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DRUG DESCRIPTION
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:
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(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...
Read All Potential Side Effects and See Pictures of Cetrotide »
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...
Read All Potential Precautions of Cetrotide »
Cetrotide Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these rare but very serious side effects occur: severe pain/swelling/cramping in the abdomen.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: 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 before breast-feeding.
Cetrotide Patient Information Including Side Effects
Brand Names: Cetrotide
Generic Name: cetrorelix (injectable) (Pronunciation: SE troe REL ix)
- What is cetrorelix (Cetrotide)?
- What are the possible side effects of cetrorelix (Cetrotide)?
- What is the most important information I should know about cetrorelix (Cetrotide)?
- What should I discuss with my healthcare provider before using cetrorelix (Cetrotide)?
- How should I use cetrorelix (Cetrotide)?
- What happens if I miss a dose (Cetrotide)?
- What happens if I overdose (Cetrotide)?
- What should I avoid while using cetrorelix (Cetrotide)?
- What other drugs will affect cetrorelix (Cetrotide)?
- Where can I get more information?
What is cetrorelix (Cetrotide)?
Cetrorelix blocks the effects of the naturally occurring gonadotropin-releasing hormone (GnRH). GnRH controls the release of another hormone, luteinizing hormone (LH), which induces ovulation (release of an egg from the ovary) during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix blocks this undesirable premature ovulation.
Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation.
Cetrorelix may also be used for purposes other than those listed in this medication guide.
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 attention if you develop any of these symptoms.
Other side effects may also occur. Notify your doctor if you experience
- nausea;
- headache; or
- redness, bruising, itching, or swelling at the injection site.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about cetrorelix (Cetrotide)?
Do not use cetrorelix if you are pregnant. Cetrorelix is in the FDA pregnancy category X. This means that cetrorelix is known to cause birth defects.
Talk to your doctor before using cetrorelix if you have kidney disease or any renal (kidney) problems. Cetrorelix should not be used in patients with severe renal impairment.
- Cetrotide
Related Drugs Index:
Cetrotide, Cetrorelix, Buy Cetrotide