Uses
Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
Source: US FDA prescribing information
- Presentations
- 3
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Ganirelix is a gonadotropin releasing hormone receptor antagonist indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation. It is available as injection for subcutaneous use. MedsAcross supplies Ganirelix 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
- Pharmacological class
- Gonadotropin Releasing Hormone Receptor Antagonist, Gonadotropin Releasing Hormone Receptor Antagonists, Decreased GnRH Secretion
- ATC classification
- H01CC01 Ganirelix · Gonadotropin-releasing hormone antagonist
- US FDA first approval
- 29 July 1999
- EU status
- Authorised
- Orphan designation
- No
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Subcutaneous
- Dosage forms
- Injection
- Identifiers
- UNII IX503L9WN0RxCUI 35825CAS 124904-93-4DrugBank DB06785Q5521314
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
After initiating FSH therapy on Day 2 or 3 of the cycle, Ganirelix Acetate Injection 250 mcg may be administered subcutaneously once daily during the mid to late portion of the follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced. Treatment with Ganirelix Acetate should be continued daily until the day of hCG administration. When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS (Ovarian Hyperstimulation Syndrome).
Source: US FDA prescribing information
Contraindications
Ganirelix Acetate Injection is contraindicated under the following conditions: Known hypersensitivity to Ganirelix Acetate or to any of its components. Known hypersensitivity to GnRH or any other GnRH analog. Known or suspected pregnancy.
Source: US FDA prescribing information
Warnings and precautions
Ganirelix Acetate Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Ganirelix Acetate, pregnancy must be excluded. Safe use of Ganirelix Acetate during pregnancy has not been established.
Source: US FDA prescribing information
Side effects
The safety of Ganirelix Acetate Injection was evaluated in two randomized, parallel-group, multicenter controlled clinical studies. Treatment duration for Ganirelix Acetate ranged from 1 to 14 days. Table IV represents adverse events (AEs) from first day of Ganirelix Acetate administration until confirmation of pregnancy by ultrasound at an incidence of ≥ 1% in Ganirelix Acetate-treated subjects without regard to causality. TABLE IV: Incidence of common adverse events (Incidence ≥ 1% in Ganirelix Acetate-treated subjects). Completed controlled clinical studies (All-subjects-treated group). Adverse Events Occurring in ≥ 1% Ganirelix Acetate N=794 % (n) Abdominal Pain (gynecological) 4.8. Death Fetal 3.7. Headache 3.0. Ovarian Hyperstimulation Syndrome 2.4. Vaginal Bleeding 1.8. Injection Site Reaction 1.1. Nausea 1.1. Abdominal Pain (gastrointestinal) 1.0.
Source: US FDA prescribing information
Interactions
No formal drug-drug interaction studies have been performed.
Source: US FDA prescribing information
Storage
Store at 77°F (25°C), excursions permitted to 59°F to 86°F (15°C to 30°C). 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
3 presentations of Ganirelix, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ganirelix 500 mcg/1 mL injectionSubcutaneousGeneric name | — | US FDA | Available on request |
| Ganirelix 250 mcg/0.5 mL injectionSubcutaneousGeneric name | — | US FDA | Available on request |
| Fyremadel 250 mcg/0.5 mL injectionSubcutaneous | Ferring Pharmaceuticals | 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.
Conditions
Conditions linked to Ganirelix in public data. This is not a list of approved uses, see the clinical information.
Questions and answers
Is Ganirelix available for export from India?
Yes, on request. MedsAcross lists 3 presentations of Ganirelix and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Ganirelix have?
The catalogue lists 1 brand names for Ganirelix, including Fyremadel.
Is Ganirelix approved by the US FDA?
Yes. The US FDA first approved Ganirelix on 29 July 1999, according to Drugs@FDA.
Is Ganirelix authorised in the European Union?
Yes. Ganirelix has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Ganirelix need cold chain shipping?
No listed presentation of Ganirelix is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Ganirelix in?
Ganirelix is classified under ATC code H01CC01 (Ganirelix).
References
- Ganirelix Acetate prescribing information (Organon). U.S. National Library of Medicine, DailyMed. Retrieved 29 September 2026
- Orgalutran: European public assessment report (EPAR). European Medicines Agency. Retrieved 18 December 2025
- Ganirelix Gedeon Richter: European public assessment report (EPAR). European Medicines Agency. Retrieved 11 November 2026
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