Fertinex^TM (urofollitropin for injection, purified) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Fertinex^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^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.

Pharmacokinetics

In a comparative, single-dose, double-blind, double-dummy, randomized, cross-over study, Fertinex^TM administered subcutaneously demonstrated a similar pharmacokinetic profile to urofollitropin and Fertinex^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^TM led to a slower absorption rate resulting in a later TMAX (15 ± 7h) than following IM administration of either Fertinex^TM (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^TM administered subcutaneously was found to be similar to that following urofollitropin and Fertinex^TM administered intramuscularly.

Special Populations

Safety and efficacy of Fertinex^TM in renal or hepatic insufficiency have not been established.

Drug-Drug Interactions

No clinically significant drug-drug interactions have been reported (see PRECAUTIONS).

CLINICAL STUDIES

Ovulation Induction

The safety and efficacy of Fertinex^TM 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^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 Fertinex^TM and 103 received urofollitropin. Overall, two-hundred and four patients (491 cycles) were considered evaluable. There were no differences between the Fertinex^TM 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^TM administered subcutaneously for ovulation induction in oligo-ovulatory infertile women are summarized below:

Cumulative Patient Ovulation Rates

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