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Cetrorelix Acetate Kit — NDC 71288-0558-90 package photo
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Cetrorelix Acetate Kit — NDC 71288-558-90 (Billing 71288-0558-90)

by Meitheal Pharmaceuticals Inc. · 1 KIT in 1 CARTON * 2 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 SYRINGE, GLASS

This is a package of Cetrorelix Acetate Kit from Meitheal Pharmaceuticals Inc., marketed since Apr 2024 and currently FDA-listed, this package's marketing is listed to end Apr 2027. It is this product's only package size.

NDC 71288-0558-90
🏷️ FDA NDC (as labeled) 71288-558-90 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 Oct 1, 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

🚨
Active recall for this product.
Class II · Feb 9, 2026 — Defective Delivery System: Missing or duplicated needles within the injection kit (Meitheal Pharmaceuticals, Inc) · FDA recall D-0340-2026
Lots / codes: Lot Q4E0112A, Exp.: 30 Apr 2027 · reported Feb 18, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71288-558-90
Product NDC 71288-558
11-digit billing NDC 71288055890
NCPDP billing unit EA — each (per item)
Application # ANDA214540
SPL Set ID 9b3057ac-6cac-4509-a355-df76247b992c
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-24
Marketing end 2027-04-30
Route SUBCUTANEOUS
Dosage form KIT
TE code (Orange Book) AP · RLD · RS

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

GCN Seq No 047451
GCN 12526
HICL code 020305
Ingredient (HICL) Cetrorelix 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 CETRORELIX ACETATE 0.25 MG VL
FDB brand name Cetrorelix Acetate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 047451
  • GCN: 12526
  • HICL (First Databank): 020305
  • AHFS class code: 68:18.04.00
Why two NDCs? The FDA registers this code as 71288-558-90 — 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 → 71288-0558-90. 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.

Clinical

Label name CETRORELIX ACETATE 0.25 MG VL Ingredient Cetrorelix 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
71288-0558-90 You're viewing this Main listing 1 KIT in 1 CARTON * 2 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 SYRINGE, GLASS 2024-04-24 Apr 30, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetrotide 44087-1225-01 EMD 1 kit $306.057 AP FDA listed —
Cetrorelix 00480-5795-08 Teva 1 kit — — Discontinued —
Cetrorelix acetate 60505-6270-01 Apotex 1 kit — AP FDA listed —
cetrorelix acetate 65219-0292-77 FRESENIUS 1 kit — AP FDA listed —
Cetrorelix acetate 67184-0605-02 Qilu 1 kit — AP FDA listed —
cetrorelix acetate 68083-0600-01 Gland 1 kit — AP FDA listed —
Cetrorelix Acetatethis 71288-0558-90 Meitheal 1 kit — 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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 holderLIVZON GROUP PHARMACEUTICAL FACTORY
FDA applicationANDA214540 (ANDA)
Labeler code71288
First marketedApr 2024
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 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 22 words ▾

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

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Ovarian stimulation therapy with gonadotropins (FSH, hMG) is started on cycle Day 2 or 3. The dose of gonadotropins should be adjusted according to individual response. Cetrorelix acetate for injection 0.25 mg may be administered subcutaneously once daily during the early- to mid-follicular phase.

Cetrorelix acetate for injection 0.25 mg is administered on either stimulation day 5 (morning or evening) or day 6 (morning) and continued daily until the day of hCG administration. When assessment by ultrasound shows a sufficient number of follicles of adequate size, hCG is administered to induce ovulation and final maturation of the oocytes. No hCG should be administered if the ovaries show an excessive response to the treatment with gonadotropins to reduce the chance of developing ovarian hyperstimulation syndrome (OHSS).

Administration Cetrorelix acetate for injection 0.25 mg can be administered by the patient herself after appropriate instructions by her doctor. Directions for using cetrorelix acetate for injection 0.25 mg with the enclosed needles and prefilled syringe: Wash hands thoroughly with soap and water. Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab.

Twist the injection needle with the yellow mark (20-gauge) on the prefilled syringe. Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial. Leaving the syringe in the vial, gently swirl the vial until the solution is clear and without residues.

Avoid forming bubbles. Draw the total contents of the vial into the syringe. If necessary, invert the vial and pull back the needle as far as needed to withdraw the entire contents of the vial.

Replace the needle with the yellow mark by the injection needle with the grey mark (27-gauge). Invert the syringe and push the plunger until all air bubbles have been expelled. Choose an injection site in the lower abdominal area, preferably around, but staying at least one inch away from the navel.

Choose a different injection site each day to minimize local irritation. Use a second alcohol swab to clean the skin at the injection site and allow alcohol to dry. Gently pinch up the skin surrounding the site of injection.

Inject the prescribed dose as directed by your doctor, nurse or pharmacist. Use the syringe and needles only once. Dispose of the syringe and needles properly after use.

If available, use a medical waste container for disposal.

⛔ Contraindications 39 words ▾

CONTRAINDICATIONS Cetrorelix acetate is contraindicated under the following conditions: Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol. Known hypersensitivity to GnRH or any other GnRH analogs. Known or suspected pregnancy, and lactation (see PRECAUTIONS ). Severe renal impairment

⚠️ Warnings 31 words ▾

WARNINGS Cetrorelix acetate for injection should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with cetrorelix acetate, pregnancy must be excluded (see CONTRAINDICATIONS and PRECAUTIONS ).

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The safety of cetrorelix acetate in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 94.0% of them were Caucasian.

Cetrorelix acetate was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose. Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of cetrorelix acetate treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in cetrorelix acetate treated subjects undergoing COS. Table 3: Adverse Events in ≥1% * Intensity moderate or severe, or WHO Grade II or III, respectively (WHO preferred term) Cetrorelix Acetate N=949 % (n) Ovarian Hyperstimulation Syndrome * 3.5 (33) Nausea 1.3 (12) Headache 1.1 (10) Local site reactions (e.g. redness, erythema, bruising, itching, swelling, and pruritus) were reported.

Usually, they were of a transient nature, mild intensity and short duration. During post-marketing surveillance, cases of mild to moderate Ovarian Hyperstimulation syndrome and cases of hypersensitivity reactions including anaphylactoid reactions have been reported. Two stillbirths were reported in Phase 3 studies of cetrorelix acetate.

Congenital Anomalies Clinical follow-up studies of 316 newborns of women administered cetrorelix acetate were reviewed. One infant of a set of twin neonates was found to have anencephaly at birth and died after four days. The other twin was normal.

Developmental findings from ongoing baby follow-up included a child with a ventricular septal defect and another child with bilateral congenital glaucoma. Four pregnancies that resulted in therapeutic abortion in Phase 2 and Phase 3 controlled ovarian stimulation studies had major anomalies (diaphragmatic hernia, trisomy 21, Klinefelter syndrome, polymalformation, and trisomy 18). In three of these four cases, intracytoplasmic sperm injection (ICSI) was the fertilization method employed; in the fourth case, in vitro fertilization (IVF) was the method employed.

The minor congenital anomalies reported include: supernumerary nipple, bilateral strabismus, imperforate hymen, congenital nevi, hemangiomata, and QT syndrome. The causal relationship between the reported anomalies and cetrorelix acetate is unknown. Multiple factors, genetic and others (including, but not limited to ICSI, IVF, gonadotropins, and progesterone) make causal attribution difficult to study.

🔄 Drug Interactions 29 words ▾

Drug-Drug Interactions No formal drug-drug interaction studies have been performed with cetrorelix acetate (see PRECAUTIONS ).

Drug Interactions No formal drug interaction studies have been performed with cetrorelix acetate.

🤰 Pregnancy 182 words ▾

Pregnancy (see CONTRAINDICATIONS ) Cetrorelix acetate is contraindicated in pregnant women. When administered to rats for the first seven days of pregnancy, cetrorelix acetate did not affect the development of the implanted conceptus at doses up to 38 mcg/kg (approximately 1 times the recommended human therapeutic dose based on body surface area). However, a dose of 139 mcg/kg (approximately 4 times the human dose) resulted in a resorption rate and a post-implantation loss of 100%.

When administered from day 6 to near term to pregnant rats and rabbits, very early resorptions and total implantation losses were seen in rats at doses from 4.6 mcg/kg (0.2 times the human dose) and in rabbits at doses from 6.8 mcg/kg (0.4 times the human dose). In animals that maintained their pregnancy, there was no increase in the incidence of fetal abnormalities. The fetal resorption observed in animals is a logical consequence of the alteration in hormonal levels effected by the antigonadotrophic properties of cetrorelix acetate, which could result in fetal loss in humans as well.

Therefore, this drug should not be used in pregnant women.

🧓 Geriatric Use 16 words ▾

Geriatric Use Cetrorelix acetate is not intended to be used in subjects aged 65 and over.

🆘 Overdosage 40 words ▾

OVERDOSAGE There have been no reports of overdosage with cetrorelix acetate 0.25 mg or 3 mg in humans. Single doses up to 120 mg cetrorelix acetate have been well tolerated in patients treated for other indications without signs of overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY GnRH induces the production and release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) from the gonadotrophic cells of the anterior pituitary. Due to a positive estradiol (E2) feedback at midcycle, GnRH liberation is enhanced resulting in an LH-surge. This LH-surge induces the ovulation of the dominant follicle, resumption of oocyte meiosis and subsequently luteinization as indicated by rising progesterone levels.

Cetrorelix acetate competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner. The onset of LH suppression is approximately one hour with the 3 mg dose and two hours with the 0.25 mg dose. This suppression is maintained by continuous treatment and there is a more pronounced effect on LH than on FSH.

An initial release of endogenous gonadotropins has not been detected with cetrorelix acetate, which is consistent with an antagonist effect. The effects of cetrorelix acetate on LH and FSH are reversible after discontinuation of treatment. In women, cetrorelix acetate delays the LH-surge, and consequently ovulation, in a dose-dependent fashion.

FSH levels are not affected at the doses used during controlled ovarian stimulation. Following a single 3 mg dose of cetrorelix acetate, duration of action of at least 4 days has been established. A dose of cetrorelix acetate 0.25 mg every 24 hours has been shown to maintain the effect.

Pharmacokinetics The pharmacokinetic parameters of single and multiple doses of cetrorelix acetate in adult healthy female subjects are summarized in Table 1 . Table 1: Pharmacokinetic parameters of cetrorelix acetate following 3 mg single or 0.25 mg single and multiple (daily for 14 days) subcutaneous (sc) administration t max Time to reach observed maximum plasma concentration t 1/2 Elimination half-life C max Maximum plasma concentration; multiple dose C ss, max AUC Area under the curve; single dose AUC 0-inf , multiple dose AUCt CL Total plasma clearance Vz Volume of distribution Geometric mean (95% CI ln ), * arithmetic mean, † median (min-max) ‡ Based on iv administration (n=6, separate study 0013) Single dose 3 mg Single dose 0.25 mg Multiple dose 0.25 mg No. of subjects 12 12 12 t max † [h] 1.5 (0.5-2) 1.0 (0.5-1.5) 1.0 (0.5-2) t 1/2 † [h] 62.8 (38.2-108) 5.0 (2.4-48.8) 20.6 (4.1-179.3) C max [ng/mL] 28.5 (22.5-36.2) 4.97 (4.17-5.92) 6.42 (5.18-7.96) AUC [ng·h/mL] 536 (451-636) 31.4 (23.4-42.0) 44.5 (36.7-54.2) CL * [mL/min·kg] 1.28 ‡ Vz * [L/kg] 1.16 ‡ Absorption Cetrorelix acetate is rapidly absorbed following subcutaneous injection, maximal plasma concentrations being achieved approximately one to two hours after administration.

The mean absolute bioavailability of cetrorelix acetate following subcutaneous administration to healthy female subjects is 85%. Distribution The volume of distribution of cetrorelix acetate following a single intravenous dose of 3 mg is about 1 L/kg. In vitro protein binding to human plasma is 86%.

Cetrorelix acetate concentrations in follicular fluid and plasma were similar on the day of oocyte pick-up in patients undergoing controlled ovarian stimulation. Following subcutaneous administration of cetrorelix acetate 0.25 mg and 3 mg, plasma concentrations of cetrorelix acetate were below or in the range of the lower limit of quantitation on the day of oocyte pick-up and embryo transfer. Metabolism After subcutaneous administration of 10 mg cetrorelix acetate to females and males, cetrorelix acetate and small amounts of (1-9), (1-7), (1-6), and (1-4) peptides were found in bile samples over 24 hours.

In in vitro studies, cetrorelix acetate was stable against phase I- and phase II-metabolism. Cetrorelix acetate was transformed by peptidases, and the (1-4) peptide was the predominant metabolite. Excretion Following subcutaneous administration of 10 mg cetrorelix acetate to males and females, only unchanged cetrorelix acetate was detec… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 169 words ▾

HOW SUPPLIED Cetrorelix Acetate for Injection 0.25 mg is supplied as follows: NDC Cetrorelix Acetate for Injection 0.25 mg Kit Package Factor 71288- 558 -90 One Single-Dose Vial of Cetrorelix Acetate for Injection (NDC 71288- 556 -02): glass vial containing 0.26-0.27 mg cetrorelix acetate (equivalent to 0.25 mg cetrorelix) as a sterile lyophilized powder and One Single-Dose Prefilled Syringe of Diluent (NDC 71288- 557 -81): glass syringe filled with 1 mL Sterile Water for Injection and One 20-gauge needle (yellow) and one 27-gauge needle (grey) 1 vial in a packaged tray per carton 1 syringe in a packaged tray per carton Storage Store refrigerated 2° to 8ºC (36° to 46ºF).

Store the packaged tray in the outer carton in order to protect from light. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free.

The container closure is not made with natural rubber latex. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2024 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. Nanjing, China 210061 Revised: September 2024 8F5AAME-03

📦 Storage and Handling 68 words ▾

Storage Store refrigerated 2° to 8ºC (36° to 46ºF). Store the packaged tray in the outer carton in order to protect from light. Discard unused portion.

Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2024 Meitheal Pharmaceuticals Inc. Mfd. by Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

Nanjing, China 210061 Revised: September 2024 8F5AAME-03

📋 Description 115 words ▾

DESCRIPTION Cetrorelix Acetate for Injection is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. Cetrorelix acetate is an analog of native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, and 10. The molecular formula is Acetyl-D-3-(2′-naphtyl)-alanine-D-4-chlorophenylalanine-D-3-(3′-pyridyl)-alanine-L-serine-L-tyrosine-D-citruline-L-leucine-L-arginine-L-proline-D-alanine-amide, and the molecular weight is 1431.06, calculated as the anhydrous free base.

The structural formula is as follows: Cetrorelix Acetate for Injection 0.25 mg is a sterile lyophilized powder intended for subcutaneous injection after reconstitution with Sterile Water for Injection, that comes supplied in a 1 mL prefilled syringe. Each vial of Cetrorelix Acetate for Injection 0.25 mg contains 0.26-0.27 mg cetrorelix acetate, equivalent to 0.25 mg cetrorelix, and 54.80 mg mannitol. Structural Formula

💬 Information for Patients 70 words ▾

Information for Patients Prior to therapy with cetrorelix 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 ). Cetrorelix acetate should not be prescribed if a patient is pregnant.

If cetrorelix acetate is prescribed to patients for self-administration, information for proper use is given in the Patient Leaflet (see below).

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Cases of hypersensitivity reactions, including anaphylactoid reactions with the first dose, have been reported during post-marketing surveillance (see ADVERSE REACTIONS ). A severe anaphylactic reaction associated with cough, rash, and hypotension, was observed in one patient after seven months of treatment with cetrorelix acetate (10 mg/day) in a study for an indication unrelated to infertility. Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition.

Treatment with cetrorelix acetate is not advised in women with severe allergic conditions. Information for Patients Prior to therapy with cetrorelix 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 ).

Cetrorelix acetate should not be prescribed if a patient is pregnant. If cetrorelix acetate is prescribed to patients for self-administration, information for proper use is given in the Patient Leaflet (see below). Laboratory Tests After the exclusion of preexisting conditions, enzyme elevations (ALT, AST, GGT, alkaline phosphatase) were found in 1-2% of patients receiving cetrorelix acetate during controlled ovarian stimulation.

The elevations ranged up to three times the upper limit of normal. The clinical significance of these findings was not determined. During stimulation with human menopausal gonadotropin, cetrorelix acetate had no notable effects on hormone levels aside from inhibition of LH surges.

Drug Interactions No formal drug interaction studies have been performed with cetrorelix acetate. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in animals have not been performed with cetrorelix acetate. Cetrorelix acetate was not genotoxic in vitro (Ames test, HPRT test, chromosome aberration test) or in vivo (chromosome aberration test, mouse micronucleus test).

Cetrorelix acetate induced polyploidy in CHL-Chinese hamster lung fibroblasts, but not in V79-Chinese hamster lung fibroblasts, cultured peripheral human lymphocytes or in an in vitro micronucleus test in the CHL-cell line. Treatment with 0.46 mg/kg cetrorelix acetate for 4 weeks resulted in complete infertility in female rats which was reversed 8 weeks after cessation of treatment. Pregnancy (see CONTRAINDICATIONS ) Cetrorelix acetate is contraindicated in pregnant women.

When administered to rats for the first seven days of pregnancy, cetrorelix acetate did not affect the development of the implanted conceptus at doses up to 38 mcg/kg (approximately 1 times the recommended human therapeutic dose based on body surface area). However, a dose of 139 mcg/kg (approximately 4 times the human dose) resulted in a resorption rate and a post-implantation loss of 100%. When administered from day 6 to near term to pregnant rats and rabbits, very early resorptions and total implantation losses were seen in rats at doses from 4.6 mcg/kg (0.2 times the human dose) and in rabbits at doses from 6.8 mcg/kg (0.4 times the human dose).

In animals that maintained their pregnancy, there was no increase in the incidence of fetal abnormalities. The fetal resorption observed in animals is a logical consequence of the alteration in hormonal levels effected by the antigonadotrophic properties of cetrorelix acetate, which could result in fetal loss in humans as well. Therefore, this drug should not be used in pregnant women.

Nursing Mothers It is not known whether cetrorelix acetate is excreted in human milk. Because many drugs are excreted in human milk, and because the effects of cetrorelix acetate on lactation and/or the breast-fed child have not been determined, cetrorelix acetate should not be used by nursing mothers. Geriatric Use Cetrorelix acetate is not intended to be used in subjects aged 65 and over.

🍼 Nursing Mothers 48 words ▾

Nursing Mothers It is not known whether cetrorelix acetate is excreted in human milk. Because many drugs are excreted in human milk, and because the effects of cetrorelix acetate on lactation and/or the breast-fed child have not been determined, cetrorelix acetate should not be used by nursing mothers.

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics The pharmacokinetic parameters of single and multiple doses of cetrorelix acetate in adult healthy female subjects are summarized in Table 1 . Table 1: Pharmacokinetic parameters of cetrorelix acetate following 3 mg single or 0.25 mg single and multiple (daily for 14 days) subcutaneous (sc) administration t max Time to reach observed maximum plasma concentration t 1/2 Elimination half-life C max Maximum plasma concentration; multiple dose C ss, max AUC Area under the curve; single dose AUC 0-inf , multiple dose AUCt CL Total plasma clearance Vz Volume of distribution Geometric mean (95% CI ln ), * arithmetic mean, † median (min-max) ‡ Based on iv administration (n=6, separate study 0013) Single dose 3 mg Single dose 0.25 mg Multiple dose 0.25 mg No. of subjects 12 12 12 t max † [h] 1.5 (0.5-2) 1.0 (0.5-1.5) 1.0 (0.5-2) t 1/2 † [h] 62.8 (38.2-108) 5.0 (2.4-48.8) 20.6 (4.1-179.3) C max [ng/mL] 28.5 (22.5-36.2) 4.97 (4.17-5.92) 6.42 (5.18-7.96) AUC [ng·h/mL] 536 (451-636) 31.4 (23.4-42.0) 44.5 (36.7-54.2) CL * [mL/min·kg] 1.28 ‡ Vz * [L/kg] 1.16 ‡ Absorption Cetrorelix acetate is rapidly absorbed following subcutaneous injection, maximal plasma concentrations being achieved approximately one to two hours after administration.

The mean absolute bioavailability of cetrorelix acetate following subcutaneous administration to healthy female subjects is 85%. Distribution The volume of distribution of cetrorelix acetate following a single intravenous dose of 3 mg is about 1 L/kg. In vitro protein binding to human plasma is 86%.

Cetrorelix acetate concentrations in follicular fluid and plasma were similar on the day of oocyte pick-up in patients undergoing controlled ovarian stimulation. Following subcutaneous administration of cetrorelix acetate 0.25 mg and 3 mg, plasma concentrations of cetrorelix acetate were below or in the range of the lower limit of quantitation on the day of oocyte pick-up and embryo transfer. Metabolism After subcutaneous administration of 10 mg cetrorelix acetate to females and males, cetrorelix acetate and small amounts of (1-9), (1-7), (1-6), and (1-4) peptides were found in bile samples over 24 hours.

In in vitro studies, cetrorelix acetate was stable against phase I- and phase II-metabolism. Cetrorelix acetate was transformed by peptidases, and the (1-4) peptide was the predominant metabolite. Excretion Following subcutaneous administration of 10 mg cetrorelix acetate to males and females, only unchanged cetrorelix acetate was detected in urine.

In 24 hours, cetrorelix acetate and small amounts of the (1-9), (1-7), (1-6), and (1-4) peptides were found in bile samples. 2-4% of the dose was eliminated in the urine as unchanged cetrorelix acetate, while 5-10% was eliminated as cetrorelix acetate and the four metabolites in bile. Therefore, only 7-14% of the total dose was recovered as unchanged cetrorelix acetate and metabolites in urine and bile up to 24 hours.

The remaining portion of the dose may not have been recovered since bile and urine were not collected for a longer period of time. Special Populations Pharmacokinetic investigations have not been performed either in subjects with impaired renal or liver function, or in the elderly, or in children (see PRECAUTIONS ). Pharmacokinetic differences in different races have not been determined.

There is no evidence of differences in pharmacokinetic parameters for cetrorelix acetate between healthy subjects and patients undergoing controlled ovarian stimulation.

🔬 Clinical Studies ~3 min read ▾

Clinical Studies Seven hundred thirty two (732) patients were treated with cetrorelix acetate in five (two Phase 2 dose-finding and three Phase 3) clinical trials. The clinical trial population consisted of Caucasians (95.5%) and Black, Asian, Arabian and others (4.5%). Women were between 19 and 40 years of age (mean: 32).

The studies excluded subjects with polycystic ovary syndrome (PCOS), subjects with low or no ovarian reserve, and subjects with stage III-IV endometriosis. Two dose regimens were investigated in these clinical trials, either a single dose per treatment cycle or multiple dosing. In the Phase 2 studies, a single dose of 3 mg was established as the minimal effective dose for the inhibition of premature LH surges with a protection period of at least 4 days.

When cetrorelix acetate is administered in a multidose regimen, 0.25 mg was established as the minimal effective dose. The extent and duration of LH-suppression is dose dependent. In the Phase 3 program, efficacy of the single 3 mg dose regimen of cetrorelix acetate and the multiple 0.25 mg dose regimen of cetrorelix acetate was established separately in two adequate and well controlled clinical studies utilizing active comparators.

A third non-comparative clinical study evaluated only the multiple 0.25 mg dose regimen of cetrorelix acetate. The ovarian stimulation treatment with recombinant FSH or human menopausal gonadotropin (hMG) was initiated on day 2 or 3 of a normal menstrual cycle. The dose of gonadotropins was administered according to the individual patient's disposition and response.

In the single dose regimen study, cetrorelix acetate 3 mg was administered on the day of controlled ovarian stimulation when adequate estradiol levels (400 pg/mL) were obtained, usually on day 7 (range day 5-12). If hCG was not given within 4 days of the 3 mg dose of cetrorelix acetate, then 0.25 mg of cetrorelix acetate was administered daily beginning 96 hours after the 3 mg injection until and including the day of hCG administration. In the two multiple dose regimen studies, cetrorelix acetate 0.25 mg was started on day 5 or 6 of COS.

Both gonadotropins and cetrorelix acetate were continued daily (multiple dose regimen) until the injection of human chorionic gonadotropin (hCG). Oocyte pick-up (OPU) followed by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) as well as embryo transfer (ET) were subsequently performed. The results for cetrorelix acetate are summarized below in Table 2 .

Table 2: Results of Phase 3 Clinical Studies with Cetrorelix Acetate 3 mg in a single dose (sd) regimen and 0.25 mg in a multiple dose (md) regimen * Progesterone † Following initiation of cetrorelix acetate therapy ‡ Morning values § Median with 5th – 95th percentiles ¶ Mean ± standard deviation Parameter Cetrorelix Acetate 3 mg (sd, active comparator study) Cetrorelix Acetate 0.25 mg (md, active comparator study) Cetrorelix Acetate 0.25 mg (md, non-comparative study) No. of subjects 115 159 303 hCG administered [%] 98.3 96.2

96.0Oocyte pick-up [%] 98.3 94.3

93.1LH-surge [%] (LH ≥ 10 U/L and P * ≥ 1 ng/mL) † 0.0 1.9

1.0Serum E 2 [pg/mL] at day hCG ‡ , § 1125 (470-2952) 1064 (341-2531) 1185 (311-3676) Serum LH [U/L] at day hCG ‡ , § 1.0 (0.5-2.5) 1.5 (0.5-7.6) 1.1 (0.5-3.5) No. of follicles ≥ 11 mm at day hCG ¶ 11.2±5.5 10.8±5.2 10.4±4.5 No. of oocytes: IVF ¶ 9.2±5.2 7.6±4.3 8.5±5.1 ICSI ¶ 10.0±4.2 10.1±5.6 9.3±5.9 Fertilization rate: IVF ¶ 0.48±0.33 0.62±0.26 0.60±0.26 ICSI ¶ 0.66±0.29 0.63±0.29 0.61±0.25 No. of embryos transferred ¶ 2.6±0.9 2.1±0.6 2.7±1.0 Clinical pregnancy rate [%] per attempt 22.6 20.8 19.8 per subject with ET 26.3 24.1

23.3In addition to IVF and ICSI, one pregnancy was obtained after intrauterine insemination. In the five Phase 2 and Phase 3 clinical trials, 184 pregnancies have been reported out of a total of 732 patients (including 21 pregnancies following the replacement of frozen-thawed embryos). In the 3 mg regimen, 9 patients rec… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 96 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in animals have not been performed with cetrorelix acetate. Cetrorelix acetate was not genotoxic in vitro (Ames test, HPRT test, chromosome aberration test) or in vivo (chromosome aberration test, mouse micronucleus test). Cetrorelix acetate induced polyploidy in CHL-Chinese hamster lung fibroblasts, but not in V79-Chinese hamster lung fibroblasts, cultured peripheral human lymphocytes or in an in vitro micronucleus test in the CHL-cell line.

Treatment with 0.46 mg/kg cetrorelix acetate for 4 weeks resulted in complete infertility in female rats which was reversed 8 weeks after cessation of treatment.

📄 Patient Package Insert ~3 min read ▾

Patient Leaflet Cetrorelix (SE-troe-REL-ix) Acetate for Injection 0.25 mg Active ingredient: cetrorelix acetate Summary Cetrorelix acetate blocks the effects of a natural hormone, called gonadotropin-releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization.

Cetrorelix acetate blocks such undesirable premature ovulation. Uses Cetrorelix Acetate for Injection is used to prevent premature ovulation during controlled ovarian stimulation. General Cautions Do not use Cetrorelix Acetate for Injection if you have kidney disease are allergic to cetrorelix acetate, mannitol or exogenous peptide hormones (medicines similar to Cetrorelix Acetate for Injection) or are pregnant, or think that you might be pregnant, or if you are breast-feeding.

Consult your doctor before taking Cetrorelix Acetate for Injection if you have had severe allergic reactions. Proper Use Ovarian stimulation therapy is started on cycle Day 2 or 3. Cetrorelix Acetate for Injection 0.25 mg is injected under the skin once daily, as directed by your physician.

When an ultrasound examination shows that you are ready, another drug (hCG) is injected to induce ovulation. How should you use Cetrorelix Acetate for Injection? You may self-inject Cetrorelix Acetate for Injection after special instruction from your doctor.

To fully benefit from Cetrorelix Acetate for Injection, please read carefully and follow the instructions given below, unless your doctor advises you otherwise. Cetrorelix Acetate for Injection is for injection under the skin of the lower abdominal area, preferably around, but staying at least one inch away from the belly button. Choose a different injection site each day to minimize local irritation.

Dissolve Cetrorelix Acetate for Injection powder only with the water contained in the prefilled syringe. Do not use a Cetrorelix Acetate for Injection solution if it contains particles or if it is not clear. Before you inject Cetrorelix Acetate for Injection yourself, please read the following instructions carefully: Directions for using Cetrorelix Acetate for Injection 0.25 mg with the enclosed needles and prefilled syringe: 1.

Wash your hands thoroughly with soap and water. 2. On a clean flat surface, lay out everything you need (one vial of powder, one prefilled syringe, one injection needle with a yellow mark, and one injection needle with a grey mark).

3. Flip off the plastic cover of the vial. Wipe the aluminum ring and the rubber stopper with an alcohol swab.

4. Take the injection needle with the yellow mark and remove the wrapping. Take the prefilled syringe and remove the cover.

Twist the needle on the syringe and remove the cover of the needle. 5. Push the needle through the center of the rubber stopper of the vial.

Inject the water into the vial by slowly pushing down on the plunger of the syringe. 6. Leave the syringe in the vial.

While carefully holding the syringe and vial, swirl gently to mix the powder and water together. When it is mixed, it will look clear and have no particles in it. Do not shake or you will create bubbles in your medicine.

7. Draw the total contents of the vial into the syringe. If liquid is left in the vial, invert the vial, pull back the needle until the opening of the needle is just inside the stopper.

If you look from the side through the gap in the stopper, you can control the movement of the needle and the liquid. It is important to withdraw the entire contents of the vial. 8.

Detach the syringe from the needle and lay down the syringe. Take the injection needle with the grey mark and remove its wrapping. Twist the needle on the syringe and remove the cover of the needle.

9. Invert the syringe and push the plunger until all air bubbles have been pushed out. Do not touch the needle or allow the ne… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL – Cetrorelix Acetate for Injection 0.25 mg Vial Label NDC 71288- 556 -02 Rx Only Cetrorelix Acetate for Injection 0.25 mg per vial For Subcutaneous Use Only Protect from light. Store refrigerated 2° to 8°C (36° to 46°F). Sterile Single-Dose Vial - Discard unused portion PRINCIPAL DISPLAY PANEL – Cetrorelix Acetate for Injection 0.25 mg Vial Label

PRINCIPAL DISPLAY PANEL – Cetrorelix Acetate for Injection 1 mL Diluent Syringe Label NDC 71288- 557 -81 Rx Only Sterile Water for Injection, USP 1 mL 1 mL Single-Dose Prefilled Syringe Discard unused portion pH 5 to 8 PRINCIPAL DISPLAY PANEL – Cetrorelix Acetate for Injection 1 mL Diluent Syringe Label

PRINCIPAL DISPLAY PANEL – Cetrorelix Acetate for Injection Kit Tray Label NDC 71288- 558 -90 Single-Dose Kit Rx Only Cetrorelix Acetate for Injection 0.25 mg per vial Sterile - For Subcutaneous Use Only Store the packaged tray in the outer carton. Store refrigerated 2° to 8°C (36° to 46°F). Discard unused portion PRINCIPAL DISPLAY PANEL – Cetrorelix Acetate for Injection Kit Tray Label

PRINCIPAL DISPLAY PANEL – Cetrorelix Acetate for Injection Kit Carton NDC 71288- 558 -90 Single-Dose Kit Rx Only Cetrorelix Acetate for Injection 0.25 mg per vial Sterile- For Subcutaneous Use Only Store refrigerated 2° to 8°C (36° to 46°F). PRINCIPAL DISPLAY PANEL – Cetrorelix Acetate for Injection Kit 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 Cetrorelix Acetate — the ingredient across all brands.

Top reported reactions

Ovarian Hyperstimulation Syndrome135
Premature Ovulation40
Abortion Spontaneous39
Ascites28
Abdominal Distension27
Abdominal Pain26
Nausea24

Age at onset

Neonate8
Adolescent5
Adult100
Elderly1

Reporter sex

617 reports

Serious outcomes

Life-threatening24
Death7
Disabling6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 94 23
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.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

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NDC identity (package / product / labeler codes) ✓ Available
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Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
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Orange Book / therapeutic-equivalence data ✓ Available
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Meitheal Pharmaceuticals Inc. has reported a marketing end date of 2027-04-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Meitheal Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 71288-0555-86 · Meitheal 71288-0563-84 · 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.