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FertinexTM (urofollitropin for injection, purified) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Fertinex (urofollitropin) TM is the primary hormone responsible for follicular recruitment and development. In order to effect final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following the administration of Fertinex (urofollitropin) TM when monitoring of the patient indicates that sufficient follicular development has occurred. There may be a degree of interpatient variability in response to FSH administration.
In a comparative, single-dose, double-blind, double-dummy, randomized, cross-over study, Fertinex (urofollitropin) TM administered subcutaneously demonstrated a similar pharmacokinetic profile to urofollitropin and Fertinex (urofollitropin) TM administered intramuscularly. No significant differences were found between the treatment groups in AUC/dose and CMAX/dose parameters. A variability in TMAX was observed. Subcutaneous administration of Fertinex (urofollitropin) TM led to a slower absorption rate resulting in a later TMAX (15 ± 7h) than following IM administration of either FertinexTM (10 ± 4h) or urofollitropin (9 ± 4h).
Plasma inhibin levels were measured as a pharmacodynamic marker of FSH activity. The inhibin concentration-time profile of inhibin following Fertinex (urofollitropin) TM administered subcutaneously was found to be similar to that following urofollitropin and Fertinex (urofollitropin) TM administered intramuscularly.
No clinically significant drug-drug interactions have been reported (see PRECAUTIONS).
The safety and efficacy of FertinexTM administered subcutaneously vs. urofollitropin administered intramuscularly for ovulation induction was assessed in a phase III, open-label, randomized, comparative, multicenter study in oligo-ovulatory infertile women who failed to ovulate or conceive following adequate clomiphene citrate therapy. The purpose of the study was to demonstrate that Fertinex (urofollitropin) TM a highly purified follicle stimulating hormone (FSH) administered subcutaneously, is clinically not different in terms of safety and efficacy from urofollitropin administered intramuscularly. The principal efficacy parameters recorded were serum estradiol levels, follicular growth, ovulation rate and pregnancy rate. Two hundred eleven patients entered treatment, of whom 108 received FertinexTM and 103 received urofollitropin. Overall, two-hundred and four patients (491 cycles) were considered evaluable. There were no differences between the FertinexTM administered subcutaneously and the urofollitropin intramuscular treatment groups in serum estradiol levels and follicular growth (follicle number and size) on the day of human chorionic gonadotropin (hCG) administration, nor were there any differences between the treatment groups in ovulation rates or pregnancy rates per patient.
The results of safety and efficacy with Fertinex (urofollitropin) TM administered subcutaneously for ovulation induction in oligo-ovulatory infertile women are summarized below:
Cumulative Patient Ovulation Rates
The cumulative patient ovulation rate by cycle is presented for the 102 evaluable patients with documentation of ovulatory status in at least one cycle :
Cumulative Patient Pregnancy Rates
The cumulative patient pregnancy rate by cycle is presented for 86 evaluable patients who received hCG :
|Severe Hyperstimulation Syndrome||0%|
* Based upon 25 evaluable clinical pregnancies
** Based upon 108 patients and 266 cycles evaluable for safety
Assisted Reproductive Technologies (ART)
The safety and efficacy of Fertinex (urofollitropin) TM administered subcutaneously for Assisted Reproductive Technologies (ART) were assessed in a phase III, multicenter, non-comparative, clinical trial in ovulatory infertile women undergoing stimulation of multiple follicular development for In Vitro Fertilization and Embryo Transfer (IVF/ET) after pituitary down-regulation with a GnRH agonist. The initial and maximal doses of Fertinex (urofollitropin) TM were 225 and 450 IU, respectively, The principal parameters recorded were serum estradiol on day of hCG administration, the number and maturity of retrieved oocytes, drug therapy and duration, and clinical pregnancy rate per initiated cycle and per retrieval. One hundred and thirty-nine patients were enrolled in the study; 135 patients were treated with Fertinex (urofollitropin) TM and 122 patients were considered evaluable for efficacy. The results listed below represent mean data of 118 evaluable patients who received hCG in the 10 study centers:
|Total number of oocytes recovered||8.4|
|Mature oocytes recovered||5.9|
|Maximum serum E2, day hCG (pg/mL)||1682|
|Total number of ampules (75 IU)||36|
|Treatment duration (days)||11.5|
|Clinical pregnancy attempt|| |
|Clinical pregnancy transfer|| |
* reflects range across centers
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Fertinex Information
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