Urofollitropin


Full Generic Medicine Info
Dosage/Direction for Use

Parenteral
Polycystic ovarian syndrome
Adult: For induction of ovulation in women who are unresponsive to clomifene citrate or has previously received pituitary suppression: Begin treatment within the 1st 7 days of the menstrual cycle. Initially, 75 IU daily via IM or SC inj for at least 7 days, then adjusted in increments of at least 37.5 IU up to 75 IU at intervals of at least 7 days according to clinical monitoring and individual response. Max: 225 IU daily. Discontinue if patient fails to adequately respond after 4 weeks of treatment. Alternatively, initiate at 150 IU once daily via SC or IM inj for 5 days, adjusted in increments of 75-150 IU at intervals of at least 2 days according to response. Max: 450 IU daily. If an optimal response is obtained, administer 5,000-1,000 IU hCG as a single inj 1 day after the last urofollitropin dose. If an excessive response is obtained, discontinue treatment and withhold hCG administration. Further instructions and monitoring may be required based on individual response.
Reconstitution: Reconstitute a vial with 1 mL 0.9% NaCl solvent provided then gently swirl or roll the vial to dissolve the powder until the solution becomes clear. Do not shake the vial. If >1 vial is necessary for a single dose, withdraw the entire contents of the 1st reconstituted solution and use it as the diluent for the 2nd powder vial until the prescribed dose is reached. Max of 6 powder vials (450 IU) may be dissolved with 1 ampoule of solvent. After reconstitution, solution may be mixed with menotrophin inj prior to administration.

Parenteral
Female infertility
Adult: For induction of ovulation in women who are unresponsive to clomifene citrate or has previously received pituitary suppression: Begin treatment within the 1st 7 days of the menstrual cycle. Initially, 75 IU daily via IM or SC inj for at least 7 days, then adjusted in increments of at least 37.5 IU up to 75 IU at intervals of at least 7 days according to clinical monitoring and individual response. Max: 225 IU daily. Discontinue if patient fails to adequately respond after 4 weeks of treatment. Alternatively, initiate at 150 IU once daily via SC or IM inj for 5 days, adjusted in increments of 75-150 IU at intervals of at least 2 days according to response. Max: 450 IU daily. If an optimal response is obtained, administer 5,000-1,000 IU hCG as a single inj 1 day after the last urofollitropin dose. If an excessive response is obtained, discontinue treatment and withhold hCG administration. Further instructions and monitoring may be required based on individual response.
Reconstitution: Reconstitute a vial with 1 mL 0.9% NaCl solvent provided then gently swirl or roll the vial to dissolve the powder until the solution becomes clear. Do not shake the vial. If >1 vial is necessary for a single dose, withdraw the entire contents of the 1st reconstituted solution and use it as the diluent for the 2nd powder vial until the prescribed dose is reached. Max of 6 powder vials (450 IU) may be dissolved with 1 ampoule of solvent. After reconstitution, solution may be mixed with menotrophin inj prior to administration.

Parenteral
In vitro fertilisation procedures or other assisted conception techniques
Adult: As monotherapy or in combination with gonadotropin-releasing hormone (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. Initially, 150-225 IU daily via IM or SC inj for at least 5 days. Subsequent doses should be adjusted in increments of up to 150 IU per adjustment according to clinical monitoring (e.g. ovarian ultrasound, measurement of serum oestradiol levels) and individual response. Max: 450 IU daily. Recommended Max treatment duration: 12 days. If an optimal response is obtained, administer 10,000 IU hCG as single inj to induce final follicular maturation in preparation for oocyte retrieval. If an excessive response is obtained, discontinue treatment and withhold hCG administration. Further patient instructions and monitoring may be required based on individual ovarian response (refer to detailed product guideline).
Reconstitution: Reconstitute a vial with 1 mL 0.9% NaCl solvent provided then gently swirl or roll the vial to dissolve the powder until the solution becomes clear. Do not shake the vial. If >1 vial is necessary for a single dose, withdraw the entire contents of the 1st reconstituted solution and use it as the diluent for the 2nd powder vial until the prescribed dose is reached. Max of 6 powder vials (450 IU) may be dissolved with 1 ampoule of solvent. After reconstitution, solution may be mixed with menotrophin inj prior to administration.

Parenteral
Assisted reproductive technologies
Adult: As monotherapy or in combination with gonadotropin-releasing hormone (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. Initially, 150-225 IU daily via IM or SC inj for at least 5 days. Subsequent doses should be adjusted in increments of up to 150 IU per adjustment according to clinical monitoring (e.g. ovarian ultrasound, measurement of serum oestradiol levels) and individual response. Max: 450 IU daily. Recommended Max treatment duration: 12 days. If an optimal response is obtained, administer 10,000 IU hCG as single inj to induce final follicular maturation in preparation for oocyte retrieval. If an excessive response is obtained, discontinue treatment and withhold hCG administration. Further patient instructions and monitoring may be required based on individual ovarian response (refer to detailed product guideline).
Reconstitution: Reconstitute a vial with 1 mL 0.9% NaCl solvent provided then gently swirl or roll the vial to dissolve the powder until the solution becomes clear. Do not shake the vial. If >1 vial is necessary for a single dose, withdraw the entire contents of the 1st reconstituted solution and use it as the diluent for the 2nd powder vial until the prescribed dose is reached. Max of 6 powder vials (450 IU) may be dissolved with 1 ampoule of solvent. After reconstitution, solution may be mixed with menotrophin inj prior to administration.
Contraindications
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.
Action
Urofollitropin is a highly purified preparation of FSH extracted from the urine of postmenopausal women. It stimulates ovarian follicular growth and development, and gonadal steroid production in women without primary ovarian failure.
Absorption: Time to peak plasma concentration: IM: 17 hours (single dose); 11 hours (multiple doses). SC: 21 hours (single dose); 10 hours (multiple doses).
Excretion: Elimination half-life: IM: 37 hours (single dose); 15 hours (multiple doses). SC: 32 hours (single dose); 21 hours (multiple doses).
Storage
Parenteral: Store between 3-25°C. Do not freeze. Protect from light. Follow applicable procedures for receiving, handling, administration, and disposal.
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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