Cetrorelix Acetate

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.
• Cetrorelix Acetate for Injection 0.25 mg may be administered subcutaneously once daily during the early- to mid-follicular phase.
• Cetrorelix Acetate for Injection 0.25 mg is administered on either stimulation day 5 (morning or evening) or day 6 (morning) and continued daily until the day of hCG administration.
• When assessment by ultrasound shows a sufficient number of follicles of adequate size, hCG is administered to induce ovulation and final maturation of the oocytes.
• No hCG should be administered if the ovaries show an excessive response to the treatment with gonadotropins to reduce the chance of developing ovarian hyperstimulation syndrome (OHSS).
• Administration Cetrorelix Acetate for Injection 0.25 mg can be administered by the patient herself after appropriate instructions by her doctor.
• Directions for using Cetrorelix Acetate for Injection 0.25 mg with the enclosed needles and pre-filled syringe:
• Wash hands thoroughly with soap and water.
• Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab.
• Twist the injection needle with the yellow mark (20 gauge) on the pre-filled syringe.
• Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial.
• Leaving the syringe in the vial, gently swirl the vial until the solution is clear and without residues.
• Avoid forming bubbles.
• Draw the total contents of the vial into the syringe.
• If necessary, invert the vial and pull back the needle as far as needed to withdraw the entire contents of the vial.
• Replace the needle with the yellow mark by the injection needle with the grey mark (27 gauge).
• Invert the syringe and push the plunger until all air bubbles have been expelled.
• Choose an injection site in the lower abdominal area, preferably around, but staying at least one inch away from the navel.
• Choose a different injection site each day to minimize local irritation.
• Use a second alcohol swab to clean the skin at the injection site and allow alcohol to dry.
• Gently pinch up the skin surrounding the site of injection.
• Inject the prescribed dose as directed by your doctor, nurse or pharmacist.
• Discard unused portion.
• Use the syringe and needles only once.
• Dispose of the syringe and needles properly after use.
• If available, use a medical waste container for disposal.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in older people

Cetrorelix Acetate for Injection is not intended to be used in subjects aged 65 and over.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The safety of 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.
• Cetrorelix Acetate for Injection 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 cetrorelix acetate for injection treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in cetrorelix acetate for injection treated subjects undergoing COS.
• Table 3:
• Adverse Events in ≥1% (WHO preferred term) Cetrorelix Acetate for Injection N=949 % (n) Ovarian Hyperstimulation Syndrome Intensity moderate or severe, or WHO Grade II or III, respectively 3.5 (33) Nausea 1.3 (12) Headache 1.1 (10) 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, cases of mild to moderate Ovarian Hyperstimulation syndrome and cases of hypersensitivity reactions including anaphylactoid reactions have been reported.
• Two stillbirths were reported in Phase 3 studies of cetrorelix acetate for injection.
• Congenital Anomalies Clinical follow-up studies of 316 newborns of women administered cetrorelix acetate for injection 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 cetrorelix acetate for injection is unknown.
• Multiple factors, genetic and others (including, but not limited to ICSI, IVF, gonadotropins, and progesterone) make causal attribution difficult to study.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Prior to therapy with cetrorelix acetate for injection, patients should be informed of the duration of treatment and monitoring procedures that will be required.
• The risk of possible adverse reactions should be discussed (see ADVERSE REACTIONS ).
• Cetrorelix Acetate for Injection should not be prescribed if a patient is pregnant.
• If cetrorelix acetate for injection is prescribed to patients for self-administration, information for proper use is given in the Patient Leaflet (see below).

Quoted from the official label, section “Patient Counseling Information”.

What it looks like and how it is packed

• Cetrorelix Acetate for Injection 0.25 mg is available in a carton of one packaged tray (NDC 60505-6270-1).
• Each packaged tray contains:
• one glass vial containing 0.26 to 0.27 mg cetrorelix acetate (corresponding to 0.25 mg cetrorelix) (Cetrorelix Acetate for Injection vial NDC 60505-6281-0), one pre-filled glass syringe with 1 mL of Sterile Water for Injection, (diluent syringe NDC 60505-6276-0), one 20 gauge needle (yellow) and one 27 gauge needle (grey).
• Storage Store cetrorelix acetate for injection 0.25 mg refrigerated, 2°C to 8°C (36°F to 46°F).
• Store the packaged tray in the outer carton in order to protect from light.

Quoted from the official label, section “How Supplied”.

How to store it

Store cetrorelix acetate for injection 0.25 mg refrigerated, 2°C to 8°C (36°F to 46°F). Store the packaged tray in the outer carton in order to protect from light.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 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:
• Cetrorelix acetate (Ac-D-Nal 1 - D -Cpa 2 - D -Pal 3 -Ser 4 -Tyr 5 - D -Cit 6 -Leu 7 -Arg 8 -Pro 9 - D -Ala 10 -NH 2 ) Cetrorelix Acetate for Injection 0.25 mg is a sterile lyophilized powder intended for subcutaneous injection after reconstitution with Sterile Water for Injection, that comes supplied in a 1.0 mL pre-filled syringe.
• Each vial of cetrorelix acetate for injection 0.25 mg contains 0.26 to 0.27 mg cetrorelix acetate, equivalent to 0.25 mg cetrorelix, and 54.80 mg mannitol.
• Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

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