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Cetrotide

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Cetrotide

Cetrotide Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cetrotide (cetrorelix acetate) is used to prevent premature ovulation during controlled ovarian stimulation. It blocks the hormone (gonadotropin-releasing hormone-GnRH) that causes eggs to be released from the ovaries. Common side effects include nausea, headache, and pain/bruising/redness/swelling/itching at the injection site.

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. Breast-feeding 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cetrotide in Detail - Patient Information: Side Effects

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.

Read the entire detailed patient monograph for Cetrotide (Cetrorelix) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cetrotide Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, headache, and pain/bruising/redness/swelling/itching at the injection site may occur. If any of these effects persist or worsen, tell your doctor promptly.

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.

Read the entire patient information overview for Cetrotide (Cetrorelix)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cetrotide FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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® (cetrorelix) 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® (cetrorelix) treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in Cetrotide® (cetrorelix) treated subjects undergoing COS.

Table 3: Adverse Events in ≥ 1%


(WHO preferred term)
Cetrotide* N=949
% (n)
Ovarian Hyperstirnulation Syndrome# 3.5(33)
Nausea 1,3(12)
Headache 1.1 (10)
# 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® (cetrorelix) .

Congenital Anomalies

Clinical follow-up studies of 316 newborns of women administered Cetrotide® (cetrorelix) 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® (cetrorelix) 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) »

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Cetrotide - User Reviews

Cetrotide User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Cetrotide sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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