Enantone 1-Month DPS 3.75 mg/Enantone 3-Month DPS 11.25 mg/Enantone 6-Month DPS 30 mg

Leuprorelin acetate

Enantone 1-Month DPS 3.75 mg Endometriosis. Decrease of myoma vol &/or amelioration of symptoms in uterine myoma w/ hypermenorrhea, hypogastralgia, low back pain, anemia, etc (conservative treatment). Premenopausal breast cancer (+ve hormone receptor expression). Prostate cancer. Central precocious puberty. Enantone 3-Month DPS 11.25 mg Male: Prostate cancer & its secondarisms. Female: Genital & extragenital endometriosis (Phase I-IV). Breast cancer in pre- & peri-menopausal women, where a hormone treatment is indicated. Uterine fibroids. Childn: Central precocious puberty (before 9 yr in girls & before 10 yr in boys). Enantone 6-Month DPS 30 mg Advanced hormone-dependent prostate carcinoma in adult males: Locally advanced hormone-dependent prostate cancer during & following RT. Localized hormone-dependent prostate cancer in patients w/ intermediate & high risk in combination w/ RT.

Enantone 1-Month DPS 3.75 mg Endometriosis Adult 3.75 mg SC once every 4 wk. Patient weighing <50 kg 1.88 mg. Uterine myoma Adult 1.88 mg SC once every 4 wk. Patient w/ heavy wt or w/ markedly enlarged uterus 3.75 mg. Initiate administration on the 1st-5th day after start of menstrual period. Prostate cancer & premenopausal breast cancer Adult 3.75 mg SC once every 4 wk. Central precocious puberty 30 mcg/kg SC once every 4 wk, may be increased up to 180 mcg/kg. Enantone 3-Month DPS 11.25 mg Male & female 11.25 mg once every 3 mth. Childn weighing ≥20 kg 11.25 mg once every 3 mth, <20 kg 5.63 mg once every 3 mth. Endometriosis & uterine fibroids Up to 6 mth treatment duration. Enantone 6-Month DPS 30 mg Administer SC once every 6 mth w/ interval of 168 days to max 182 days.

Enantone 1-Month DPS 3.75 mg Hypersensitivity to leuprorelin acetate or synthetic LH-RH or LH-RH derivatives. Abnormal genital bleeding of indeterminable nature. Women having possibilities of being pregnant. Pregnancy & lactation. Enantone 3-Month DPS 11.25 mg Hypersensitivity to leuprorelin acetate or to any other synthetic GnRH analogues or derivatives. Presence of undiagnosed vag bleeding. Pregnancy & lactation. Enantone 6-Month DPS 30 mg Hypersensitivity to leuprorelin or other synthetic GnRH analogues or polylactic acid. Demonstrated non-hormone-dependent carcinoma. Pregnancy & lactation.

Enantone 1-Month DPS 3.75 mg Patients w/ submucous myoma; renal dysfunction due to spinal cord compression or ureteral obstruction or those who may be at a risk of developing such manifestations. Discontinue administration in case of any growing phyma, any progression of tumor, or no improvement in clinical symptom. Transient aggravation of clinical condition; transient aggravation of bone pain; ureteral obstruction or spinal cord compression; depressed state-like climacteric disturbance. Perform LH-RH test at regular intervals during treatment. Use for premenopausal breast cancer & prostate cancer should be limited to patients for whom treatment is considered appropriate. Safety in prematures, newborns & nursing infants has not been established. Enantone 3-Month DPS 11.25 mg May be associated w/ metabolic changes (eg, reduction of glucose tolerance or worsening of pre-existing diabetes) as well as increased risk of CV diseases. Androgen deprivation therapy may lead to QT interval prolongation. Reports of seizures in both childn & adults, w/ or w/o history of epilepsy, seizure disorders, or risk factors for seizures; idiopathic intracranial HTN (pseudotumor cerebri). Increased risk of incident depression. May affect ability to drive or operate machinery. Males: Transitory worsening of clinical symptomatology eg, urinary tract obstruction & haematuria following a temporary increase in testosterone levels. Bone pain, weakness of lower extremities & transitory paresthesia in patients w/ spinal cord compression due to spinal cord metastasis. Periodically check for testosteronaemia, PSA & acid phosphatase. Risk of hypoandrogenism, inducing reduction of bone mineral density. Increased risk of onset of MI, sudden cardiac death & stroke. Females: Severe metrorrhagia during treatment. Women of childbearing potential must use non-hormonal contraception during treatment & until menstrual cycle is resumed. Risk of hypoestrogenism, causing reduction of bone mineral density. Paed population: Small amounts of genital bleeding after 1st inj in girls. Regularly check that oestradiol/testosterone levels remain low, especially if wt is approaching 20 kg. Caution in patients w/ progressive brain tumours. Decreased bone mineral density during therapy. Slippage of femoral epiphysis after stopping treatment. Enantone 6-Month DPS 30 mg Avoid accidental intra-arterial inj. Closely monitor patients w/ HTN. Increased risk of incident depression. Treatment does not lead to further reduction of testosterone levels after surgical castration. Patients w/ potential neurological complications, spinal metastases, or urinary tract obstruction should be monitored closely during the 1st few wk of treatment. Regularly monitor treatment success through clinical exam & investigations of phosphates, PSA, as well as serum testosterone. Long-term therapy is associated w/ increased risk of bone demineralisation. May lead to osteoporosis & increased risk for bone fracture in patients w/ high risk. Reduction in glucose tolerance or aggravation of pre-existing DM, & increased risk for CV diseases. Monitor diabetic patients & patients w/ increased risk of metabolic or CV disorders. May prolong QT interval. Caution in patients w/ history of or risk factors for QT prolongation & those receiving concomitant medicinal products that might prolong the QT interval. Reports of seizures in childn & adults w/ or w/o history of epilepsy, seizures or risk factors for seizures. Can lead to +ve results in doping tests. Consider treatment discontinuation in case of idiopathic intracranial HTN (pseudotumor cerebri). May impair ability to drive or operate machinery, especially in combination w/ alcohol. No data available for use in childn. Not intended for use in women.

Enantone 1-Month DPS 3.75 mg Hot flushes, feeling of warmth, feeling of hot flushes, shoulder stiffness, headache, insomnia, dizziness, or diaphoresis; pains eg, arthralgia & bone pain. Enantone 3-Month DPS 11.25 mg All patients: Depression, mood changes (long-term use). Adult patients: Hot flashes. Arthralgia; oedema. Adult women: Headache (occasionally severe). Dizziness, paraesthesia; breast tenderness; inj site reaction. Adult men: Wt gain; drowsiness; hyperhidrosis; muscle weakness; erectile dysfunction, testicular atrophy, decreased libido; inj site reaction, fatigue. Decreased appetite; insomnia; headache (occasionally severe); nausea, constipation; abnormal liver function (including jaundice), abnormal LFTs (usually transient); gynecomastia. Paed patients: Emotional lability; headache; abdominal pain &/or cramps, nausea, vomiting; acne; vag bleeding &/or discharge; inj site reaction. Enantone 6-Month DPS 30 mg Hot flushes; hyperhidrosis; bone pain, muscular weakness; erectile dysfunction, decrease in or loss of libido & potency, reduced testicle size; inj site reactions (eg, erythema, pain, oedema, pruritus, abscesses, swelling, node & necrosis formation), increased sweating, tiredness; wt gain. Loss of appetite/increased appetite; depression, mood changes, sleep disturbances; headaches; nausea/vomiting; abnormal LFT; joint or back pain; gynaecomastia; nocturia, dysuria, pollakisuria; peripheral oedema, paraesthesia, sleep disturbances; elevations of LDH, transaminases, γ-glutamyl transferase & alkaline phosphatase.

Enantone 1-Month DPS 3.75 mg Reduced effect w/ sex hormone prep eg, estradiol derivatives, estriol derivatives, conjugated estrogen prep, combined prep of estrogen & progesterone, mixed sex hormones. Enantone 3-Month DPS 11.25 mg Additive effect on QT interval prolongation w/ medicinal products known to prolong QT interval or associated w/ torsades de pointes [eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics]. Enantone 6-Month DPS 30 mg Additive effect on QT interval 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) antiarrhythmics, methadone, moxifloxacin & antipsychotics.

Cancer Hormone Therapy / Trophic Hormones & Related Synthetic Drugs

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

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