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

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

leuprorelin

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Leuprorelin acetate
Indications/Uses
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 (negative hormone receptor expression); prostate cancer; central precocious puberty. Enantone 3-Month DPS 11.25 mg Male: Prostate cancer & its secondarisms. Female: Endometriosis w/ genital & extra-genital localization (Phase I-IV); breast cancer in pre & peri-menopausal women, where a hormone treatment is indicated; uterine fibroids. Childn: Precocious puberty (before 8 yr in females & before 10 yr in males). Enantone 6-Month DPS 30 mg Palliative treatment of advanced hormone-dependent prostate carcinoma.
Dosage/Direction for Use
Enantone 1-Month DPS 3.75 mg Endometriosis Adult 3.75 mg SC once every 4 wk. Patients w/ heavy wt or those w/ markedly enlarged uterus Administer 3.75 mg. Initiate administration on 1st-5th day after the start of the 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 <20 kg 5.63 mg once every 3 mth; ≥20 kg 11.25 mg once every 3 mth. Endometriosis & uterine fibroids 6 mth treatment duration. Enantone 6-Month DPS 30 mg SC once every 6 mth w/ interval of 168 days to max 182 days.
Contraindications
Enantone 1-Month DPS 3.75 mg Hypersensitivity to 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. In case of not diagnosed vag bleeding. Pregnancy & lactation. Enantone 6-Month DPS 30 mg Hypersensitivity to leuprorelin or other GnRH analogues, polylactic acid. Demonstrated non-hormone-dependent carcinoma. Pregnancy, lactation.
Special Precautions
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 treatment in case of growing phyma or no improvement is seen. Transient aggravation of clinical condition, bone pain. Depressed state-like climacteric disturbance. Perform LH-RH test at regular intervals. Enantone 3-Month DPS 11.25 mg Male: Transitory worsening of clinical symptomatology eg, bone pain, urinary tract obstruction & haematuria, weakness of the lower extremities & paresthesia due to temporary increase of serum testosterone level. Patients w/ neurological signs of spinal cord compression or in those w/ ureteric obstruction. Verify testosterone levels, PSA & acid phosphatase periodically. Female: Eventual onset of severe metrorrhagia; onset of serious vag bleeding during treatment. Use non-hormonal contraceptive methods during treatment. Fertile women. Verify periodically the values of bone densitometry in case of prolonged treatment. Temporary worsening of clinical status. Girls: May require additional adequate treatment if little genital hemorrhages after the 1st inj goes on beyond the 1st mth of treatment. Childn: Gonadotropin-pituitary inhibition. Check regularly that the estradiol/testosterone levels are low in case the wt is near 20 kilos. Increased risk of incident depression (which may be severe). Enantone 6-Month DPS 30 mg Monitor patients w/ HTN. Patients at risk of ureteric obstruction or spinal cord compression. Prostate cancer patients w/ vertebral metastasis. Increased risk of incident depression. Monitor potential neurological complications, spinal metastases, or urinary tract obstruction during the 1st few weeks of treatment. Increased risk of diabetes & certain cardiovascular diseases in men undergoing treatment of prostate cancer.
Adverse Reactions
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 Hot flushes. Male: Decrease of the libido, loss of bone mass, impotence, gynecomastia & reduction of testicular vol, testicular atrophy. Initial worsening of the urinary obstructive symptomatology (dysuria, haematuria, lumbar pain), of the muscoloskeletal symptomatology (bone pain), or of the neurological compression signs (weakness feeling, paresthesia of the lower extremities). Female: Libido reduction, menstrual disorders, vaginitis w/ hematic spotting, vag dryness, breast size decrease, arthralgia, myalgia. Girls: Occurrence of genital spots after the 1st inj.
Drug Interactions
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 & progesteron, mixed sex hormones.
ATC Classification
L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Presentation/Packing
Form
Enantone 1-Month DPS pre-filled syringe 3.75 mg
Packing/Price
1's
Form
Enantone 3-Month DPS pre-filled syringe 11.25 mg
Packing/Price
1's
Form
Enantone 6-Month DPS pre-filled syringe 30 mg
Packing/Price
1's
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