wt fluctuation, decreased appetite; decreased libido, affect lability, depression; sleep disorder; headache, dizziness, paresthesia, pituitary haemorrhage, seizure; QT prolongation; visual impairment; hot flush; nausea, vomiting; abnormal LFT; alopecia, hyperhydrosis; arthralgia, myalgia; breast atrophy, vulvovag dryness, vulvovaginitis; inj site reaction, oedema. 1.88-mg: Intestinal pneumonia accompanied by fever, coughing, dyspnea, abnormal chest x-ray; jaundice; development or aggregation of DM. 3.75-mg & 11.25-mg: Bone pain, urinary tract obstruction, weakness of lower extremity, paresthesia.

1.88-mg DPS: May reduce effects w/ sex hormone prep (eg, estradiol & estriol derivatives, conjugated estrogen prep, combined prep of estrogen & progesterone, mixed sex hormones). 3.75-mg & 11.25-mg DPS: Drugs prolonging QT interval or inducing Torsades de Pointes eg, Class IA (eg, quinidine, disopyramide) or Class III (eg, amiodarone, sotalol, dofetilide, ibutilide), antiarrhythmic drugs, methadone, moxifloxacin, antipsychotics.

Trophic Hormones & Related Synthetic Drugs / Cancer Hormone Therapy

L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.

S