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(cetrorelix acetate) for Injection 0.25 mg and 3 mg
FOR SUBCUTANEOUS USE ONLY
Cetrotide® (cetrorelix acetate for injection) is a synthetic decapeptide with gonadotropin- releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is an analog of native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and 10. The molecular formula is Acetyl-D-3-(2´-naphtyl)-alanine-D-4-chlorophenylalanine-D-3-(3´-pyridyl)- alanine-L-serine-L-tyrosine-D-citruline-L-leucine-L-arginine-L-proline-D-alanine-amide, and the molecular weight is 1431.06, calculated as the anhydrous free base. The structural formula is as follows:
(Ac-0-Nal 1 -D-Cpa2-D-Pal3-Ser4-Tyr5-D < it6-Leu7-Arg8-Pro9-D-Ala 10-NH2)
Cetrotide® (cetrorelix acetate for injection) 0.25 mg or 3 mg is a sterile lyophilized powder intended for subcutaneous injection after reconstitution with Sterile Water for Injection, USP (pH 5-8), that comes supplied in either a 1.0 mL (for 0.25 mg vial) or 3.0 mL (for 3 mg vial) pre-filled syringe. Each vial of Cetrotide® (cetrorelix) 0.25 mg (multiple dose regimen) contains 0.26-0.27 mg cetrorelix acetate, equivalent to 0.25 mg cetrorelix, and 54.80 mg mannitol. Each vial of Cetrotide (cetrorelix) ® 3 mg (single dose regimen) contains 3.12-3.24 mg cetrorelix acetate, equivalent to 3 mg cetrorelix, and 164.40 mg mannitol.
What are the possible side effects of cetrorelix (Cetrotide)?
Stop using cetrorelix and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
Approximately 3.5 % of female patients treated with cetrorelix have developed ovarian hyperstimulation syndrome (OHSS). Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical...
What are the precautions when taking cetrorelix (Cetrotide)?
Before using cetrorelix, tell your doctor or pharmacist if you are allergic to it; or to other hormones (e.g., GnRH); or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of severe allergic reactions, kidney disease.
This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately.
It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended because it may harm the nursing infant. Consult your doctor...
Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Cetrotide Information
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