Uses
Cetrotide ® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
Source: US FDA prescribing information
Molecule
Cetrorelix
Also known as cetrorelix acetate
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Cetrorelix is a prescription medicine indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. It is available as kits for subcutaneous use. MedsAcross supplies Cetrorelix for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- ATC classification
- H01CC02 Cetrorelix · Gonadotropin-releasing hormone antagonist
- US FDA first approval
- 11 August 2000
- EU status
- Authorised
- Orphan designation
- No
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Subcutaneous
- Dosage forms
- Kit
- Identifiers
- UNII OON1HFZ4BARxCUI 68147CAS 120287-85-6DrugBank DB00050Q5065704
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
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 ® (cetrorelix acetate for injection) 0.25 mg may be administered subcutaneously once daily during the early- to mid-follicular phase. Cetrotide ® 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).
Source: US FDA prescribing information
Contraindications
Cetrotide ® (cetrorelix acetate for injection) is contraindicated under the following conditions: Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol. Known hypersensitivity to GnRH or any other GnRH analogs. Known or suspected pregnancy, and lactation. Severe renal impairment
Source: US FDA prescribing information
Warnings and precautions
Cetrotide ® (cetrorelix acetate for injection) should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with Cetrotide ®, pregnancy must be excluded.
Source: US FDA prescribing information
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 ® 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 Intensity moderate or severe, or WHO Grade II or III, respectively 3.5. Nausea 1.3. Headache 1.1.
Source: US FDA prescribing information
Interactions
No formal drug interaction studies have been performed with Cetrotide ®.
Source: US FDA prescribing information
Storage
Store Cetrotide ® 0.25 mg refrigerated, 2ºC - 8ºC (36ºF - 46ºF). Store the packaged tray in the outer carton in order to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Cetrorelix, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Cetrotide kitSubcutaneous Cold chain | EMD Serono | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Cetrorelix available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Cetrorelix and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Cetrorelix have?
The catalogue lists 1 brand names for Cetrorelix, including Cetrotide.
Is Cetrorelix approved by the US FDA?
Yes. The US FDA first approved Cetrorelix on 11 August 2000, according to Drugs@FDA.
Is Cetrorelix authorised in the European Union?
Yes. Cetrorelix has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Cetrorelix need cold chain shipping?
At least one listed presentation of Cetrorelix must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Which ATC class is Cetrorelix in?
Cetrorelix is classified under ATC code H01CC02 (Cetrorelix).
References
- Cetrotide prescribing information (EMD Serono). U.S. National Library of Medicine, DailyMed. Retrieved 22 September 2025
- Cetrotide: European public assessment report (EPAR). European Medicines Agency. Retrieved 27 January 2026
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