Cetrotide® blocks the effects of gonadotropin-releasing hormone (GnRH). GnRH controls the secretion of another hormone, luteinizing hormone (LH), which induces ovulation during the menstrual cycle.
During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrotide® blocks such undesirable premature ovulation.
In a phase III active-comparator-controlled clinical study of Cetrotide®, 115 patients received Cetrotide® 3 mg in a single dose and 159 received Cetrotide® 0.25 mg multidose. No patients (0%) receiving the 3 mg single dose, and 1% of patients receiving the 0.25 mg multidose experienced LH-surge (LH ≥10 U/L and Progesterone ≥1 ng/mL).
In a phase III Cetrotide®-only study, 303 patients received Cetrotide® 0.25 mg multidose and 1.0% experienced LH surge.
Adverse Events in ≥1% (WHO Preferred Term)
|Centrotide® N=949 % (n)|
|Ovarian Hyperstimulation Syndrome*||3.5 (33)|
*Intensity moderate or severe, or WHO Grade II or III, respectively.
Indications and Usage
Cetrotide® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. Cetrotide® should be prescribed by physicians who are experienced in fertility treatment.
IMPORTANT RISK INFORMATION
Cetrotide® is contraindicated in women who exhibit hypersensitivity to cetrorelix acetate, mannitol or medicines similar to Cetrotide®, who exhibit prior hypersensitivity to GnRH or any other GnRH analogs, or who are pregnant, are breast-feeding or have severe kidney disease.
WARNINGS AND PRECAUTIONS
Ovarian Hyperstimulation Syndrome (OHSS), with or without blood vessel or lung problems, can occur with the use of fertility drugs.
Mid and short lasting injection reactions like reddening, itching and swelling at the injection sites may occur. Nausea and headache have also been reported.
Please click here for Full Prescribing information for Cetrotide®.