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 Palliative treatment of advanced hormone-dependent prostate carcinoma.

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 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. Risk of hypogonadism under long-term therapy. Changes of glucose tolerance levels. +ve results in doping tests. Increased risk of diabetes & certain CV diseases (including heart attack, sudden cardiac death or stroke). May mildly or moderately impair ability to drive or operate machinery.

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; bone pain; decrease in or loss of libido & potency, reduction in testicle size; inj site reactions; increased sweating; wt gain. Loss of appetite; depression, mood changes; headache; nausea/vomiting; joint or back pain, muscle weakness; gynaecomastia; nocturia, dysuria, pollakiuria; tiredness, peripheral edema, 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].

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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