Urofollitropin is a hormone secreted from the gonadotropic cells of the anterior part of the pituitary gland. urofollitropin is a hormone-derived product containing very high purity FSH that is obtained from the urine of a postmenopausal woman and then LH is isolated from it.
Vial: Lyophilized, white to off-white sterile powder.
Ampoule: Sterile, colorless and free of particles
Powder: Mannitol, Disodium Hydrogen Phosphate, Sucrose, Phosphoric acid
Solvent: Sodium chloride 0.9%
Tips to be advised to the patient
- Urofollitropin has no effect on consciousness. Therefore, there is no limit to the ability to work with machinery and driving.
Tell your doctor or pharmacist if you have any side effects.
The effects of taking over the recommended amount of urofollitropin are unknown. However, it can cause excessive ovarian stimulation syndrome. If you take an extra dose randomly, contact your doctor or pharmacist for further advice.
If you forget to take a dose of medicine, contact your doctor as soon as you remember and avoid double the dose.
This medicine is prescribed for your current condition. So do not use it in similar cases or advice to others.
It is recommended that when using this drug, the name and serial number of the product is recorded in order to maintain the records of the used series.
Urofollitropin can be used only once after preparation. Discard the remainder of the medicine after taking.
- Long term treatment in pediatric patients showing growth retardation confirmed by inadequate secretion of the growth hormone.
- Long term treatment in pediatric patients showing growth retardation confirmed by renal insufficiency.
- Long term treatment in PWS pediatric patients.
- Long term treatment in Turner syndrome pediatric patients.
- Long term treatment in pediatric patients who were born smaller regarding their gestational age and who show growth retardation and lack of height recovery at two years of age.
- Wasting syndrome in AIDS patients.
- Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency.
- Idiopathic short stature.
Dosing and method of administration
Ovulation induction
Adults: Females: IM, SubQ: Initial: 150 units once daily for 5 days in the first cycle of treatment. After 5 days, dose adjustments up to 75-150 units can be made every ≥2 days based on ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels; maximum daily dose: 450 units; treatment >12 days is not recommended. If response to urofollitropin is appropriate, administer HCG; withhold the HCG dose if ovarian monitoring suggests an increased risk of OHSS and advise the patient to refrain from intercourse. For subsequent cycles, the starting dose and dosage adjustments should be determined based on historical ovarian response.
Assisted reproductive technologies (ART)
Adults: Females: SubQ: Starting on day 2 or 3 of cycle, administer 225 units once daily for the first 5 days; urofollitropin may be administered together with menotropins and the total initial dose of both products combined should not exceed 225 units (menotropins 150 units and urofollitropin 75 units; or menotropins 75 units and urofollitropin 150 units). Adjust dose after 5 days based on ultrasound monitoring of ovarian response and measurement of serum estradiol levels. Do not make additional adjustments more frequently than once every 2 days or by >75-150 units. Maximum daily dose: 450 units (of urofollitropin, or menotropins plus urofollitropin); treatment >12 days is not recommended; once adequate follicular development is evident, HCG should be administered. Withhold the HCG dose if ovarian monitoring suggests an increased risk of OHSS.
Use in renal and hepatic impairment
The safety and efficacy of this drug have not been established in patients with renal and hepatic failure.
Use in pediatric and elderly patients
The safety and efficacy of this drug have not been established in pediatric and elderly patients.