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Ovidrel

Clinical Pharmacology
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Clinical Pharmacology

Ovidrel

Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection) has been determined to be bioequivalent to Ovidrel® (choriogonadotropin alfa for injection) based on the statistical evaluation of AUC and Cmax. A summary of the Ovidrel® PreFilled Syringe pharmacokinetic parameters is presented in Table 2.

Table 2 Summary of Ovidrel® PreFilled Syringe Pharmacokinetic Parameters


Parameter Cmax
(mIU/mL)		 AUClast
(mIU.h/mL)		 AUC
(mIU.h/mL)		 AUCextrapolated
(%)		 tmax
(h)
Mean
(Min - Max)		 125
(68.0 - 294)		 10050
(5646 - 14850)		 10350
(5800 - 15100)		 2.85
(1.08 - 6.27)		 20.0
(9.00 - 48.0)
Abbreviations are: Cmax: peak concentration (above baseline); tmax : time of Cmax

Special populations

Safety, efficacy, and pharmacokinetics of Ovidrel® PreFilled Syringe in patients with renal or hepatic insufficiency have not been established.

Drug-Drug Interactions

No drug-drug interaction studies have been conducted. Administration of Ovidrel® PreFilled Syringe may interfere with the interpretation of pregnancy tests. (see PRECAUTIONS)

Clinical Studies

The safety and efficacy of Ovidrel® have been examined in three well-controlled studies in women; two studies for assisted reproductive technologies (ART) and one study for ovulation induction (OI).

Assisted Reproductive Technologies (ART)s

The safety and efficacy of Ovidrel® 250 µg and Ovidrel® 500 µg administered subcutaneously versus 10,000 USP Units of an approved urinary-derived hCG product administered intramuscularly were assessed in a randomized, open-label, multicenter study in infertile women undergoing in vitro fertilization and embryo transfer (Study 7927). The study was conducted in 20 U.S. centers.

The primary efficacy parameter in this single-cycle study was the number of oocytes retrieved. 297 patients entered the study, of whom 94 were randomized to receive Ovidrel® 250 µg. The number of oocytes retrieved was similar for the Ovidrel® and urinary-derived hCG (10,000 USP Units) treatment groups. The efficacy of Ovidrel® 250 µg and Ovidrel® 500 µg were both found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product and to each other. The efficacy results for the patients who received Ovidrel® 250 µg are summarized in Table 3.

Table 3: Efficacy Outcomes of r-hCG in ART (Study 7927)


Parameter Ovidrel® 250 µg
(n = 94)
Mean number of oocytes retrieved per patient 13.60
Mean number of mature oocytes retrieved per patient 7.6
Mean number of 2 PN fertilized oocytes per patient 7.2
Mean number of 2 PN or cleaved embryos per patient 7.6
Implantation rate per embryo transferred (%) 18.7
Mean mid-luteal serum progesterone levels (nmol/L*) 423
Clinical pregnancy rate per initiated treatment cycle (%)† 35.1
Clinical pregnancy rate per transfer (%)† 36.3
†Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration)
*nmol/L ÷ 3.18 = ng/mL
Brand Name: Ovidrel
Generic Name: Choriogonadotropin Alfa Injection

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