Data from FDA - Curated by EPG Health - Last updated 22 December 2016

Indication(s)

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

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Advisory information

contraindications
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 (see PRECAUTIONS).
Special warnings and precautions

PRECAUTIONS 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 ADVERSE REACTIONS).

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 HOW SUPPLIED).

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 ADVERSE REACTIONS).

Ganirelix Acetate should not be prescribed if the patient is pregnant.

Laboratory Tests A neutrophil count?

8.3 (x 109/L) was noted in 11.9 % (up to 16.8 x 109/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 (S. typhimurium and E. coli) or produce chromosomal aberrations in in_vitro 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 CONTRAINDICATIONS).

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.

Adverse reactions

ADVERSE REACTIONS 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 (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 anaphylactoid reactions, have been reported, as early as with the first dose (see PRECAUTIONS).

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.

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION 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 sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only.

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.

Vary the injection site a little with each injection.

The needle should be inserted at the base of the pinched-up skin at an angle of 45-90° to the skin surface.

When the needle is correctly positioned, it will be difficult to draw back on the plunger.

If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery.

If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin.

Alternatively, remove the needle and use a new, sterile, prefilled syringe.

Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within one or two minutes.

Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged.

Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.

Use the sterile, prefilled syringe only once and dispose of it properly.

Pregnancy and lactation
Nursing Mothers Ganirelix Acetate Injection should not be used by lactating women. It is not known whether this drug is excreted in human milk.

Interactions

Drug Interactions No formal drug-drug interaction studies have been performed.

More information

Category Value
Authorisation number NDA021057
Orphan designation No
Product NDC 0052-0301
Date Last Revised 15-03-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 855200
Storage and handling Storage Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light.
Marketing authorisation holder Organon USA Inc.