Active Ingredient: Urofollitropin
Urofollitropin is indicated for the treatment of female infertility in controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART) (e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)).
For this indication, competent medicine agencies globally authorize below treatments:
Subcutaneous
150 - 225 [iU]
From 150 To 225 [iU] once every day
In line with clinical trials with urofollitropin that involved down regulation with GnRH agonists, urofollitropin therapy should start approximately 2 weeks after the start of agonist treatment. The recommended initial dose of urofollitropin is 150-225 IU daily for at least the first 5 days of treatment. Based on clinical monitoring (including ovarian ultrasound alone or in combination with measurement of oestradiol levels) subsequent dosing should be adjusted according to individual patient response, and should not exceed 150 IU per adjustment. The maximum daily dose given should not be higher than 450 IU daily and in most cases dosing beyond 12 days is not recommended.
In protocols not involving down regulation, urofollitropin therapy should start on day 2 or 3 of the menstrual cycle. It is recommended to use the dose ranges and regimen of administration suggested above for protocols with down regulation with GnRH agonists.
When an optimal response is obtained a single injection of up to 10,000 IU hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. Patients should be followed closely for at least 2 weeks after hCG administration. If an excessive response to urofollitropin is obtained treatment should be stopped and hCG withheld, and the patient should use a barrier method of contraception or refrain from having coitus until the next menstrual bleeding has started.
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