Intramuscular, Subcutaneous Female infertility of anovulatory origin
Adult: Anovulation (including polycystic ovarian syndrome) in women who are unresponsive to clomifene citrate: Begin treatment within the 1st 7 days of the menstrual cycle. Initially, 75-150 IU daily via IM or SC inj for at least 7 days. May increase dose if necessary, by 37.5 IU (up to 75 IU) at intervals of 7 or 14 days according to clinical monitoring and individual response. Max: 225 IU daily. Discontinue the cycle if patient fails to adequately respond after 4 weeks of treatment and may recommence at a higher initial dose. Alternatively, initiate at 150 IU once daily via IM or SC 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. Max treatment duration: 12 days. If an optimal response is obtained, administer 5,000-10,000 IU hCG as a single inj 24-48 hours 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. Dosage recommendations may vary among countries and individual products. Refer to local detailed product guidelines.
Intramuscular, Subcutaneous Controlled ovarian hyperstimulation for assisted reproduction in infertility
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 5,000-10,000 IU hCG as single inj 24-48 hours after the last urofollitropin dose. Further patient instructions and monitoring may be required based on individual ovarian response. Dosage recommendations may vary among countries and individual products. Refer to local detailed product guidelines.
Reconstitution
Reconstitute vial with 1 mL solvent (e.g. 0.9% NaCl) 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 total dosage of 450 IU (corresponding to 6 vials of urofollitropin 75 IU or 3 vials of urofollitropin 150 IU) may be dissolved with 1 mL of solvent.
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; ovarian cysts or enlargement not due to polycystic ovarian syndrome; ovarian, uterine, or mammary carcinoma. 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). Renal and hepatic impairment.
Adverse Reactions
Significant: Ovarian enlargement, ovarian hyperstimulation syndrome (OHSS), ovarian and other reproductive system neoplasms (benign and malignant), ovarian torsion; multiple pregnancy, spontaneous miscarriage, ectopic pregnancy, congenital malformations; serious pulmonary effects (e.g. atelectasis, acute respiratory distress syndrome, asthma exacerbation), thromboembolic events, hypersensitivity and anaphylactic reactions. Endocrine disorders: Hyperthyroidism. Gastrointestinal disorders: Abdominal pain or distension, nausea, dyspepsia, constipation. General disorders and admin site conditions: Pain, fatigue. Rarely, inj site reactions (e.g. pain, redness, haematoma). Investigations: Prolonged bleeding time. Nervous system disorders: Headache, lethargy, dizziness. Psychiatric disorders: Mood swings. Renal and urinary disorders: Cystitis. Reproductive system and breast disorders: Breast enlargement or pain. Respiratory, thoracic and mediastinal disorders: Epistaxis, dyspnoea. Skin and subcutaneous tissue disorders: Erythema, pruritus. Vascular disorders: Hot flushes.
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 transvaginal sonography of the ovaries and endometrial lining and measurement of estradiol levels. Monitor for signs and symptoms of OHSS (for at least 2 weeks after hCG administration) and thromboembolism.
Drug Interactions
May enhance the follicular response when given concomitantly with clomifene citrate.
Action
Description: Mechanism of Action: Urofollitropin, a gonadotrophin, is a highly purified preparation of FSH obtained from the urine of postmenopausal women. It stimulates ovarian follicular growth and development, and gonadal steroid production. Pharmacokinetics: Absorption: Bioavailability: Approx 70% (IM). 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).
Chemical Structure
Urofollitropin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 62819, Urofollitropin. https://pubchem.ncbi.nlm.nih.gov/compound/Urofollitropin. Accessed Feb. 23, 2022.
Storage
Store between 2-8°C or between 3-25°C. Protect from light. Storage recommendations may vary among individual products. Refer to detailed product guideline.
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 01/12/2021.Buckingham R (ed). Urofollitropin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/12/2021.Endogen HP Powder for Solution for (IM/SC) Injection (MedEthix Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 01/12/2021.Fostimon 75 IU, Powder and Solvent for Solution for Injection (IBSA Farmaceutici Italia S.r.l). MHRA. https://products.mhra.gov.uk. Accessed 01/12/2021.Joint Formulary Committee. Urofollitropin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/12/2021.
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