Medical Editor: John P. Cunha, DO, FACOEP
Cetrotide (cetrorelix acetate) blocks the hormone (gonadotropin-releasing hormone-GnRH) that causes eggs to be released from the ovaries and is used to prevent premature ovulation during controlled ovarian stimulation. Common side effects include:
- headache, and
- injection site reactions (pain, bruising, redness, swelling, itching).
A small number of female patients treated with Cetrotide 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. Tell your doctor immediately or seek emergency medical attention if you develop any of these symptoms.
Ovarian stimulation therapy with gonadotropins (FSH, hMG) is started on cycle Day 2 or 3. The dose of gonadotropins should be adjusted according to individual response. Cetrotide may be given subcutaneously either once daily (0.25 mg dose) or once (3 mg dose) during the early- to mid-follicular phase. It is not known whether other medications will interact with Cetrotide. Tell your doctor all prescription or over-the-counter medicines and supplements you use. Cetrotide must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Breastfeeding while using this drug is not recommended because it may harm the nursing infant.
Our Cetrotide (cetrorelix acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
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
- 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.
Read the entire detailed patient monograph for Cetrotide (Cetrorelix)
The safety of Cetrotide® (cetrorelix acetate for injection) in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 94.0% of them were Caucasian. Cetrotide® was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose.
Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of Cetrotide® treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in Cetrotide® treated subjects undergoing COS.
Table 3: Adverse Events in ≥ 1%
|(WHO preferred term)||Cetrotide®
N=949 % (n)
|Ovarian Hyperstimulation Syndrome*||3.5 (33)|
|* Intensity moderate or severe, or WHO Grade II or III, respectively|
Local site reactions (e.g. redness, erythema, bruising, itching, swelling, and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration. During post-marketing surveillance, rare cases of hypersensitivity reactions including anaphylactoid reactions have been reported.
Two stillbirths were reported in Phase 3 studies of Cetrotide®.
Clinical follow-up studies of 316 newborns of women administered Cetrotide® were reviewed. One infant of a set of twin neonates was found to have anencephaly at birth and died after four days. The other twin was normal. Developmental findings from ongoing baby follow-up included a child with a ventricular septal defect and another child with bilateral congenital glaucoma.
Four pregnancies that resulted in therapeutic abortion in Phase 2 and Phase 3 controlled ovarian stimulation studies had major anomalies (diaphragmatic hernia, trisomy 21, Klinefelter syndrome, polymalformation, and trisomy 18). In three of these four cases, intracytoplasmic sperm injection (ICSI) was the fertilization method employed; in the fourth case, in vitro fertilization (IVF) was the method employed.
The minor congenital anomalies reported include: supernumerary nipple, bilateral strabismus, imperforate hymen, congenital nevi, hemangiomata, and QT syndrome.
The causal relationship between the reported anomalies and Cetrotide® is unknown. Multiple factors, genetic and others (including, but not limited to ICSI, IVF, gonadotropins, and progesterone) make causal attribution difficult to study.
Read the entire FDA prescribing information for Cetrotide (Cetrorelix)