Enantone L.P.

Enantone L.P.

leuprorelin

Manufacturer:

Takeda

Distributor:

DKSH
Concise Prescribing Info
Contents
Leuprorelin acetate
Indications/Uses
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 radiotherapy 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).
Dosage/Direction for Use
Endometriosis One 3.75-mg inj SC/IM mthly or one 11.25-mg inj SC/IM every 3 mth. Start during the first 5 days of menstrual cycle. Patients 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. Patients 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 first 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 first 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.
Contraindications
Hypersensitivity to leuprorelin acetate, GnRH or GnRH analogues. Undiagnosed abnormal vag bleeding. Pregnancy & lactation.
Special Precautions
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 first 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.
Adverse Reactions
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 liver function test; alopecia, hyperhydrosis; arthralgia, myalgia; breast atrophy, vulvovaginal 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.
Drug Interactions
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 Prolonged QT interval w/ drugs that are known to prolong QT interval or induce Torsades de pointes eg, Class IA (eg, quinidine, disopyramide) or Class III (eg, amiodarone, sotalol, dofetilide, ibutilide), antiarrhythmic drugs, methadone, moxifloxacin, antipsychotics.
ATC Classification
L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Presentation/Packing
Form
Enantone L.P. powd for inj 3.75 mg
Packing/Price
(dual chamber) 1's
Form
Enantone L.P. powd for inj 11.25 mg
Packing/Price
(dual chamber) 1's
Form
Enantone L.P. powd for inj 1.88 mg
Packing/Price
(dual chamber) 1's
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