Ganirelix

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

• Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

• Ganirelix acetate is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components including dry natural rubber/latex (see HOW SUPPLIED ). Known hypersensitivity to GnRH or any other GnRH analog.contraindicated

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). Directions for Using Ganirelix Acetate Injection Ganirelix acetate injection is supplied in a single dose, sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only. Air bubble(s) may be seen in the pre-filled syringe. This is expected, and removal of the air bubble(s) is not needed. Wash hands thoroughly with soap and water. The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and let the disinfectant dry for at least one minute before proceeding. With syringe held upward, remove needle cover. Pinch up a large area of skin between the finger and thumb.

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 (see CONTRAINDICATIONS and PRECAUTIONS ).

The safety of ganirelix acetate 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 (38) Death Fetal 3.7 (29) Headache 3.0 (24) Ovarian Hyperstimulation Syndrome 2.4 (19) Vaginal Bleeding 1.8 (14) Injection Site Reaction 1.1 (9) Nausea 1.1 (9) Abdominal Pain (gastrointestinal) 1.0 (8) During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylaxis (including anaphylactic shock), angioedema and urticaria have been reported with ganirelix acetate, as early as with the first dose (see PRECAUTIONS ). Congenital Anomalies An observational study in more than 1,000 newborns compared the incidence of congenital anomalies in newborns of women administered ganirelix acetate to historical controls of a GnRH agonist. This study demonstrated that the incidence of congenital anomalies in children born after COH treatment in women using ganirelix acetate was comparable with that reported after a COH treatment cycle using a GnRH agonist.

Pregnancy Ganirelix acetate is contraindicated in pregnant women. When administered from Day 7 to near term to pregnant rats and rabbits at doses up to 10 and 30 mcg/day (approximately 0.4 to 3.2 times the human dose based on body surface area), ganirelix acetate increased the incidence of litter resorption. There was no increase in fetal abnormalities. No treatment-related changes in fertility, physical, or behavioral characteristics were observed in the offspring of female rats treated with ganirelix acetate during pregnancy and lactation. The effects on fetal resorption are logical consequences of the alteration in hormonal levels brought about by the antigonadotropic properties of this drug and could result in fetal loss in humans. Therefore, this drug should not be used in pregnant women (see CONTRAINDICATIONS ).

Metabolism

The pharmacokinetic parameters of single and multiple injections of ganirelix acetate in healthy adult females are summarized in Table I . Steady-state serum concentrations are reached after 3 days of treatment.

There have been no reports of overdosage with ganirelix acetate in humans.

• Jul 29, 1999NDANDA021057Organon Usa Organon
• Nov 30, 2018ANDAANDA204246Sun Pharm
• Apr 7, 2022ANDAANDA212613Amphastar Pharms Inc
• Jun 6, 2022ANDAANDA214996Meitheal
• Feb 28, 2023ANDAANDA215658Gland
• Nov 16, 2023ANDAANDA216075Lupin
• Apr 23, 2025ANDAANDA218855Qilu

1. 1Ovarian Hyperstimulation Syndrome25140%
2. 2Ascites589.3%
3. 3Nausea375.9%
4. 4Dyspnoea345.4%
5. 5Abdominal Pain284.5%
6. 6Drug Ineffective264.1%
7. 7Headache264.1%
8. 8Pleural Effusion213.3%
9. 9Abdominal Distension203.2%
10. 10Fatigue203.2%
11. 11Maternal Exposure Before Pregnancy193.0%
12. 12Needle Issue172.7%
13. 13No Adverse Event172.7%
14. 14Vomiting172.7%
15. 15Injection Site Pain162.6%

The 10 most recently updated of 104 ClinicalTrials.gov registrations naming Ganirelix as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?
  Not yet recruiting · Observational · 20 enrolled · ART Fertility Clinics LLC
  NCT06877429updated 2026-05-07
• Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women
  Recruiting · Phase 4 · Interventional · 30 enrolled · University of Delaware
  NCT06745466updated 2026-05-01
• INTEnsity of ovariaN Stimulation and Embryo Quality
  Completed · Phase 4 · Interventional · 110 enrolled · Fundación Santiago Dexeus Font
  NCT04983173updated 2026-04-14
• Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.
  Completed · Phase 4 · Interventional · 150 enrolled · Instituto Bernabeu
  NCT05954962updated 2026-03-27
• IVF Outcomes With Time-Lapse Culture: Comparison Between PPOS and GnRH Antagonist Protocols
  Recruiting · Interventional · 148 enrolled · Hanoi Medical University
  NCT07409493updated 2026-02-13
• PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study
  Recruiting · Phase 4 · Interventional · 60 enrolled · University Hospital, Ghent
  NCT06175832updated 2025-12-26
• DPOS Versus GnRH Antagonist Protocol for Oocyte Accumulation in Low Ovarian Reserve Patients: An RCT
  Recruiting · Interventional · 730 enrolled · Tam Anh TP. Ho Chi Minh General Hospital
  NCT05847283updated 2025-12-10
• Ovarian Hyperstimulation and Fibrin Clot Properties.
  Recruiting · Interventional · 300 enrolled · Jagiellonian University
  NCT04166825updated 2025-12-05
• hCG Priming in Women With Diminished Ovarian Reserve
  Recruiting · Phase 3 · Interventional · 80 enrolled · Kristine Loessl
  NCT07108621updated 2025-09-17
• To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects
  Completed · Phase 3 · Interventional · 317 enrolled · Jiangsu HengRui Medicine Co., Ltd.
  NCT05994378updated 2025-09-15

Frequently asked questions

How does Ganirelix work?

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

What is Ganirelix used for?

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

What class of drug is Ganirelix?

Ganirelix is classified as Anti-gonadotropin-releasing hormones, Gonadotropin Releasing Hormone Receptor Antagonist, Gonadotropin Releasing Hormone Receptor Antagonists, Hormone Receptor Modulators, Decreased GnRH Secretion, Decreased Luteinizing Hormone Secretion.

What are the brand names for Ganirelix?

Ganirelix is marketed under brand names including Fyremadel.

What are the contraindications for Ganirelix?

Ganirelix labeling lists contraindications including: Ganirelix acetate is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components including dry natural rubber/latex (see HOW SUPPLIED ). Known hypersensitivity to GnRH or any other GnRH analog.. Always consult the full prescribing information and a clinician.