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Cetrorelix Kit — NDC 0480-5795-08 (Billing 00480-5795-08)

by Teva Pharmaceuticals, Inc. · 1 TRAY in 1 CARTON / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 SYRINGE

This is a package of Cetrorelix Kit from Teva Pharmaceuticals, Inc., no longer marketed (first marketed Dec 2023), no longer in the FDA NDC Directory, this package's marketing ended Jun 2026. It is this product's only package size.

NDC 00480-5795-08
🏷️ FDA NDC (as labeled) 0480-5795-08 billing pads the labeler segment with a zero
Rx only Generic Discontinued Non-controlled ⚠ On shortage ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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NDC database record

One package, one record: these facts belong to NDC 0480-5795-08 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0480 labeler · 5795 product · 08 package
Package marketed since
Dec 14, 2023
Package marketing ended
Jun 30, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 0480579508 7
FDA record last changed
Jul 2, 2026
⚠️
Active FDA shortage. Cetrorelix Acetate Injection is currently reported in shortage by the FDA. Shortage details →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0480-5795-08
Product NDC 0480-5795
11-digit billing NDC 00480579508
NCPDP billing unit EA — each (per item)
RxCUI 283402
Application # ANDA215737
SPL Set ID f91c971b-89d7-4306-966d-8ecc1afc16d1
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2023-12-14
Marketing end 2026-06-30
Route SUBCUTANEOUS
Dosage form KIT

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
  • RxCUI (RxNorm): 283402
Why two NDCs? The FDA registers this code as 0480-5795-08 — a 4-4-2 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 labeler segment → 00480-5795-08. 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 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
00480-5795-08 You're viewing this Main listing 1 TRAY in 1 CARTON / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE * 1 mL in 1 SYRINGE 2023-12-14 Jun 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetrotide 44087-1225-01 EMD 1 kit $306.057 AP FDA listed —
Cetrorelixthis 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 Acetate 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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

LabelerTeva Pharmaceuticals, Inc.
Application holderTEVA PHARMACEUTICALS INC
FDA applicationANDA215737 (ANDA)
Labeler code00480
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio166 products on file

More NDCs from Teva Pharmaceuticals, Inc. labeler code 00480

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 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 pre-filled 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 pre-filled 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 41 words ▾

CONTRAINDICATIONS Cetrorelix acetate for injection 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 33 words ▾

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

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The safety of cetrorelix acetate for injection 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 for injection 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 for injection treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in cetrorelix acetate for injection 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 for Injection 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 postmarketing 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 for injection.

Congenital Anomalies Clinical follow-up studies of 316 newborns of women administered cetrorelix acetate for injection 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 for injection is unknown. Multiple factors, genetic and others (including, but not limited to ICSI, IVF, gonadotropins, and progesterone) make causal attribution difficult to study.

To report SUSPECTED ADVERSE REACTIONS contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 15 words ▾

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

🤰 Pregnancy 187 words ▾

Pregnancy (see CONTRAINDICATIONS ) Cetrorelix acetate for injection 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 time 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 for injection, which could result in fetal loss in humans as well.

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

🧓 Geriatric Use 18 words ▾

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

🆘 Overdosage 44 words ▾

OVERDOSAGE There have been no reports of overdosage with cetrorelix acetate for injection 0.25 mg or 3 mg in humans. Single doses up to 120 mg cetrorelix acetate for injection 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 for injection 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 for injection, which is consistent with an antagonist effect. The effects of cetrorelix acetate for injection on LH and FSH are reversible after discontinuation of treatment. In women, cetrorelix acetate for injection 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 for injection, duration of action of at least 4 days has been established. A dose of cetrorelix acetate for injection 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 for injection in adult healthy female subjects are summarized in Table 1. Table 1: Pharmacokinetic parameters of Cetrorelix Acetate for Injection 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 AUC t 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 ‡ V z * [l/kg] 1.16 ‡ Absorption Cetrorelix acetate for injection 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 for injection following subcutaneous administration to healthy female subjects is 85%. Distribution The volume of distribution of cetrorelix acetate for injection following a single intravenous dose of 3 mg is about 1 l/kg. In vitro protein binding to human plasma is 86%.

Cetrorelix acetate for injection 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 for injection, 0.25 mg and 3 mg, plasma concentrations of cetrorelix 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 for injection to females and males, cetrorelix acetate for injection 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 for injection was stable against phase I- and phase II-metabolism. Cetrorelix acetate for inje… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 111 words ▾

HOW SUPPLIED Cetrorelix Acetate for Injection 0.25 mg is available in a carton of one packaged tray (NDC 0480-5795-08). Each packaged tray contains: one glass vial containing 0.26 – 0.27 mg cetrorelix acetate (corresponding to 0.25 mg cetrorelix), one pre-filled glass syringe with 1 mL of Sterile Water for Injection, USP, one 20 gauge needle (yellow) and one 27 gauge needle (grey). Storage Store Cetrorelix Acetate for Injection 0.25 mg refrigerated, 2-8°C (36-46°F).

Store the packaged tray in the outer carton in order to protect from light. Rx only Manufactured In Spain By: GP Pharm, S.A. Barcelona, Spain (ESP) – 08777 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.

C 6/2024

📦 Storage and Handling 49 words ▾

Storage Store Cetrorelix Acetate for Injection 0.25 mg refrigerated, 2-8°C (36-46°F). Store the packaged tray in the outer carton in order to protect from light. Rx only Manufactured In Spain By: GP Pharm, S.A. Barcelona, Spain (ESP) – 08777 Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 6/2024

📋 Description 148 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 (Ac-D-Nal 1 - D -Cpa 2 - D -Pal 3 -Ser 4 -Tyr 5 - D -Cit 6 -Leu 7 -Arg 8 -Pro 9 - D -Ala 10 -NH 2 ) 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 1.0 mL pre-filled 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 76 words ▾

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

If cetrorelix acetate for injection 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 postmarketing 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 for injection (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 for injection is not advised in women with severe allergic conditions. Information for Patients Prior to therapy with cetrorelix acetate for injection, 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 for injection should not be prescribed if a patient is pregnant. If cetrorelix acetate for injection 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 for injection 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 for injection 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 for injection. 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 for injection 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 time 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 for injection, 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 for injection is excreted in human milk. Because many drugs are excreted in human milk, and because the effects of cetrorelix acetate for injection on lactation and/or the breast-fed child have not been determined, cetrorelix acetate for injection… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 54 words ▾

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

🧬 Pharmacokinetics ~3 min read ▾

Pharmacokinetics The pharmacokinetic parameters of single and multiple doses of cetrorelix acetate for injection in adult healthy female subjects are summarized in Table 1. Table 1: Pharmacokinetic parameters of Cetrorelix Acetate for Injection 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 AUC t 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 ‡ V z * [l/kg] 1.16 ‡ Absorption Cetrorelix acetate for injection 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 for injection following subcutaneous administration to healthy female subjects is 85%. Distribution The volume of distribution of cetrorelix acetate for injection following a single intravenous dose of 3 mg is about 1 l/kg. In vitro protein binding to human plasma is 86%.

Cetrorelix acetate for injection 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 for injection, 0.25 mg and 3 mg, plasma concentrations of cetrorelix 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 for injection to females and males, cetrorelix acetate for injection 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 for injection was stable against phase I- and phase II-metabolism. Cetrorelix acetate for injection was transformed by peptidases, and the (1-4) peptide was the predominant metabolite. Excretion Following subcutaneous administration of 10 mg cetrorelix to males and females, only unchanged cetrorelix was detected in urine.

In 24 hours, cetrorelix 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, while 5-10% was eliminated as cetrorelix and the four metabolites in bile. Therefore, only 7-14% of the total dose was recovered as unchanged cetrorelix 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 for injection 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 for injection 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 for injection 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 for injection and the multiple 0.25 mg dose regimen of cetrorelix acetate for injection 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 for injection. 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 for injection 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 for injection, then 0.25 mg of cetrorelix acetate for injection 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 for injection 0.25 mg was started on day 5 or 6 of COS.

Both gonadotropins and cetrorelix acetate for injection 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 for injection are summarized below in Table 2.

Table 2: Results of Phase 3 Clinical Studies with Cetrorelix Acetate for Injection 3 mg in a single dose (sd) regimen and 0.25 mg in a multiple dose (md) regimen * Progesterone † Following initiation of cetrorelix acetate for injection therapy ‡ Morning values § Median with 5th – 95th percentiles ¶ Mean ± standard deviation Parameter Cetrorelix Acetate for Injection 3 mg (sd, active comparator study) Cetrorelix Acetate for Injection 0.25 mg (md, active comparator study) Cetrorelix Acetate for Injection 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 ¶ ICSI ¶ 9.2±5.2 10.0±4.2 7.6±4.3 10.1±5.6 8.5±5.1 9.3±5.9 Fertilization rate: IVF ¶ ICSI ¶ 0.48±0.33 0.66±0.29 0.62±0.26 0.63±0.29 0.60±0.26 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 per subject with ET 22.6 26.3 20.8 24.1 19.8

23.3In addition to IVF and ICSI, one pregnancy was obtained after intrauterine insemination. In the f… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 95 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.

📄 Package Label / Principal Display Panel 187 words ▾

NDC 0480-5795-08 Cetrorelix Acetate for Injection 0.25 mg Sterile – for subcutaneous use only Store refrigerated, 2-8°C (36-46°F). One carton contains one packaged tray which contains: 1 vial with lyophilized powder for reconstitution 1 pre-filled syringe with diluent 1 20-gauge needle 1 27-gauge needle Rx only carton label

NDC 0480-5795-08 Rx only Cetrorelix Acetate for Injection 0.25 mg STERILE – FOR SUBCUTANEOUS USE ONLY Contains: one vial with lyophilized powder for reconstitution, one pre-filled syringe with diluent, one 20-gauge needle and one 27-gauge needle. Store the packaged tray in the outer carton. Store refrigerated, 2-8°C (36-46°F).

Manufactured In Spain By: GP Pharm, S.A., Barcelona, Spain (ESP) - 08777 Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054 Rev. A 7/2023 clamshell card label

NDC 0480-3583-01 Rx only Cetrorelix Acetate for Injection, 0.25 mg STERILE – FOR SUBCUTANEOUS USE ONLY Store vial protected from light. Store refrigerated, 2-8ºC (36-46ºF). Manufactured In Spain For: Teva Pharmaceuticals, Parsippany, NJ 07054 ET-CETR601-US-04 Rev. A 7/2023 vial label

NDC 0480-3584-21 Rx only 1 mL Prefilled Sterile Water for Injection, USP Mfd. In The Netherlands For: Teva Pharmaceuticals, Parsippany, NJ 07054 Rev. B 3/2024 1

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

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