Data from FDA - Curated by EPG Health - Last updated 22 December 2016
Cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose, during post-marketing surveillance (see
The packaging of this product contains
Information for Patients Prior to therapy with Ganirelix Acetate Injection, patients should be informed of
The risk of possible
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
The clinical significance of these findings was not determined.
Carcinogenesis and Mutagenesis,
Ganirelix Acetate did not induce a mutagenic response in the Ames test (S. typhimurium and E. coli) or produce chromosomal
Pregnancy Ganirelix Acetate Injection is contraindicated in pregnant women.
When administered from Day 7 to near term to pregnant
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
Treatment duration for Ganirelix Acetate ranged from 1 to 14 days.
Table IV represents
1 % in Ganirelix Acetate-treated subjects
TABLE IV: Incidence of
1 % in Ganirelix Acetate-treated subjects).
1 % Ganirelix Acetate N=794 % (n) Abdominal
The major congenital
The minor congenital
A subsequent analysis from an observational study in more than 1000 newborns compared the incidence of congenital
This analysis included the 283 newborns in the
This study demonstrated that the incidence of congenital
The causal relationship between these congenital
The incidence of congenital malformations after
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.
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.
Directions for Using Ganirelix
Wash hands thoroughly with soap and water.
The injection site should be swabbed with a disinfectant to remove any surface bacteria.
With syringe held upward, remove needle cover.
Pinch up a
The needle should be inserted at the base of the pinched-up skin at an angle of 45-90° to the skin surface.
If this happens, withdraw the needle slightly and reposition the needle
Alternatively, remove the needle and use a new,
Cover the injection site with a swab containing disinfectant and apply pressure;
Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
|Date Last Revised||15-03-2016|
|Type||HUMAN PRESCRIPTION DRUG|
|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.|