Generic Medicine Info
Pregnancy, lactation; hypersensitivity to GnRH, GnRH agonist analogs or product excipients; undiagnosed abnormal vaginal bleeding.
Special Precautions
Vary inj site periodically. May cause transient elevation of testosterone levels during the first 1-2 wk, which may lead to worsening or onset of new symptoms (e.g. bone pain, neuropathy, haematuria) in prostate cancer patients. Ureteral obstruction and spinal cord compression have been reported; closely monitor patients with urinary obstruction and/or metastatic vertebral lesion. Leuprorelin is associated with increased risk of diabetes and certain CV diseases (heart attack, sudden cardiac death, stroke) when used in men for treatment of prostate cancer. For prostate cancer, monitor response by testosterone and prostate-specific antigen (PSA) levels. For precocious puberty in children, monitor response by GnRH stimulation test sex steroid levels 1-2 month after treatment initiation. Leuprorelin usually inhibits ovulation and stops menstruation in women, but does not incur contraception, non-hormonal contraception should be used as pregnancy is contraindicated. May cause adverse reactions associated with hypoestrogenism and loss in bone density.
Adverse Reactions
Inj site reactions. Treatment of precocious puberty: General pain, headache, acne, rash, seborrhoea, emotional lability, vaginitis, vaginal bleeding vaginal discharge. Treatment of prostate cancer: Transient worsening of signs and symptoms (usually increase in bone pain), ECG changes, high blood pressure, peripheral oedema, anorexia, constipation, nausea, vomiting, anaemia, myalgia, dizziness, general pain, headache, insomnia or sleep disorder, sinus congestion, urinary frequency/urgency, haematuria, UTI, asthaenia, physiological effects of decreased testosterone (e.g. gynaecomastia, breast tenderness, decreased testicular size, hot flashes, impotence). Treatment of endometriosis and uterine fibroids treatment: General pain, headache, asthaenia, nausea, vomiting, oedema, weight changes, acne, hirsutism, dizziness, insomnia, sleep disturbance, paraesthesias, skin reactions, effects of hypoestrogenism such as hot flashes, joint disorder, myalgia, decreased libido, depression, emotional lability, nervousness, breast tenderness, vaginitis.
Potentially Fatal: Anaphylactic reactions.
ATC Classification
L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Disclaimer: This information is independently developed by CIMS based on leuprorelin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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