Ganirelix Acetate 250 ug/.5mL
Ganirelix Acetate · INJECTION · Fresenius Kabi USA, LLC
Ganirelix Acetate is a injection containing ganirelix acetate at 250 ug/.5mL, taken subcutaneous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Ganirelix Acetate
- Generic Name
- Ganirelix Acetate
- NDC Code (Product)
65219-028- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 250 ug/.5mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- ANDA215658
- Marketing Start
- 03/24/2023
Recall History
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Impurities/Degradation Specifications
Sun Pharmaceutical Industries Ltd.
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Lupin Pharmaceuticals Inc.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
Dosage & 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 single dose, sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only. Air bubble(s) may be seen in the pre-filled syringe. This is expected, and removal of the air bubble(s) is not needed. Wash hands thoroughly with soap and water. The most convenient sites for SUBCUTANEOUS inje…
Warnings
WARNINGS 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 CONTRAINDICATIONS and PRECAUTIONS ).
Contraindications
CONTRAINDICATIONS Ganirelix acetate is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components including dry natural rubber/latex (see HOW SUPPLIED ). Known hypersensitivity to GnRH or any other GnRH analog. Known or suspected pregnancy (see PRECAUTIONS ).
Drug Interactions
Drug Interactions No formal drug-drug interaction studies have been performed.
Adverse Reactions
ADVERSE REACTIONS The safety of ganirelix acetate 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 anaphylaxis (including anaphylactic shock), angioedema and urticaria have been reported with ganirelix acetate, as early as with the first dose (see PRECAUTIONS ). Congenital Anomalies An observational study…
Frequently Asked Questions
What is Ganirelix Acetate used for?
Ganirelix Acetate contains Ganirelix Acetate. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is Ganirelix Acetate a controlled substance?
Ganirelix Acetate is not classified as a controlled substance by the DEA.
What is the generic name for Ganirelix Acetate?
The generic name for Ganirelix Acetate is Ganirelix Acetate. There are 2 other brand versions of Ganirelix Acetate.
What is the NDC code for Ganirelix Acetate 250 ug/.5mL?
The NDC (National Drug Code) for Ganirelix Acetate 250 ug/.5mL is 65219-028, listed by Fresenius Kabi USA, LLC.