Cetrorelix: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 10, 2026🚩 Report this page

Cetrorelix

Anti-Gonadotropin-Releasing Hormones

Sold as Cetrotide

GB MHRAEU EMACA Health Canada

Drug class: Anti-Gonadotropin-Releasing Hormones
Availability: See label
Routes: Subcutaneous
Markets covered: 3
Products on record: 5

H01CCAnti-Gonadotropin-Releasing Hormones

Overview

Cetrorelix is an active pharmaceutical ingredient in the Anti-Gonadotropin-Releasing Hormones group (H01CC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	3	April 10, 2026
EU European Union	EMA	1	January 27, 2026
CA Canada	Health Canada	1	March 22, 2025

GBUnited Kingdom· MHRA

3 products

Uses

GBOfficial regulatory label· revised September 12, 2025[1]

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. In clinical trials cetrorelix was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 27, 2026[2]

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. In clinical trials Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicle-stimulating hormone (FSH) suggested similar efficacy.

How to take

CACanada· Health Canada

1 product

Uses

CAOfficial regulatory label· revised March 22, 2025[3]

CETROTIDE® (cetrorelix for injection) is indicated for the prevention of premature ovulation in patients undergoing controlled ovarian stimulation.

How to take

Sources & citations

[1]MHRA (UK) · PL317500174 · revised September 12, 2025
[2]European Medicines Agency · EMEA/H/C/000233 · revised January 27, 2026
[3]Health Canada (DPD) · 02247766 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Cetrorelix should only be prescribed by a specialist experienced in this field Posology The first administration of cetrorelix should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available.
The following injections may be self- administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
25 mg cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening. Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo- allergic reaction to the injection.
Elderly There is no relevant use of cetrorelix in the geriatric population. Paediatric population There is no relevant use of cetrorelix in the paediatric population. Method of administration Cetrorelix is for subcutaneous injection into the lower abdominal wall.
The injection site reactions may be minimised by rotating the injection sites, delaying injection at the same site and injecting the product in a slow rate to facilitate the progressive absorption of the medicinal product.
Administration in the morning:
Treatment with cetrorelix should commence on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction.
e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of cetrorelix may be delayed in absence of follicular growth, although clinical experience is based on starting cetrorelix on day 5 or day 6 of stimulation.
Administration in the evening:
Treatment with cetrorelix should commence on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction.
e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of cetrorelix may be delayed in absence of follicular growth, although clinical experience is based on starting cetrorelix on day 5 or day 6 of stimulation

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised September 12, 2025[1]

Summary of the safety profile The most commonly reported adverse reactions are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. 25 mg. Mild to moderate OHSS (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Inversely, severe OHSS remains uncommon. Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported. Tabulated list of adverse reactions The adverse reactions reported below are classified according to frequency of occurrence as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
MedDRA system organ class (SOC) Common Uncommon Immune system disorders Systemic allergic/pseudo- allergic reactions including life- threatening anaphylaxis. 4). g. erythema, swelling and pruritus) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised September 12, 2025[1]

8). Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with cetrorelix is not advised in women with severe allergic conditions. Ovarian Hyperstimulation Syndrome (OHSS) During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur.
This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins. g. with rest, intravenous electrolytes/colloids and heparin therapy. Luteal phase support should be given according to the reproductive medical centre’s practice.
Repeated ovarian stimulation procedure There is limited experience up to now with the administration of cetrorelix during a repeated ovarian stimulation procedure. Therefore cetrorelix should be used in repeated cycles only after a careful benefit/risk evaluation.
Congenital anomalies The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures.
Limited data from clinical follow-up studies in 316 newborns of women administered cetrorelix for infertility treatments suggest that cetrorelix does not increase the risk of congenital anomalies in the offsprings. Hepatic impairment Cetrorelix has not been studied in patients with hepatic impairment and caution is therefore warranted.
Renal impairment Cetrorelix has not been studied in patients with renal impairment and caution is therefore warranted. 3).

This is not medical advice. Consult a qualified healthcare professional.

Cetrotide should only be prescribed by a specialist experienced in this field. Posology The first administration of Cetrotide should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available.
The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
The contents of 1 vial are to be administered once daily, at 24 h intervals, either in the morning or in the evening. 6). Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.
Elderly There is no relevant use of Cetrotide in the geriatric population. Paediatric population There is no relevant use of Cetrotide in the paediatric population. 3 Method of administration Cetrotide is for subcutaneous injection into the lower abdominal wall.
The injection site reactions may be minimised by rotating the injection sites, delaying injection at the same site and injecting the medicinal product in a slow rate to facilitate the progressive absorption of the medicinal product.
Administration in the morning Treatment with Cetrotide should commence on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction.
e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of Cetrotide may be delayed in absence of follicular growth, although clinical experience is based on starting Cetrotide on day 5 or day 6 of stimulation.
Administration in the evening Treatment with Cetrotide should commence on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction.
e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of Cetrotide may be delayed in absence of follicular growth, although clinical experience is based on starting Cetrotide on day 5 or day 6 of stimulation.
6.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised January 27, 2026[2]

Summary of the safety profile The most commonly reported adverse reactions are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. 25 mg. Mild to moderate OHSS (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure.
Inversely, severe OHSS remains uncommon. Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported. 5 List of adverse reactions The adverse reactions reported below are classified according to frequency of occurrence as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000).
Immune system disorders Uncommon:
Systemic allergic/pseudo-allergic reactions including life-threatening anaphylaxis. 4). g. erythema, swelling and pruritus). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

EUOfficial regulatory label· Warnings and precautions· revised January 27, 2026[2]

8). Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with Cetrotide is not advised in women with severe allergic conditions. Ovarian Hyperstimulation Syndrome (OHSS) During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur.
g. with rest, intravenous electrolytes/colloids and heparin therapy. Luteal phase support should be given according to the reproductive medical centre´s practice. 4 Repeated ovarian stimulation procedure There is limited experience up to now with the administration of cetrorelix during a repeated ovarian stimulation procedure.
Therefore, cetrorelix should be used in repeated cycles only after a careful benefit/risk evaluation. Congenital anomalies The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures.
Limited data from clinical follow-up studies in 316 newborns of women administered cetrorelix for infertility treatments suggest that cetrorelix does not increase the risk of congenital anomalies in the offsprings. Hepatic impairment Cetrorelix has not been studied in patients with hepatic impairment and caution is therefore warranted.
Renal impairment Cetrorelix has not been studied in patients with renal impairment and caution is therefore warranted. 3).

This is not medical advice. Consult a qualified healthcare professional.

1 Recommended Dose and Dosage Adjustment 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. The response should be primarily based on the number and size of the developing follicles as evidenced by ultrasound.
This may be more reliable than by the amount of circulating estradiol. 25 mg dose) as part of the multiple dose protocol during the early- to mid-follicular phase. 25 mg is administered on either stimulation day 5 (morning or evening) or day 6 (morning).
It is administered once daily at the same time each day at 24 hour intervals and continued daily until the day of hCG administration. When assessment by ultrasound shows a sufficient number of follicles of adequate size (≥17 mm in diameter), 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). 25 mg should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available.
The subsequent injections may be self-administered after appropriate instructions by the doctor as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
25 mg The reconstituted product is to be administered subcutaneously. Use immediately after reconstitution. As with all parenteral drug products, reconstituted solutions should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration.
Solution showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. Discard unused portions. 4 Missed Dose If you miss a dose of CETROTIDE (cetrorelix for injection) do not double dose. Discuss with your doctor when you should receive your next dose.
Check with your doctor if you have any questions about this.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]

1 Adverse Reaction Overview The safety of CETROTIDE (cetrorelix 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). 0 % of them were Caucasian.
1 mg to 5 mg as either a single or multiple dose. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 1 (10) Table 3 shows systemic adverse events from the beginning of CETROTIDE (cetrorelix for injection) treatment until confirmation of pregnancy by ultrasound in CETROTIDE (cetrorelix for injection) treated subjects undergoing COS (Controlled Ovarian Stimulation).
g. pain, redness, swelling pruritus, erythema, hematoma and/or irritation at the site of injection) have been commonly reported. Usually, they were of a transient nature and mild intensity. Uncommon cases of systematic allergic/pseudo-allergic reactions including life-threatening anaphylactoid reactions have been observed.
Two stillbirths were reported in Phase 3 studies of CETROTIDE (cetrorelix for injection). Ovarian Hyperstimulation Syndrome (OHSS) During or following controlled ovarian stimulation it is common for mild to moderate ovarian hyperstimulation syndrome (WHO grade I or II) to occur.
). In this potentially serious medical event, the ovaries are massively enlarged, and intravascular fluid volume shifts into the peritoneal space, resulting in hypovolemia, oliguria, hemoconcentration, and massive ascites. The syndrome can usually be avoided by closely monitoring the patient and withholding the hCG if ovarian response becomes excessive.
Severe OHSS (WHO grade III) is uncommon. Congenital Anomalies Clinical follow-up studies of 316 newborns of women administered CETROTIDE (cetrorelix 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 Cetrotide® (cetrorelix acetate) Page 9 of 26 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 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.

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]

General CETROTIDE (cetrorelix for injection) should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with CETROTIDE (cetrorelix for injection), pregnancy must be excluded (see CONTRAINDICATIONS).
Prior to therapy with CETROTIDE (cetrorelix 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).
CETROTIDE (cetrorelix for injection) should not be prescribed if a patient is pregnant. If CETROTIDE (cetrorelix for injection) is prescribed to patients for self-administration, information for proper use is given in the Patient Insert (see CONSUMER INFORMATION).
25 mg cetrorelix (as cetrorelix acetate), Powder for Solution Mannitol Cetrotide® (cetrorelix acetate) Page 6 of 26 Carcinogenesis and Mutagenesis Long-term carcinogenicity studies in animals have not been performed with cetrorelix acetate.
Cetrorelix acetate was not genotoxic in vitro (Ames test, HPRT test, chromosome aberration test) or in vivo (chromosome aberration test, mouse micronucleus test). Cetrorelix acetate induced polyploidy in CHL-Chinese hamster lung fibroblasts, but not in V79-Chinese hamster lung fibroblasts, cultured peripheral human lymphocytes or in an in-vitro micronucleus test in the CHL-cell line.
Immune Caution is advised in patients with hypersensitivity to GnRH analogs. These patients should be carefully monitored after the first injection, where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available.
Therefore, it is recommended that a physician supervises the first administration. Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with CETROTIDE (cetrorelix for injection), is not advised in women with severe allergic conditions.
Efficacy and safety (immunogenicity and/or sensitization) have not been extensively evaluated in women undergoing multiple treatment cycles with CETROTIDE (cetrorelix for injection). However, hypersensitivity, antibody formation, and acute anaphylactic reaction have been reported with GnRH analogs.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

EUEuropean Union· EMA

CACanada· Health Canada

Drugs in the same class

Sources & citations