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Ganirelix Acetate 250 ug/.5mL Injection, Solution, 1 syringe — NDC 71288-554-80 (Billing 71288-0554-80)

by Meitheal Pharmaceuticals Inc. · 1 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / .5 mL in 1 SYRINGE, GLASS

This is a package of 1 syringe of Ganirelix Acetate 250 ug/.5mL Injection, Solution from Meitheal Pharmaceuticals Inc., marketed since Jun 2022 and currently FDA-listed; retail pharmacies pay about $62.35 per mL (NADAC). It is this product's only package size.

NDC 71288-0554-80
🏷️ FDA NDC (as labeled) 71288-554-80 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Ganirelix Acetate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 13, 2025 — Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. (Lupin Pharmaceuticals Inc.) · FDA recall D-0220-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71288-554-80
Product NDC 71288-554
11-digit billing NDC 71288055480
NCPDP billing unit ML — per mL (volume)
RxCUI 855200
UNII 56U7906FQW
Application # ANDA214996
SPL Set ID 1f067dfb-f9c7-4020-ab7b-da2ba695ab32
Established class (EPC) Gonadotropin Releasing Hormone Receptor Antagonist
Mechanism of action Gonadotropin Releasing Hormone Receptor Antagonists
Physiologic effect Decreased GnRH Secretion
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-06-06
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance GANIRELIX ACETATE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 047336
GCN 12283
HICL code 025154
Ingredient (HICL) Ganirelix Acetate
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P1
Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones
HIC3 code P1N
Therapeutic class — specific (HIC3) Lhrh(Gnrh) Antagonist,Pituitary Suppressant Agents
AHFS code 68:18.04.00
AHFS class Antigonadtropins
FDB label name GANIRELIX ACET 250 MCG/0.5 ML
FDB brand name Ganirelix Acetate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 047336
  • GCN: 12283
  • HICL (First Databank): 025154
  • AHFS class code: 68:18.04.00
  • RxCUI (RxNorm): 855200
Why two NDCs? The FDA registers this code as 71288-554-80 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71288-0554-80. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Gonadotropin Releasing Hormone Receptor Antagonist class.

Pharmacologic class Gonadotropin Releasing Hormone Receptor Antagonist
Drug family (ATC) Anti-gonadotropin-releasing hormones
How it works Gonadotropin Releasing Hormone Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name GANIRELIX ACET 250 MCG/0.5 ML Ingredient Ganirelix Acetate

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $62.347 $31.17 / 0.5 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 $62.347 $62.347
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71288-0554-80 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / .5 mL in 1 SYRINGE, GLASS 2022-06-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ganirelix Acetate 250 ug/.5mL 00548-5001-00 Amphastar 1 syringe $62.347 AP Availability likely —
Fyremadel 250 ug/.5mL 55566-1010-01 Ferring 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 65219-0028-05 Fresenius 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 70700-0327-98 Xiromed 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 70748-0274-01 Lupin 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mLthis 71288-0554-80 Meitheal 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 83301-0082-01 Mullan 1 syringe $62.347 AP Availability likely —
Ganirelix Acetate 250 ug/.5mL 67184-0574-01 Qilu 1 syringe — AP FDA listed —
Ganirelix Acetate 250 ug/.5mL 68083-0472-01 Gland 1 syringe — AP FDA listed —
Ganirelix Acetate 250 ug/.5mL 78206-0138-01 Organon 1 syringe — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMeitheal Pharmaceuticals Inc.
Application holderMEITHEAL PHARMACEUTICALS INC
FDA applicationANDA214996 (ANDA)
Labeler code71288
First marketedJun 2022
Product typeHuman Prescription Drug
Portfolio158 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

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

⏱️ Dosage and Administration ~2 min read ▾

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 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.

Discard the unused portion and dispose of it properly.

⛔ Contraindications 44 words ▾

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 ).

⚠️ Warnings 41 words ▾

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 ).

🤒 Adverse Reactions ~1 min read ▾

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 in more than 1,000 newborns compared the incidence of congenital anomalies in newborns of women administered ganirelix acetate to historical controls of a GnRH agonist. This study demonstrated that the incidence of congenital anomalies in children born after COH treatment in women using ganirelix acetate was comparable with that reported after a COH treatment cycle using a GnRH agonist. The incidence of congenital malformations after some Assisted Reproductive Technologies (ART) [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception.

This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. The causal relationship between these congenital anomalies and ganirelix acetate injection is unknown.

🔄 Drug Interactions 10 words ▾

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

🤰 Pregnancy 126 words ▾

Pregnancy Ganirelix acetate 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 ).

🧓 Geriatric Use 19 words ▾

Geriatric Use Clinical studies with ganirelix acetate did not include a sufficient number of subjects aged 65 and over.

🆘 Overdosage 13 words ▾

OVERDOSAGE There have been no reports of overdosage with ganirelix acetate in humans.

🧬 Clinical Pharmacology ~3 min read ▾

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 pituitary LH secretion by ganirelix acetate is more pronounced than that of FSH.

An initial release of endogenous gonadotropins has not been detected with ganirelix acetate, which is consistent with an antagonist effect. Upon discontinuation of ganirelix acetate, pituitary LH and FSH levels are fully recovered within 48 hours. Pharmacokinetics The pharmacokinetic parameters of single and multiple injections of ganirelix acetate in healthy adult females are summarized in Table I .

Steady-state serum concentrations are reached after 3 days of treatment. The pharmacokinetics of ganirelix acetate are dose-proportional in the dose range of 125 to 500 mcg. TABLE I: Mean (SD) pharmacokinetic parameters of 250 mcg of ganirelix acetate following a single subcutaneous (SC) injection (n=15) and daily SC injections (n=15) for seven days. t max Time to maximum concentration t ½ Elimination half-life C max Maximum serum concentration AUC Area under the curve; Single dose: AUC 0–∞ ; multiple dose: AUC 0–24 V d Volume of distribution † Based on intravenous administration CL Clearance = Dose/AUC 0–∞ F Absolute bioavailability t max h t 1/2 h C max ng/mL AUC ng•h/mL CL/F L/h V d /F L Ganirelix Acetate single dose 1.1 (0.3) 12.8 (4.3) 14.8 (3.2) 96 (12) 2.4 (0.2) † 43.7 (11.4) † Ganirelix Acetate multiple dose 1.1 (0.2) 16.2 (1.6) 11.2 (2.4) 77.1 (9.8) 3.3 (0.4) 76.5 (10.3) Absorption Ganirelix acetate is rapidly absorbed following subcutaneous injection with maximum serum concentrations reached approximately one hour after dosing.

The mean absolute bioavailability of ganirelix acetate following a single 250-mcg subcutaneous injection to healthy female volunteers is 91.1%. Distribution The mean (SD) volume of distribution of ganirelix acetate in healthy females following intravenous administration of a single 250 mcg dose is 43.7 (11.4) liters (L). In vitro protein binding to human plasma is 81.9%.

Metabolism Following single-dose intravenous administration of radiolabeled ganirelix acetate to healthy female volunteers, ganirelix acetate is the major compound present in the plasma (50–70% of total radioactivity in the plasma) up to 4 hours and urine (17.1–18.4% of administered dose) up to 24 hours. Ganirelix acetate is not found in the feces. The 1–4 peptide and 1–6 peptide of ganirelix acetate are the primary metabolites observed in the feces.

Excretion On average, 97.2% of the total radiolabeled ganirelix acetate dose is recovered in the feces and urine (75.1% and 22.1%, respectively) over 288 h following intravenous single dose administration of 1 mg [ 14 C]-ganirelix acetate. Urinary excretion is virtually complete in 24 h, whereas fecal excretion starts to plateau 192 h after dosing. Special Populations The pharmacokinetics of ganirelix acetate have not been determined in special populations such as geriatric, pediatric, renally impaired and hepatically impaired patients (see PRECAUTIONS ).

Drug-Drug Interactions Formal in vivo or in vitro drug-drug interaction studies have not been conducted (see PRECAUTIONS ). Since ganirelix acetate can suppress the secretion of pituitary gonadotropins, dose adjustm… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 175 words ▾

HOW SUPPLIED Ganirelix Acetate Injection is a colorless, aqueous solution of ganirelix acetate and is supplied as follows: NDC Ganirelix Acetate Injection (250 mcg per 0.5 mL) Package Factor 71288- 554 -80 Disposable, ready for use, prefilled Single-Dose Syringe containing 250 mcg per 0.5 mL of ganirelix acetate, closed with a rubber piston that does not contain latex. Each prefilled syringe is affixed with a 29 gauge x ½-inch needle closed by a rigid needle shield that is not made with natural rubber latex (see CONTRAINDICATIONS and PRECAUTIONS , General ).

1 syringe per carton Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.

The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2025 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

Nanjing, China 210061 Revised: February 2025 8H6AAM9-03

📦 Storage and Handling 80 words ▾

Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.

The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2025 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

Nanjing, China 210061 Revised: February 2025 8H6AAM9-03

📋 Description 142 words ▾

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 9 ,N 10 -diethyl-D-homoarginyl-L-leucyl-N 9 , N 10 -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 per 0.5 mL of ganirelix acetate; 0.1 mg glacial acetic acid, USP; 23.5 mg mannitol, USP; and water for injection, USP adjusted to pH 5.0 with glacial acetic acid, USP and/or sodium hydroxide, NF.

Structural Formula

💬 Information for Patients 49 words ▾

Information for Patients Prior to therapy with ganirelix acetate, 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.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalized and local), including anaphylaxis (including anaphylactic shock), angioedema and urticaria, have been reported with ganirelix acetate, as early as with the first dose, during post-marketing surveillance (see ADVERSE REACTIONS ). If a hypersensitivity reaction is suspected, ganirelix acetate should be discontinued and appropriate treatment administered.

In the absence of clinical experience, ganirelix acetate treatment is not advised in women with severe allergic conditions. The rigid needle shield of this product is not made with natural rubber/latex (see CONTRAINDICATIONS and HOW SUPPLIED ). Information for Patients Prior to therapy with ganirelix acetate, 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 10 9 /L) was noted in 11.9% (up to 16.8 x 10 9 /L) of all subjects treated within the adequate and well-controlled clinical trials.

In addition, downward shifts within the ganirelix acetate 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 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 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 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 did not include a sufficient number of subjects aged 65 and over.

🍼 Nursing Mothers 23 words ▾

Nursing Mothers Ganirelix acetate should not be used by lactating women. It is not known whether this drug is excreted in human milk.

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics The pharmacokinetic parameters of single and multiple injections of ganirelix acetate in healthy adult females are summarized in Table I . Steady-state serum concentrations are reached after 3 days of treatment. The pharmacokinetics of ganirelix acetate are dose-proportional in the dose range of 125 to 500 mcg.

TABLE I: Mean (SD) pharmacokinetic parameters of 250 mcg of ganirelix acetate following a single subcutaneous (SC) injection (n=15) and daily SC injections (n=15) for seven days. t max Time to maximum concentration t ½ Elimination half-life C max Maximum serum concentration AUC Area under the curve; Single dose: AUC 0–∞ ; multiple dose: AUC 0–24 V d Volume of distribution † Based on intravenous administration CL Clearance = Dose/AUC 0–∞ F Absolute bioavailability t max h t 1/2 h C max ng/mL AUC ng•h/mL CL/F L/h V d /F L Ganirelix Acetate single dose 1.1 (0.3) 12.8 (4.3) 14.8 (3.2) 96 (12) 2.4 (0.2) † 43.7 (11.4) † Ganirelix Acetate multiple dose 1.1 (0.2) 16.2 (1.6) 11.2 (2.4) 77.1 (9.8) 3.3 (0.4) 76.5 (10.3) Absorption Ganirelix acetate is rapidly absorbed following subcutaneous injection with maximum serum concentrations reached approximately one hour after dosing.

The mean absolute bioavailability of ganirelix acetate following a single 250-mcg subcutaneous injection to healthy female volunteers is 91.1%. Distribution The mean (SD) volume of distribution of ganirelix acetate in healthy females following intravenous administration of a single 250 mcg dose is 43.7 (11.4) liters (L). In vitro protein binding to human plasma is 81.9%.

Metabolism Following single-dose intravenous administration of radiolabeled ganirelix acetate to healthy female volunteers, ganirelix acetate is the major compound present in the plasma (50–70% of total radioactivity in the plasma) up to 4 hours and urine (17.1–18.4% of administered dose) up to 24 hours. Ganirelix acetate is not found in the feces. The 1–4 peptide and 1–6 peptide of ganirelix acetate are the primary metabolites observed in the feces.

Excretion On average, 97.2% of the total radiolabeled ganirelix acetate dose is recovered in the feces and urine (75.1% and 22.1%, respectively) over 288 h following intravenous single dose administration of 1 mg [ 14 C]-ganirelix acetate. Urinary excretion is virtually complete in 24 h, whereas fecal excretion starts to plateau 192 h after dosing.

🔬 Clinical Studies ~3 min read ▾

Clinical Studies The efficacy of ganirelix acetate was established in two adequate and well-controlled clinical studies which included women with normal endocrine and pelvic ultrasound parameters. The studies intended to exclude subjects with polycystic ovary syndrome (PCOS) and subjects with low or no ovarian reserve. One cycle of study medication was administered to each randomized subject.

For both studies, the administration of exogenous recombinant FSH [Follistim ® (follitropin beta for injection)] 150 IU daily was initiated on the morning of Day 2 or 3 of a natural menstrual cycle. Ganirelix acetate injection was administered on the morning of Day 7 or 8 (Day 6 of recombinant FSH administration). The dose of recombinant FSH administered was adjusted according to individual responses starting on the day of initiation of ganirelix acetate.

Both recombinant FSH and ganirelix acetate were continued daily until at least three follicles were 17 mm or greater in diameter at which time hCG [Pregnyl ® (chorionic gonadotropin for injection, USP)] was administered. Following hCG administration, ganirelix acetate and recombinant FSH administration were discontinued. Oocyte retrieval, followed by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), was subsequently performed.

In a multicenter, double-blind, randomized, dose-finding study, the safety and efficacy of ganirelix acetate were evaluated for the prevention of LH surges in women undergoing COH with recombinant FSH. Ganirelix acetate injection doses ranging from 62.5 mcg to 2,000 mcg and recombinant FSH were administered to 332 patients undergoing COH for IVF (see TABLE II ). Median serum LH on the day of hCG administration decreased with increasing doses of ganirelix acetate.

Median serum E 2 (17β-estradiol) on the day of hCG administration was 1475, 1110, and 1160 pg/mL for the 62.5, 125, and 250 mcg doses, respectively. Lower peak serum E 2 levels of 823, 703, and 441 pg/mL were seen at higher doses of ganirelix acetate 500, 1,000, and 2,000 mcg, respectively. The highest pregnancy and implantation rates were achieved with the 250 mcg dose of ganirelix acetate as summarized in Table II .

TABLE II: Results from the multicenter, double-blind, randomized, dose-finding study to assess the efficacy of ganirelix acetate to prevent premature LH surges in women undergoing COH with recombinant FSH. (Protocol 38602) * Following initiation of ganirelix acetate therapy. Includes subjects who have complied with daily injections ‡ Median values ϒ Mean (standard deviation) † ET: Embryo Transfer Ω As evidenced by ultrasound at 5–6 weeks following ET Daily Dose (mcg) of Ganirelix Acetate 62.5 mcg 125 mcg 250 mcg 500 mcg 1,000 mcg 2,000 mcg No. subjects receiving Ganirelix Acetate 31 66 70 69 66 30 No. subjects with ET † 27 61 62 54 61 27 No. of subjects with LH rise ≥ 10 mIU/mL* 4 6 1 0 0 0 Serum LH (mIU/mL) on day of hCG ‡ 5 th –95 th percentiles 3.6 0.6–19.9 2.5 0.6–11.4 1.7 < 0.25–6.4 1.0 0.4–4.7 0.6 < 0.25–2.2 0.3 < 0.25–0.8 Serum E 2 (pg/mL) on day of hCG ‡ 5 th –95 th percentiles 1475 645–3720 1110 424–3780 1160 384–3910 823 279–2720 703 284–2360 441 166–1940 Vital pregnancy rate Ω per attempt, n (%) 7 (22.6) 17 (25.8) 25 (35.7) 8 (11.6) 9 (13.6) 2 (6.7) per transfer, n (%) 7 (25.9) 17 (27.9) 25 (40.3) 8 (14.8) 9 (14.8) 2 (7.4) Implantation rate (%) ϒ 14.2 (26.8) 16.3 (30.5) 21.9 (30.6) 9.0 (23.7) 8.5 (21.7) 4.9 (20.1) Transient LH rises alone were not deleterious to achieving pregnancy with ganirelix acetate at doses of 125 mcg (3/6 subjects) and 250 mcg (1/1 subjects).

In addition, none of the subjects with LH rises ≥ 10 mIU/mL had premature luteinization indicated by a serum progesterone above 2 ng/mL. A multicenter, open-label, randomized study was conducted to assess the efficacy and safety of ganirelix acetate in women undergoing COH. Follicular phase treatment with ganirelix acetate 250 mcg was studied using a luteal phase GnRH agonist as a reference treatm… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 57 words ▾

Carcinogenesis and Mutagenesis, Impairment of Fertility Long-term toxicity studies in animals have not been performed with ganirelix acetate 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.

📄 Package Label / Principal Display Panel 121 words ▾

PRINCIPAL DISPLAY PANEL – Ganirelix Acetate Injection, 250 mcg per 0.5 mL Syringe Label NDC 71288- 554 -80 Rx Only Ganirelix Acetate Injection 250 mcg per 0.5 mL For Subcutaneous Use Only 250 mcg Single-Dose Sterile Prefilled Syringe - 29 gauge by 1/2” needle Protect from light. Discard unused portion. PRINCIPAL DISPLAY PANEL – Ganirelix Acetate Injection, 250 mcg per 0.5 mL Syringe Label

PRINCIPAL DISPLAY PANEL – Ganirelix Acetate Injection, 250 mcg per 0.5 mL Carton NDC 71288- 554 -80 1 x 250 mcg Single-Dose Sterile Prefilled Syringe 29 gauge by 1/2” needle Rx Only Ganirelix Acetate Injection 250 mcg per 0.5 mL For Subcutaneous Use Only PRINCIPAL DISPLAY PANEL – Ganirelix Acetate Injection, 250 mcg per 0.5 mL Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ganirelix Acetate — the ingredient across all brands.

Top reported reactions

Ovarian Hyperstimulation Syndrome253
Ascites58
Nausea37
Dyspnoea34
Abdominal Pain28
Headache26
Pleural Effusion22

Age at onset

Adult98

Reporter sex

639 reports
Male · 1%
Female · 99%
Unknown · 0%

Serious outcomes

Disabling4
Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 116 21
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 71288-0505-03 · Meitheal 71288-0555-86 · Meitheal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.