Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: IM/SC Female infertility; Polycystic ovarian syndrome Begin treatment within the 1st 7 days of the menstrual cycle. Initial: 75 IU/day for at least 7 days, then adjust subsequent doses in increments of 37.5-75 IU per adjustment at intervals of at least 7 days according to clinical monitoring and individual response. Max: 225 IU/day. Discontinue the cycle if patient fails to adequately respond after 4 weeks of treatment. Alternatively, initiate at 150 IU once daily for 5 days, adjusted in increments of 75-150 IU per adjustment at intervals of at least 2 days according to clinical monitoring and individual response. Max: 450 IU/day. Assisted reproductive technologies; In vitro fertilisation procedures or other assisted conception techniques As monotherapy or in combination with GnRH agonist: Begin treatment on the 2nd or 3rd day of the menstrual cycle (without GnRH agonist down regulation), or approx 14 days after starting GnRH agonist treatment. Initial: 150-225 IU/day for at least 5 days, then adjust subsequent doses in increments of up to 150 IU/adjustment according to clinical monitoring and individual response. Max: 450 IU/day. Max treatment duration: 12 days. Dose discontinuation, hCG administration, and further patient instructions and monitoring may be required according to individual ovarian response (refer to detailed product guideline).
Primary ovarian failure, tumours of the pituitary gland or hypothalamus, abnormal uterine bleeding of undetermined origin, malformation of sexual organs or fibroid uterine tumours incompatible with pregnancy; sex hormone-dependent tumours of the reproductive tract and accessory organs; ovarian cysts or enlargement not due to polycystic ovarian syndrome; ovarian, uterine, or mammary carcinoma; uncontrolled nongonadal endocrinopathies (e.g. thyroid, adrenal, or pituitary disorders). Pregnancy and lactation.
Special Precautions
Women with recognised risk factors for thromboembolic events (e.g. personal or family history of thrombosis, severe obesity with BMI >30 kg/m2, thrombophilia); history of tubal disease. Renal and hepatic impairment. Patient Counselling This drug may increase risks of multiple or ectopic pregnancy, congenital malformations and spontaneous abortion. Your doctor needs to monitor your condition regularly. Monitoring Parameters Evaluate patient for infertility, hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, and pituitary or hypothalamic tumours before treatment initiation. Monitor sufficient follicular growth and maturation estimated directly by ovarian ultrasonography and serum oestradiol determination, and indirectly by oestrogenic activity evaluation (e.g. changes in vaginal cytology, appearance, or volume of cervical mucus) prior to and during treatment. Obtain direct and indirect indices of progesterone production (e.g. increased serum or urine LH, basal body temperature and serum progesterone) and sonographic evidence (e.g. collapsed follicle, fluid in cul-de-sac, features consistent with corpus luteum formation, secretory endometrium) to confirm ovulation. Monitor for signs and symptoms of thromboembolism and OHSS for at least 2 weeks after hCG administration.
Adverse Reactions
Significant: Ovarian enlargement, ovarian hyperstimulation syndrome (OHSS), benign and malignant ovarian neoplasms, ovarian torsion. Gastrointestinal disorders: Abdominal pain or distension, nausea, vomiting, diarrhoea, constipation, abdominal discomfort. General disorders and administration site conditions: Pain, fatigue, inj site reactions (e.g. pain, redness, bruising, swelling, itching). Metabolism and nutrition disorders: Dehydration, weight gain. Musculoskeletal and connective tissue disorders: Muscle spasms. Nervous system disorders: Headache, lethargy, dizziness. Psychiatric disorders: Depression, emotional lability. Renal and urinary disorders: UTI. Reproductive system and breast disorders: Pelvic pain, breast tenderness, vaginal haemorrhage or discharge. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, sinusitis. Skin and subcutaneous tissue disorders: Rash. Vascular disorders: Hot flushes, hypertension.
Potentially Fatal: Rarely, serious pulmonary effects (e.g. atelectasis, acute respiratory distress syndrome, asthma exacerbation), thromboembolic events.
Drug Interactions
May enhance the follicular response when given concomitantly with clomifene citrate.
ATC Classification
G03GA04 - urofollitropin ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Disclaimer: This information is independently developed by CIMS based on urofollitropin 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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