Urofollitropin


Concise Prescribing Info
Indications/Uses
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).
Dosage Details
Intramuscular, Subcutaneous
Female infertility, 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. Subsequent doses should be adjusted in increments of at least 37.5 IU up to 75 IU per adjustment at intervals of at least 7 days according to clinical monitoring (e.g. ovarian ultrasound, measurement of serum oestradiol levels) and individual response. Max: 225 IU daily. Discontinue the cycle 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 per adjustment at intervals of at least 2 days according to clinical monitoring and individual 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 patient instructions and monitoring may be required based on individual ovarian response (refer to detailed product guideline).

Intramuscular, Subcutaneous
Assisted reproductive technologies, 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.
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.
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 admin 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.
Reproductive system and breast disorders: Pelvic pain, breast tenderness, vaginal haemorrhage or discharge.
Renal and urinary disorders: UTI.
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.
IM/Parenteral/SC: X
Patient Counseling Information
This drug may increase risks of multiple or ectopic pregnancy, congenital malformations and spontaneous abortion. Your doctor needs to monitor your condition regularly.
MonitoringParameters
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.
Drug Interactions
May enhance the follicular response when given concomitantly with clomifene citrate.
Action
Description: 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.
Pharmacokinetics:
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
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.
References
Anon. Urofollitropin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 03/09/2019.

Bravelle (Ferring Pharmaceutical Inc). U.S. FDA. https://www.fda.gov/. Accessed 03/09/2019.

Bravelle 75 IU Powder and Solvent for Solution for Injection (Ferring Pharmaceutical Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 03/09/2019.

Buckingham R (ed). Urofollitropin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/09/2019.

Fostimon PFS 150 IU Powder and Solvent for Solution for Injection (IBSA Farmaceutici Italia). MHRA. https://products.mhra.gov.uk/. Accessed 03/09/2019.

Joint Formulary Committee. Urofollitropin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 03/09/2019.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in