Cetrorelix Product Information | Cetrorelix Acetate for Injection

Product Details

Now Available as a Generic

AP-Rated and Bioequivalent to Cetrotide^®

Lower Cost Alternative

How Supplied

One Glass Vial Containing 0.26 – 0.27 mg Cetrorelix Acetate (corresponding to 0.25 mg cetrorelix), One Pre-filled Glass Syringe with 1 mL of Sterile Water for Injection, USP (pH 5-8), One 20 Gauge Needle (yellow) and One 27 Gauge Needle (grey).

NDC: 17478-793-12	UNIT OF SALE: 1
ORANGE BOOK: AP	TYPE: Rx
COMPARE TO: Cetrotide^®

Storage

Store Cetrorelix Acetate for Injection 0.25 mg in the refrigerator at 2°C to 8°C (36°F to 46°F).

Keep the packaged tray in the outer carton in order to protect it from light.

Important Safety Information

INDICATIONS AND USAGE:
Cetrorelix Acetate for Injection 0.25 mg (Cetrorelix) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. Cetrorelix should be prescribed by physicians who are experienced in fertility treatment.

IMPORTANT RISK INFORMATION:
Contraindications
Cetrorelix is contraindicated in women who exhibit hypersensitivity to Cetrorelix, mannitol or medicines similar to Cetrorelix, 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.

Adverse Reactions
Mild 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.