GANIRELIX ACETATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GANIRELIX ACETATE (UNII: 56U7906FQW) (GANIRELIX - UNII:IX503L9WN0)

Available from:

Gland Pharma Limited

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Ganirelix Acetate Injection is supplied in: Disposable, ready for use, single dose, sterile 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 closed by a needle shield. Packaging components of this product are free from dry natural rubber/latex. Single syringe    NDC 68083-472-01   Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured by: Gland Pharma Limited Hyderabad - 502307, India Revised: 11/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GANIRELIX ACETATE - GANIRELIX ACETATE INJECTION, SOLUTION
GLAND PHARMA LIMITED
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GANIRELIX ACETATE INJECTION
FOR SUBCUTANEOUS USE ONLY
DESCRIPTION
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 single
dose, 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.
CLINICAL PHARMACOLOGY
The pulsatile release of GnRH stimulates the synthesis and secretion
of luteinizing
hormone (LH) and follicle-stimulating hormone (FSH). The frequency of
LH pulses in the
mid and late follicular phase is approximately 1 pulse per hour. These
pulses can be
detected as transient rises in serum LH. At midcycle, a large increase
in GnRH release
results in an LH surge. The midcycle LH surge initiates several
physiologic actions
including: ovulation, resumption of meiosis in the oocyte, and
luteinization. Luteinization
results in a rise in serum progesterone with an accompanying decrease
in estradiol
levels.
Ganirelix Acetate acts by competitively blocking the GnRH receptors on
the pituitary
gonadotroph and subsequent transduction pathway. It induces a rapid,
reversible
suppression of gonadotropin secretion. The suppression of pitui