Cetrorelix

Mechanism-of-action classes: Gonadotropin Releasing Hormone Receptor Antagonists; Hormone Receptor Modulators; Pituitary Hormones Receptor Interactions.

• Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

• Cetrorelix acetate for injection is contraindicated under the following conditions: 1. Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol.contraindicated

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: 1. Wash hands thoroughly with soap and water. 2. Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab. 3. Twist the injection needle with the yellow mark (20 gauge) on the pre-filled syringe. 4. Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial. 5. Leaving the syringe in the vial, gently swirl the vial until the solution is clear and without residues. Avoid forming bubbles. 6.

Cetrorelix acetate for injection should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with cetrorelix acetate for injection, pregnancy must be excluded (see CONTRAINDICATIONS and PRECAUTIONS).

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* 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, 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.

There have been no reports of overdosage with cetrorelix acetate for injection 0.25 mg or 3 mg in humans. Single doses up to 120 mg cetrorelix acetate for injection have been well tolerated in patients treated for other indications without signs of overdosage.

• Aug 11, 2000NDANDA021197Emd Serono Inc
• Aug 12, 2022ANDAANDA215737Teva Pharms Inc
• Apr 16, 2024ANDAANDA217776Qilu
• Apr 24, 2024ANDAANDA214540Livzon Grp
• Apr 25, 2024ANDAANDA218150Gland

1. 1Ovarian Hyperstimulation Syndrome15624%
2. 2Drug Ineffective436.5%
3. 3Abortion Spontaneous406.1%
4. 4Premature Ovulation406.1%
5. 5Off Label Use375.6%
6. 6Abdominal Distension294.4%
7. 7Abdominal Pain284.3%
8. 8Ascites284.3%
9. 9Condition Aggravated253.8%
10. 10Nausea253.8%
11. 11Dizziness203.0%
12. 12Generalised Tonic-clonic Seizure203.0%
13. 13Headache203.0%
14. 14Drug Interaction192.9%
15. 15Drug Level Decreased182.7%

The 10 most recently updated of 137 ClinicalTrials.gov registrations naming Cetrorelix as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
  Recruiting · Phase 3 · Interventional · 266 enrolled · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
  NCT07340827updated 2026-06-11
• Dydrogesterone Versus GnRH Antagonist in Poor Responders Undergoing Double Ovarian Stimulation
  Recruiting · Phase 2 · Interventional · 120 enrolled · Bedaya Hospital
  NCT06212102updated 2026-05-04
• Progesterone Primed Protocol Versus GnRH Antagonist in With PCO Undergoing ICSI
  Completed · Phase 2 · Phase 3 · Interventional · 200 enrolled · Beni-Suef University
  NCT05951400updated 2026-04-15
• NATural Ovarian Stimulation
  Completed · Phase 4 · Interventional · 129 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT02892942updated 2026-04-03
• Preservation of Fertility by Ovarian Stimulation Associated With Tamoxifen, Prior Chemotherapy for Breast Cancer
  Active not recruiting · Phase 2 · Interventional · 102 enrolled · Institut Cancerologie de l'Ouest
  NCT02890082updated 2026-03-31
• PErsonalized Addition of Recombinant LH in Ovarian Stimulation
  Recruiting · Phase 4 · Interventional · 120 enrolled · Fundación Santiago Dexeus Font
  NCT04719000updated 2026-03-30
• PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study)
  Active not recruiting · Interventional · 626 enrolled · Mỹ Đức Hospital
  NCT06378268updated 2026-03-20
• Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A
  Not yet recruiting · Phase 3 · Interventional · 204 enrolled · ShangHai Ji Ai Genetics & IVF Institute
  NCT05326087updated 2026-02-02
• Trial Comparing Subcutaneous Natural Progesterone (Prolutex) vs. Cetrorelix Acetate for Luteinizing Hormone Surge Suppression in Freeze-All IVF Cycles.
  Not yet recruiting · Phase 4 · Interventional · 230 enrolled · Trust Fertility Clinic
  NCT07350317updated 2026-01-20
• Effectiveness of Generic Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF
  Recruiting · Interventional · 1,338 enrolled · Northwest Women's and Children's Hospital, Xi'an, Shaanxi
  NCT06023602updated 2025-09-19

Frequently asked questions

How does Cetrorelix work?

Mechanism-of-action classes: Gonadotropin Releasing Hormone Receptor Antagonists; Hormone Receptor Modulators; Pituitary Hormones Receptor Interactions.

What is Cetrorelix used for?

According to FDA labeling, Cetrorelix carries indications including: Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cetrorelix?

Cetrorelix is classified as Anti-gonadotropin-releasing hormones, Gonadotropin Releasing Hormone Receptor Antagonist, Gonadotropin Releasing Hormone Receptor Antagonists, Hormone Receptor Modulators, Pituitary Hormones Receptor Interactions, Decreased GnRH Secretion, Decreased Luteinizing Hormone Secretion, Inhibit Ovulation, Ovarian Luteal Phase Alteration.

What are the brand names for Cetrorelix?

Cetrorelix is marketed under brand names including Cetrotide.

What are the contraindications for Cetrorelix?

Cetrorelix labeling lists contraindications including: Cetrorelix acetate for injection is contraindicated under the following conditions: 1. Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol.. Always consult the full prescribing information and a clinician.