A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Antagon Indications, Dosage, Storage, Stability - Ganirelix
Antagon Indications, Dosage, Storage, Stability - Ganirelix
INDICATIONS
AND USES
Antagon™ (ganirelix acetate) Injection is indicated for the inhibition of premature
LH surges in women undergoing controlled ovarian hyperstimulation.
DOSAGE AND ADMINISTRATION
After initiating FSH therapy on Day 2 or 3 of the cycle, Antagon™ (ganirelix
acetate) Injection 250 µg may be administered subcutaneously once daily during
the early to mid follicular phase. By taking advantage of endogenous pituitary
FSH secretion, the requirement for exogenously administered FSH may be reduced.
Treatment with Antagon™ 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.
Directions for Using Antagon™ (ganirelix acetate) Injection
- Antagon™ 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.
- 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.
HOW SUPPLIED
Antagon™ (ganirelix acetate) Injection is supplied in:
Disposable, sterile, prefilled 1 mL glass syringes containing 250 µg/0.5
mL of ganirelix acetate. Each Antagon™ sterile, prefilled syringe is affixed
with a 27 gauge × ˝ inch needle and is blister-packed.
Single syringe NDC 0052-0301-51
Box of 5 NDC 0052-0301-61
Box of 50 NDC 0052-0301-71
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled
Room Temperature]. Protect from light.
Rx only
Manufactured for Organon Inc.
West Orange, NJ 07052
by Vetter Pharma-Fertigung GmbH & Co. KG
Ravensburg, Germany
and packaged by Organon (Ireland) Ltd, Swords Co.
Dublin, Ireland
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