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Ganirelix Acetate
Overview
What is Ganirelix Acetate?
Ganirelix Acetate Injection is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N,N-diethyl-D-homoarginyl-L-leucyl-N,N-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for Ganirelix Acetate is 1570.4 as an anhydrous free base. The structural formula is as follows:
Ganirelix Acetate
Ganirelix Acetate Injection is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each sterile, prefilled syringe contains 250 mcg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF.
What does Ganirelix Acetate look like?
What are the available doses of Ganirelix Acetate?
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What should I talk to my health care provider before I take Ganirelix Acetate?
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How should I use Ganirelix Acetate?
Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
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).
What interacts with Ganirelix Acetate?
- 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 (see ).
What are the warnings of Ganirelix Acetate?
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. If the physician elects to use high dose parenteral therapy, controlled intravenous infusion is advisable (for adults, an infusion rate not exceeding 4 mg furosemide per minute has been used) (see
).
What are the precautions of Ganirelix Acetate?
General
Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose, during post-marketing surveillance (see ). In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions.
The packaging of this product contains natural rubber latex which may cause allergic reactions (see ).
Information for Patients
Prior to therapy with Ganirelix Acetate 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 ).
Ganirelix Acetate should not be prescribed if the patient is pregnant.
Laboratory Tests
A neutrophil count ≥ 8.3 ( x 10/L) was noted in 11.9% (up to 16.8 x 10/L) of all subjects treated within the adequate and well-controlled clinical trials. In addition, downward shifts within the Ganirelix Acetate Injection group were observed for hematocrit and total bilirubin. The clinical significance of these findings was not determined.
Drug Interactions
No formal drug-drug interaction studies have been performed.
Carcinogenesis and Mutagenesis, Impairment of Fertility
Long-term toxicity studies in animals have not been performed with Ganirelix Acetate Injection to evaluate the carcinogenic potential of the drug. Ganirelix Acetate did not induce a mutagenic response in the Ames test and ) or produce chromosomal aberrations in assay using Chinese Hamster Ovary cells.
Pregnancy
Ganirelix Acetate Injection 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 ).
Nursing Mothers
Ganirelix Acetate Injection should not be used by lactating women. It is not known whether this drug is excreted in human milk.
Geriatric Use
Clinical studies with Ganirelix Acetate Injection did not include a sufficient number of subjects aged 65 and over.
What are the side effects of Ganirelix Acetate?
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.
During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose (see ).
| 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) |
Congenital Anomalies
Clinical follow-up studies of 283 newborns of women administered Ganirelix Acetate Injection were reviewed. There were three neonates with major congenital anomalies and 18 neonates with minor congenital anomalies. The major congenital anomalies were: hydrocephalus/meningocele, omphalocele, and Beckwith-Wiedemann Syndrome. The minor congenital anomalies were: nevus, skin tags, sacral sinus, hemangioma, torticollis/asymmetric skull, talipes, supernumerary digit finger, hip subluxation, torticollis/high palate, occiput/abnormal hand crease, hernia umbilicalis, hernia inguinalis, hydrocele, undescended testis, and hydronephrosis.
A subsequent analysis from an observational study in more than 1000 newborns compared the incidence of congenital anomalies in newborns of women administered Ganirelix to historical controls of a GnRH agonist. This analysis included the 283 newborns in the original studies. This study demonstrated that the incidence of congenital anomalies in children born after COH treatment in women using Ganirelix was comparable with that reported after a COH treatment cycle using a GnRH agonist. The causal relationship between these congenital anomalies and Ganirelix Acetate is unknown.
The incidence of congenital malformations after Assisted Reproductive Technology (ART) may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART.
What should I look out for while using Ganirelix Acetate?
Ganirelix Acetate Injection is contraindicated under the following conditions:
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 and ).
What might happen if I take too much Ganirelix Acetate?
There have been no reports of overdosage with Ganirelix Acetate Injection in humans.
How should I store and handle Ganirelix Acetate?
Dispense in a well-closed container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].ArrayDispense in a well-closed container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].ArrayDispense in a well-closed container as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].ArrayGanirelix Acetate Injection is supplied in:Disposable, sterile, ready for use, prefilled 1 mL glass syringes containing 250 mcg/0.5 mL aqueous solution of Ganirelix Acetate closed with a rubber piston that does not contain latex. Each Ganirelix Acetate sterile, prefilled syringe is affixed with a 27 gauge × ½-inch needle . (See .)Ganirelix Acetate Injection is supplied in:Disposable, sterile, ready for use, prefilled 1 mL glass syringes containing 250 mcg/0.5 mL aqueous solution of Ganirelix Acetate closed with a rubber piston that does not contain latex. Each Ganirelix Acetate sterile, prefilled syringe is affixed with a 27 gauge × ½-inch needle . (See .)
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The pharmacokinetic parameters of single and multiple injections of Ganirelix Acetate Injection in healthy adult females are summarized in Table I. Steady-state serum concentrations are reached after 3 days of treatment. The pharmacokinetics of Ganirelix Acetate are dose-proportional in the dose range of 125 to 500 mcg.
Non-Clinical Toxicology
Ganirelix Acetate Injection is contraindicated under the following conditions: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 and ).
No formal drug-drug interaction studies have been performed.
Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose, during post-marketing surveillance (see ). In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions.
The packaging of this product contains natural rubber latex which may cause allergic reactions (see ).
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.
During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose (see ).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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