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EMBLAVEO aztreonam and avibactam 127 mg/mL; 42.3 mg/mL Powder, For Solution — NDC 00074-3878-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

EMBLAVEO aztreonam and avibactam 127 mg/mL; 42.3 mg/mL Powder, For Solution — NDC 0074-3878-10 (Billing 00074-3878-10)

by AbbVie Inc. · 10 VIAL, SINGLE-DOSE in 1 CARTON / 12 mL in 1 VIAL, SINGLE-DOSE

This is a package of EMBLAVEO aztreonam and avibactam 127 mg/mL; 42.3 mg/mL Powder, For Solution from AbbVie Inc., marketed since Feb 2025 and currently FDA-listed. It is this product's only package size.

NDC 00074-3878-10
🏷️ FDA NDC (as labeled) 0074-3878-10 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 0074-3878-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0074 labeler · 3878 product · 10 package
Package marketed since
Feb 7, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0074387810 3
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0074-3878-10
Product NDC 0074-3878
11-digit billing NDC 00074387810
NCPDP billing unit EA — each (per item)
RxCUI 2705355, 2705360
UNII G2B4VE5GH8, 7352665165
Application # NDA217906
SPL Set ID be1a6c99-d4b3-46d7-9e99-6e5f9fab556a
Established class (EPC) Monobactam Antibacterial; beta Lactamase Inhibitor
Mechanism of action beta Lactamase Inhibitors
Chemical class Monobactams
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-07
Route INTRAVENOUS
Dosage form POWDER, FOR SOLUTION
Substance AZTREONAM; AVIBACTAM

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

GCN Seq No 087258
GCN 57117
HICL code 050285
Ingredient (HICL) Aztreonam/Avibactam Sodium
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1P
Therapeutic class — specific (HIC3) Betalactams
AHFS code 08:12.07.16
AHFS class Monobactam Antibiotics
FDB label name EMBLAVEO 2 GM VIAL
FDB brand name Emblaveo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087258
  • GCN: 57117
  • HICL (First Databank): 050285
  • AHFS class code: 08:12.07.16
  • RxCUI (RxNorm): 2705355
Why two NDCs? The FDA registers this code as 0074-3878-10 — 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 → 00074-3878-10. 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 Monobactam Antibacterial class.

Pharmacologic class Monobactam Antibacterial
Drug family (ATC) Monobactams
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 EMBLAVEO 2 GM VIAL Ingredient Aztreonam/Avibactam Sodium
📖 What it is MedlinePlus · NLM

Aztreonam and avibactam injection is used to treat serious intra-abdominal infections (infections in the organs and areas surrounding the organs in the abdominal cavity). Aztreonam is in a class of medications called monobactam antibiotics. It works by killing bacteria. Avibactam is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from breaking down aztreonam. Antibiotics such as aztreonam and avibactam injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infec...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is used together with metronidazole to treat complicated infections inside the abdomen in adults 18 and older who have limited or no other treatment options. It targets certain...
  • A healthcare professional gives it through a vein, over about 3 hours per dose, every 6, 8 or 12 hours depending on your kidneys. Treatment usually lasts 5 to 14 days. Your care te...
  • How is Emblaveo given, and for how long?
  • The most common are liver test changes, anemia, diarrhea, low potassium and fever. Most are picked up through monitoring. Tell your team about rash, trouble breathing, skin blister...
📖 Read our full Avibactam / Aztreonam guide →

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 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.
Medicare Part B allowsASP · J0458 $1.773 / J0458 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)0074-3878-10
11-digit billing NDC00074-3878-10
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ0458
DescriptorINJECTION, AZTREONAM/AVIBACTAM, 7.5 MG/2.5 MG (10 MG)
Billing units / pkg200 units
How the units are derivedThis package is 10 EA; the HCPCS unit is 7.5 MG, so one package = 200 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00074-3878-10 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 CARTON / 12 mL in 1 VIAL, SINGLE-DOSE 2025-02-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Emblaveo 127 mg/mL; 42.3 mg/mLthis 00074-3878-10 AbbVie 10 vials — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2025
First FDA approval
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 7, 2025 RLD RS ⏳ ~6.3 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 7112592 — drug substance (U-4147)
US 8969566 — drug substance
US 8835455 — drug product
US 9695122 — drug substance
US 7612087 — drug product
US 8471025 — drug substance
US 9284314 — drug substance
Exclusivity NP
Exclusivity GAIN
2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (7)
PatentTypeUse codeExpires
US 7112592 ↗ Drug substance U-4147 Jan 7, 2026
US 8969566 ↗ Drug substance — Jun 15, 2032
US 8835455 ↗ Drug product — Oct 8, 2030
US 9695122 ↗ Drug substance — Jun 15, 2032
US 7612087 ↗ Drug product — Nov 12, 2026
US 8471025 ↗ Drug substance — Aug 12, 2031
US 9284314 ↗ Drug substance — Jun 15, 2032
FDA exclusivity
CodeWhat it grantsExpires
NPNew ProductFeb 7, 2028
GAINQualified Infectious Disease Product (+5-year)Feb 7, 2033
Common questions
Is there a generic version of EMBLAVEO 2 GM VIAL?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for EMBLAVEO 2 GM VIAL. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2033 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

🧪 Avoiding an ingredient? See Avibactam / Aztreonam inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 99.1 mg / 1 mL UNII 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.

1 inactive ingredient listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerAbbVie Inc.
Application holderABBVIE INC
FDA applicationNDA217906 (NDA)
Labeler code00074
First marketedFeb 2025
Product typeHuman Prescription Drug
Portfolio129 products on file

More NDCs from AbbVie Inc. labeler code 00074

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens .

Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 )

1.1Complicated Intra-abdominal Infections EMBLAVEO, in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae , Klebsiella oxytoca , Enterobacter cloacae complex , Citrobacter freundii complex , and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO [ see Clinical Studies ( 14.1 )] .

1.2Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended Dosage in Adults based on Estimated Creatinine Clearance (C Lcr ) ( 2.1 , 2.2 ) Estimated C Lcr (mL/min) a Dose b Infusion Time Dosing Interval c Loading Maintenance Greater than 50 mL/min EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) EMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams) 3 hours Every 6 hours Greater than 30 to less than or equal to 50 mL/min EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) EMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams) 3 hours Every 6 hours Greater than 15 to less than or equal to 30 mL/min EMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams) EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 3 hours Every 8 hours Less than or equal to 15 mL/min, including on hemodialysis d EMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams) EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 3 hours Every 12 hours a Calculated using the Cockcroft-Gault formula. b Aztreonam-avibactam is a combination product in a fixed 3:1 ratio.

A single loading dose is followed by maintenance doses beginning at the next dosing interval. c Dosing interval is calculated from the start of one infusion to the start of the subsequent infusion. d Both aztreonam and avibactam are removed by hemodialysis; thus, administer EMBLAVEO after hemodialysis, on hemodialysis days. For treatment of cIAI, administer metronidazole concurrently. ( 2.1 , 2.2 ) Recommended duration of treatment for cIAI: 5 to 14 days.

( 2.1 , 2.2 )

2.1Recommended Dosage in Adults with Estimated Creatinine Clearance G reater than 50 mL/min Table 1 shows the recommended dosage to be administered by intravenous (IV) infusion over 3 hours in adults with estimated creatinine clearance (CLcr) greater than 50 mL/min. Table 1. Recommended dosage for adults with estimated CLcr greater than 50 mL/min a Type of Infection Recommended Doses for EMBLAVEO (aztreonam and avibactam) b Dosing Interval c Treatment duration Complicated intra-abdominal infections (cIAI) d Loading EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) Every 6 hours 5 to 14 days Maintenance EMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams) a Calculated using the Cockcroft-Gault formula. b Aztreonam-avibactam is a combination product in a fixed 3:1 ratio.

A single loading dose is followed by maintenance doses beginning at the next dosing interval. c Dosing interval is calculated from the start of one infusion to the start of the subsequent infusion. d For treatment of cIAI, administer metronidazole concurrently.

2.2Recommended Dosage in Adults with Estimated Creatinine Clearance L ess than or E qual to 50 mL/min Table 2 shows the recommended dosage to be administered by intravenous (IV) infusion over 3 hours in adults with estimated creatinine clearance (CLcr) less than or equal to 50 mL/min. In patients with renal impairment, close monitoring of estimated CLcr is advised. In some patients, the CLcr estimated from serum creatinine can change quickly, especially early in the course of treatment for the infection.

For treatment of cIAI, administer metronidazole concurrently. Table 2. Recommended dosage for adults with estimated CLcr less than or equal to 50 mL/min Estimated CLcr (mL/min) a Recommended Dose for EMBLAVEO (aztreonam and avibactam) b,c Dosing Interval d Greater than 30 to less than or equal to 50 mL/min Loading EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) Every 6 hours Maintenance EMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams) Greater than 15 to less than or equal to 30 mL/min Loading EMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams) Every 8 hours Maintenance EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) Less than or equal to 15, including on hemodialysis e Loading EMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams) Every 12 hours Maintenance EMBLAVEO 0.9 g (aztreonam 0.675 gram… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 78 words ▾

3 DOSAGE FORMS AND STRENGTHS EMBLAVEO (aztreonam and avibactam) for injection is supplied as a white to slightly yellow sterile lyophilized powder for reconstitution in a single-dose, sterile, clear glass vial containing: 2 g aztreonam and avibactam (1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 grams of avibactam sodium)). EMBLAVEO (aztreonam and avibactam) for injection is a lyophilized powder in a single-dose vial containing 2 g (1.5 grams aztreonam and 0.5 grams avibactam). ( 3 )

⛔ Contraindications 39 words ▾

4 CONTRAINDICATIONS EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam) [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam). ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Hypersensitivity reactions were noted in patients treated with EMBLAVEO including rash, flushing, and bronchospasm. In case of hypersensitivity reactions, immediately discontinue EMBLAVEO and initiate appropriate medications and/or supportive care. ( 5.1 ) Serious Skin Disorders: Cases of toxic epidermal necrolysis have been reported in association with aztreonam (a component of EMBLAVEO) in patients undergoing bone marrow transplant with multiple risk factors.

Discontinue EMBLAVEO if serious skin reaction occurs. ( 5.2 ) Hepatic Adverse Reactions: Elevations in hepatic transaminases have been observed during treatment with EMBLAVEO. If transaminase elevations are noted, consider discontinuation of EMBLAVEO, if clinically indicated, and monitor the patient for resolution of any pertinent clinical and laboratory findings.

( 5.3 ) Clostridioides Difficile -Associated Diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including EMBLAVEO. Evaluate if diarrhea occurs. ( 5.4 ) 5.

1 Hypersensitivity Reactions Hypersensitivity reactions were noted in patients treated with EMBLAVEO, including rash, flushing, and bronchospasm [see Adverse Reactions ( 6.1 )]. Prior to treatment, it should be established if the patient has a history of hypersensitivity reactions to components of EMBLAVEO (aztreonam and avibactam). In case of hypersensitivity reactions, immediately discontinue EMBLAVEO and initiate appropriate medications and/or supportive care.

5. 2 Serious Skin Disorders Cases of toxic epidermal necrolysis have been reported in association with aztreonam (a component of EMBLAVEO) in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis. Discontinue EMBLAVEO if a serious skin reaction occurs.

5. 3 Hepatic Adverse Reactions Elevations in hepatic transaminases have been observed during treatment with EMBLAVEO [see Adverse Reactions ( 6.1 )]. Monitoring of liver-related laboratory tests is recommended while on treatment, particularly in patients with baseline liver comorbidities or on concomitant hepatotoxic medications.

If transaminase elevations are noted, consider discontinuing EMBLAVEO, if clinically indicated, and monitor the patient for resolution of any pertinent clinical and laboratory findings. 5. 4 Clostridioides Difficile -Associated Diarrhea Clostridioides difficile - associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs, including EMBLAVEO, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial drugs alters the normal flora of the colon and may permit overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial drugs. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued.

Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile , and institute surgical evaluation as clinically indicated.

5.5Development of Drug-Resistant Bacteria Prescribing EMBLAVEO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Indications and Usage ( 1.2 )].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Serious Skin Disorders [see Warnings and Precautions ( 5.2 )] Hepatic Adverse Reactions [see Warnings and Precautions ( 5.3 )] Clostridioides Difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring at an incidence of greater than 5% were hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adult Patients Three clinical trials, Trial 1, Trial 2, and Trial 3, underly the EMBLAVEO clinical development program. Trial 1 was a randomized, comparative trial conducted in patients with cIAI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) (not an approved indication for EMBLAVEO), while Trials 2 and 3 were smaller, noncomparative trials conducted in patients with cIAI as well as other serious infections caused by gram negative pathogens expressing metallo-beta-lactamases.

The safety data from Trial 1 are summarized below. In Trial 1, EMBLAVEO was evaluated in a comparative clinical trial in patients with cIAI or HABP/VABP; note that EMBLAVEO is not approved for the treatment of HABP/VABP. Trial 1 evaluated 275 patients treated with EMBLAVEO and 137 patients treated with comparator (meropenem +/- colistin); 203 EMBLAVEO-treated patients had a diagnosis of cIAI while 72 EMBLAVEO-treated patients had a diagnosis of HABP/VABP (not an approved indication for EMBLAVEO).

Patients received treatment with EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) or comparator for 5 to 14 days. Patients randomized to EMBLAVEO received a loading dose of aztreonam and avibactam administered by intravenous infusion over 30 minutes immediately followed by an extended loading dose infused over 3 hours, followed by maintenance doses infused over 3 hours every 6 hours based on the participant’s creatinine clearance. Patients with cIAI randomized to EMBLAVEO also received metronidazole 500 mg administered by intravenous infusion over 60 minutes every 8 hours.

The median age of patients in Trial 1 treated with EMBLAVEO was 58 years, ranging between 18 and 87 years old. Patients treated with EMBLAVEO were predominantly male (66%) and White (59%). Approximately 40% (22% of cIAI and 89% of HABP/VABP; not an approved indication) of patients treated with EMBLAVEO had an APACHE II score greater than 10 at baseline.

Death occurred in 6.9% (19/275) of patients who received EMBLAVEO and in 8% (11/137) of patients who received comparator. In patients with cIAI, death occurred in 3.0% (6/203) of patients treated with EMBLAVEO and 2.9% (3/103) in patients treated with comparator. Overall, 3.6% (10/275) of the patients who received EMBLAVEO discontinued treatment due to an adverse reaction, compared with 3.6% (5/137) of patients treated with comparator.

Common adverse reactions occurring in greater than 5% of patients are noted in the table below. Table 5: Adverse Reactions Occurring in > 5% of Patients in the EMBLAVEO Treatment Arm in Trial 1 Adverse Reactions EMBLAVEO ± Metronidazole (N=275) n (%) Meropenem ± Colistin (N=137) n (%) Hepatic adverse reactions* 40 (14.5) 16 (11.7) Anemia** 22 (8.0) 7 (5.1) Diarrhea 16 (5.8) 5 (3.6) Hypokalemia 16 (5.8) 4 (2.9) Pyrexia*** 16 (5.8) 7 (5.1) *Includes AR terms alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 54 words ▾

7 DRUG INTERACTIONS

7.1OAT 1 and 3 Transport Inhibitors Concomitant use of organic anion transporter (OAT) 1 and OAT 3 transporter inhibitors (e.g., probenecid) with EMBLAVEO is not recommended. There is insufficient information to characterize the effect of concomitant use of OAT 1/3 transport inhibitors with EMBLAVEO [see Clinical Pharmacology ( 12.3 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no data on the effects of EMBLAVEO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from case reports over several decades with aztreonam and over approximately a decade with avibactam have not identified a drug-associated risk of major birth defects, miscarriage or other maternal or fetal outcomes. Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam revealed no evidence of embryotoxicity, fetotoxicity, or fetal malformations at doses 2.7- and 3.6-fold greater, respectively, than the maximum recommended human dose (MRHD) for adults of 6.5 g per day.

In a peri/postnatal development (PPND) study in rats, no aztreonam-induced changes in any maternal, fetal, or neonatal parameters were observed at a dose 2.7-fold greater than the MRHD. Avibactam Avibactam administered to pregnant rats was not associated with fetal malformations at doses 6 times the MRHD of 2.17 g per day. In pregnant rabbits, avibactam administered in doses greater than or equal to 5 times the MRHD was associated with increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies.

In a rat PPND study, there were no effects on pup growth and viability at doses up to 8 times the avibactam MRHD. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups with renal pelvic dilatation persisting into adulthood (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam up to 1800 and 1200 mg/kg, respectively, revealed no evidence of embryotoxicity or fetotoxicity or fetal malformations.

These doses, based on body surface area, are 2.7- and 3.6-fold greater than the MRHD for adults of 6.5 g per day. A peri/postnatal study in rats revealed no drug-induced changes in any maternal, fetal, or neonatal parameters. The highest dose used in this study, 1800 mg/kg/day, is 2.7 times the MRHD based on body surface area comparison.

Avibactam Avibactam did not produce fetal malformations in pregnant rats or rabbits. In the rat, intravenous studies with 0, 250, 500 and 1000 mg/kg/day of avibactam during gestation days 6-17 showed no embryo-fetal toxicity at doses up to 1000 mg/kg/day, approximately 6 times the MRHD (2.17 g/day) based on exposure (AUC). Pregnant rabbits administered intravenous avibactam on gestation days 6-19 at 0, 100, 300 and 1000 mg/kg/day showed no effects on embryo-fetal development at a dose of 100 mg/kg, twice the MRHD based on AUC comparison.

At doses greater than or equal to 300 mg/kg/day (5 times the MRHD based on AUC comparison), increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies were observed. In a rat pre-and post-natal study at up to 825 mg/kg/day intravenously (8 times the MRHD based on AUC), there were no effects on pup growth and viability. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups that was not associated with pathological changes to renal parenchyma or renal function, with renal pelvic dilatation persisting after female weaning pups became adults.

8.2Lactation Risk Summary Aztreonam is present in human milk at concentrations that are less than 1% of those determined in simultaneously obtained maternal serum. There are no data on the presence of avibactam in… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no data on the effects of EMBLAVEO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from case reports over several decades with aztreonam and over approximately a decade with avibactam have not identified a drug-associated risk of major birth defects, miscarriage or other maternal or fetal outcomes. Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam revealed no evidence of embryotoxicity, fetotoxicity, or fetal malformations at doses 2.7- and 3.6-fold greater, respectively, than the maximum recommended human dose (MRHD) for adults of 6.5 g per day.

In a peri/postnatal development (PPND) study in rats, no aztreonam-induced changes in any maternal, fetal, or neonatal parameters were observed at a dose 2.7-fold greater than the MRHD. Avibactam Avibactam administered to pregnant rats was not associated with fetal malformations at doses 6 times the MRHD of 2.17 g per day. In pregnant rabbits, avibactam administered in doses greater than or equal to 5 times the MRHD was associated with increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies.

In a rat PPND study, there were no effects on pup growth and viability at doses up to 8 times the avibactam MRHD. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups with renal pelvic dilatation persisting into adulthood (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam up to 1800 and 1200 mg/kg, respectively, revealed no evidence of embryotoxicity or fetotoxicity or fetal malformations.

These doses, based on body surface area, are 2.7- and 3.6-fold greater than the MRHD for adults of 6.5 g per day. A peri/postnatal study in rats revealed no drug-induced changes in any maternal, fetal, or neonatal parameters. The highest dose used in this study, 1800 mg/kg/day, is 2.7 times the MRHD based on body surface area comparison.

Avibactam Avibactam did not produce fetal malformations in pregnant rats or rabbits. In the rat, intravenous studies with 0, 250, 500 and 1000 mg/kg/day of avibactam during gestation days 6-17 showed no embryo-fetal toxicity at doses up to 1000 mg/kg/day, approximately 6 times the MRHD (2.17 g/day) based on exposure (AUC). Pregnant rabbits administered intravenous avibactam on gestation days 6-19 at 0, 100, 300 and 1000 mg/kg/day showed no effects on embryo-fetal development at a dose of 100 mg/kg, twice the MRHD based on AUC comparison.

At doses greater than or equal to 300 mg/kg/day (5 times the MRHD based on AUC comparison), increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies were observed. In a rat pre-and post-natal study at up to 825 mg/kg/day intravenously (8 times the MRHD based on AUC), there were no effects on pup growth and viability. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups that was not associated with pathological changes to renal parenchyma or renal function, with renal pelvic dilatation persisting after female weaning pups became adults.

🧒 Pediatric Use 22 words ▾

8.4Pediatric Use The safety and effectiveness of EMBLAVEO in pediatric patients less than 18 years of age have not been established.

🧓 Geriatric Use 201 words ▾

8.5Geriatric Use In Trials 1, 2, and 3, there were 103 patients in the EMBLAVEO treatment arm 65 years of age and older. Of these patients, 60 (58%) were between 65-74 years of age and 43 (42%) patients were 75 years of age and older. In comparison, there were 202 patients in the EMBLAVEO treatment arm less than 65 years of age.

Clinical studies of EMBLAVEO did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Aztreonam and avibactam (components of EMBLAVEO) are known to be substantially excreted by the kidney, and the risk of adverse reactions to aztreonam and avibactam (components of EMBLAVEO) may be greater in patients with impaired renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. No dosage adjustment is required in elderly patients based on age; the dose should be selected based on renal function [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 48 words ▾

10 OVERDOSAGE There is no information on the clinical signs and symptoms associated with an overdose of EMBLAVEO. Aztreonam and avibactam can be partially removed by hemodialysis [see Clinical Pharmacology ( 12.3 )] . No clinical information is available on the use of hemodialysis to treat EMBLAVEO overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action EMBLAVEO is an antibacterial drug [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics As with other beta-lactam antimicrobial drugs, the time that unbound plasma concentrations of aztreonam exceed the EMBLAVEO minimum inhibitory concentration (MIC) against the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with Enterobacterales. The time above a threshold concentration has been determined to be the parameter that best predicts the efficacy of avibactam in combination with aztreonam in in vitro and in vivo nonclinical models.

Cardiac Electrophysiology Avibactam does not prolong the QTc interval to any clinically significant extent at a dose 3 times the maximum approved EMBLAVEO recommended avibactam loading dose. Aztreonam QT prolongation evaluations have not been conducted or reported in literature.

12.3Pharmacokinetics Following single or multiple dosing, the C max and AUC of both aztreonam and avibactam (components of EMBLAVEO) increase in an approximate dose-proportional manner over a dose range of 500 mg to 2000 mg aztreonam (0.25 to 1 times the approved maximum recommended loading dose) and of 50 mg to 2000 mg avibactam (0.07 to 3 times the approved maximum recommended loading dose). Aztreonam and avibactam (components of EMBLAVEO) pharmacokinetic properties are summarized in Table 6. There is minimal accumulation of aztreonam and avibactam following multiple intravenous 3-hour infusions of EMBLAVEO every 6 hours in patients with normal renal function.

Table 6: Pharmacokinetic (PK) Properties of Components of EMBLAVEO (Aztreonam and Avibactam) PK Parameter Aztreonam Avibactam C max, ss (mg/L) a,b, c 54.46 ± 17.22 11.29 ±

3.89AUC 0-24, ss (mg•h/L) a,b,c 841.22 ± 317.59 165.7 ±

65.63Distribution Binding to human plasma proteins 38 % 8 % Volume of distribution (Vss) c 21.4 ± 23 L 37.8 ± 73 L Elimination Clearance (CL) c 10.2 ± 22 L/hr 18 ± 39 L/hr Mean terminal half-life (t 1/2 ) c 2.03 ± 0.69 hrs 2.04 ± 0.52 hrs Metabolism Metabolic pathways Aztreonam is minimally metabolized. No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes). Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [ 14 C]-avibactam Excretion Major route of elimination Renal excretion: tubular secretion and glomerular filtration % of dose excreted in urine, unchanged 64.2 % to 75.9 % 83.8 % to 100 % % of dose excreted in feces, changed and unchanged Approximately 12 % < 0.25 % C max, ss =maximum plasma concentration at steady-state; AUC 0-24, ss =area under the plasma concentration-time curve from time zero up to 24 hrs at steady state; Vss = volume of distribution at steady state; mean = arithmetic mean; SD = standard deviation. a 2000 mg aztreonam + 670 mg avibactam IV infusion over 3 hours then 1500 mg aztreonam + 500 mg avibactam IV infusion over 3 hours every 6 hours. b There is no clinically significant PK differences (as measured by AUC and Cmax) between healthy adults and adults with cIAI (normal renal function). c mean ± SD reported based on PK data from 97 adults with cIAI Specific Populations No clinically significant differences in the pharmacokinetics of aztreonam or avibactam were observed based on age (range: 18-89 years), sex (62.1% male), race (61.9% White, 27.7% Asian, and 3.4% Black), or BMI (10.4 to 62.5 kg/m 2 ).

Patients with Renal Impairment The disposition of aztreonam and avibactam were evaluated in non-infected subjects with CLcr >80 mL/min (as measured by Cockcroft-Gault method, n=6) administered the recommended general maintenance dosing regimen and with CLcr 32 to 37 mL/min (n=5) administered the recommended adjusted maintenance dosing regimen for CLcr >15 to ≤ 30 mL/min. Aztreonam AUC 24 and C max at steady state is approximately 21% and 24% lower in the subjects with CLcr 32 to 37 mL/min compared to the CLcr >80 mL/m… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action EMBLAVEO is an antibacterial drug [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 77 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING EMBLAVEO 2 grams (aztreonam and avibactam) for injection is supplied as a sterile powder in single-dose, clear glass vial containing: 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 grams of avibactam sodium). Vials are supplied as individual vial (NDC 0074-3878-01) and in cartons containing 10 vials (NDC 0074-3878-10). EMBLAVEO vials should be stored at 2°C to 8°C (36°F to 46°F).

Protect from light. Store in carton until time of use.

📋 Description 188 words ▾

11 DESCRIPTION EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid.

Its molecular weight is 435.43 g/mol. The empirical formula is C 13 H 17 N 5 O 8 S 2 . Figure 1 .

Chemical structure of aztreonam . Avibactam Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate.

Its molecular weight is 287.23 g/mol. The empirical formula is C 7 H 10 N 3 O 6 SNa. Figure 2.

Chemical structure of avibactam sodium . EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial.

Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial. Figure 1.

Chemical structure of aztreonam. Figure 2. Chemical structure of avibactam sodium.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Serious Allergic Reactions Advise patients, their families, or caregivers that allergic reactions, including serious allergic reactions, could occur that require immediate treatment. Ask them about any previous hypersensitivity reactions to EMBLAVEO, other beta-lactams, or other allergens [see Warnings and Precautions ( 5.1 )] . Serious Skin Reactions Advise patients about the signs and symptoms of serious skin manifestations such as sudden onset of a severe rash or blistering or peeling skin, possibly accompanied by a high fever or joint pain (these may be signs of more serious medical conditions such as toxic epidermal necrolysis) [see Warnings and Precautions ( 5.2 )] .

Potentially Serious Diarrhea Advise patients, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, tell them to contact his or her healthcare provider [see Warnings and Precautions ( 5.4 )] .

Antibacterial Resistance Patients should be counseled that antibacterial drugs including EMBLAVEO should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When EMBLAVEO is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by EMBLAVEO or other antibacterial drugs in the future [ see Warnings and Precautions ( 5.5 ) ] . Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2026 AbbVie.

All rights reserved. EMBLAVEO and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company. PAA248062-R3

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Following single or multiple dosing, the C max and AUC of both aztreonam and avibactam (components of EMBLAVEO) increase in an approximate dose-proportional manner over a dose range of 500 mg to 2000 mg aztreonam (0.25 to 1 times the approved maximum recommended loading dose) and of 50 mg to 2000 mg avibactam (0.07 to 3 times the approved maximum recommended loading dose). Aztreonam and avibactam (components of EMBLAVEO) pharmacokinetic properties are summarized in Table 6. There is minimal accumulation of aztreonam and avibactam following multiple intravenous 3-hour infusions of EMBLAVEO every 6 hours in patients with normal renal function.

Table 6: Pharmacokinetic (PK) Properties of Components of EMBLAVEO (Aztreonam and Avibactam) PK Parameter Aztreonam Avibactam C max, ss (mg/L) a,b, c 54.46 ± 17.22 11.29 ±

3.89AUC 0-24, ss (mg•h/L) a,b,c 841.22 ± 317.59 165.7 ±

65.63Distribution Binding to human plasma proteins 38 % 8 % Volume of distribution (Vss) c 21.4 ± 23 L 37.8 ± 73 L Elimination Clearance (CL) c 10.2 ± 22 L/hr 18 ± 39 L/hr Mean terminal half-life (t 1/2 ) c 2.03 ± 0.69 hrs 2.04 ± 0.52 hrs Metabolism Metabolic pathways Aztreonam is minimally metabolized. No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes). Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [ 14 C]-avibactam Excretion Major route of elimination Renal excretion: tubular secretion and glomerular filtration % of dose excreted in urine, unchanged 64.2 % to 75.9 % 83.8 % to 100 % % of dose excreted in feces, changed and unchanged Approximately 12 % < 0.25 % C max, ss =maximum plasma concentration at steady-state; AUC 0-24, ss =area under the plasma concentration-time curve from time zero up to 24 hrs at steady state; Vss = volume of distribution at steady state; mean = arithmetic mean; SD = standard deviation. a 2000 mg aztreonam + 670 mg avibactam IV infusion over 3 hours then 1500 mg aztreonam + 500 mg avibactam IV infusion over 3 hours every 6 hours. b There is no clinically significant PK differences (as measured by AUC and Cmax) between healthy adults and adults with cIAI (normal renal function). c mean ± SD reported based on PK data from 97 adults with cIAI Specific Populations No clinically significant differences in the pharmacokinetics of aztreonam or avibactam were observed based on age (range: 18-89 years), sex (62.1% male), race (61.9% White, 27.7% Asian, and 3.4% Black), or BMI (10.4 to 62.5 kg/m 2 ).

Patients with Renal Impairment The disposition of aztreonam and avibactam were evaluated in non-infected subjects with CLcr >80 mL/min (as measured by Cockcroft-Gault method, n=6) administered the recommended general maintenance dosing regimen and with CLcr 32 to 37 mL/min (n=5) administered the recommended adjusted maintenance dosing regimen for CLcr >15 to ≤ 30 mL/min. Aztreonam AUC 24 and C max at steady state is approximately 21% and 24% lower in the subjects with CLcr 32 to 37 mL/min compared to the CLcr >80 mL/min group.

The avibactam AUC24 and Cmax at steady state are approximately 24% and 2% higher in the subjects with CLcr 32 to 37 mL/min, compared to the CLcr >80 mL/min group. Dosage adjustment for EMBLAVEO in patients with CLcr ≤ 50 mL/min is recommended [see Dosage and Administration ( 2.2 )] . Patients with Hepatic Impairment EMBLAVEO has not been studied in patients with hepatic impairment.

As aztreonam and avibactam do not appear to undergo significant hepatic metabolism, the systemic clearance of either active substance is not expected to be significantly altered by hepatic impairment. Dosage adjustments are not considered necessary for EMBLAVEO in patients with impaired hepatic function. Geriatric Patients (Greater than or equal to 65 years) Mean elimination half-life of both aztreonam and avibactam is increased, and plasma clearance decreased in the elderly, consistent with age-related reduction in renal cle… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 115 words ▾

12.2Pharmacodynamics As with other beta-lactam antimicrobial drugs, the time that unbound plasma concentrations of aztreonam exceed the EMBLAVEO minimum inhibitory concentration (MIC) against the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with Enterobacterales. The time above a threshold concentration has been determined to be the parameter that best predicts the efficacy of avibactam in combination with aztreonam in in vitro and in vivo nonclinical models.

Cardiac Electrophysiology Avibactam does not prolong the QTc interval to any clinically significant extent at a dose 3 times the maximum approved EMBLAVEO recommended avibactam loading dose. Aztreonam QT prolongation evaluations have not been conducted or reported in literature.

🔬 Clinical Studies 102 words ▾

14 CLINICAL STUDIES

14.1Complicated Intra-abdominal Infections The determination of efficacy of EMBLAVEO was supported in part by the previous findings of the efficacy and safety of aztreonam for the treatment of cIAI. The contribution of avibactam to EMBLAVEO was primarily established in vitro and in animal models of infection [see Clinical Pharmacology ( 12.4 )] . EMBLAVEO was studied in one randomized, active-controlled, multicenter trial (Trial 1, NCT03329092) in patients with cIAI or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) (not an approved indication for EMBLAVEO).

The trial was not designed with any formal hypotheses for inferential testing against the active comparator.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Aztreonam Carcinogenicity studies with aztreonam have not been conducted using an intravenous route of administration. A 104-week rat inhalation toxicology study to assess the carcinogenic potential of aztreonam demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized aztreonam for up to 4 hours per day.

Peak plasma levels of aztreonam averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level. Avibactam Carcinogenicity studies with avibactam have not been conducted. Mutagenesis Aztreonam Genetic toxicology studies performed with aztreonam in vitro (Ames test, mouse lymphoma forward mutation assay, gene conversion assay, chromosome aberration assay in human lymphocytes) and in vivo (mouse bone marrow cytogenetic assay) did not reveal evidence of mutagenic or clastogenic potential.

Avibactam Avibactam was negative for genotoxicity in the Ames assay, unscheduled DNA synthesis, chromosomal aberration assay, and a rat micronucleus study. Impairment of Fertility Aztreonam A two-generation reproduction study in rats at daily doses of 150, 600, or 2400 mg/kg/day given prior to and during gestation and lactation, revealed no evidence of impaired fertility. Based on body surface area, the high dose is 3.6-fold greater than the maximum recommended human dose (MRHD) for adults of 6.5 g per day.

There was a slightly reduced survival rate during the lactation period in the offspring of rats that received the highest dose, but not in offspring of rats that received lower doses of aztreonam. Avibactam Avibactam had no adverse effects on fertility of male and female rats given up to 1g/kg/day (approximately 4.5-fold higher than the MRHD of 2.17 g/day on a body surface area basis). There was a dose-related increase in the percentage of pre-and post-implantation loss relative to controls, resulting in a lower mean litter size at doses of 0.5 g/kg/day (approximately 2 times the MRHD on a body surface area basis) and greater with intravenous administration to female rats beginning 2 weeks prior to mating.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Aztreonam Carcinogenicity studies with aztreonam have not been conducted using an intravenous route of administration. A 104-week rat inhalation toxicology study to assess the carcinogenic potential of aztreonam demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized aztreonam for up to 4 hours per day.

Peak plasma levels of aztreonam averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level. Avibactam Carcinogenicity studies with avibactam have not been conducted. Mutagenesis Aztreonam Genetic toxicology studies performed with aztreonam in vitro (Ames test, mouse lymphoma forward mutation assay, gene conversion assay, chromosome aberration assay in human lymphocytes) and in vivo (mouse bone marrow cytogenetic assay) did not reveal evidence of mutagenic or clastogenic potential.

Avibactam Avibactam was negative for genotoxicity in the Ames assay, unscheduled DNA synthesis, chromosomal aberration assay, and a rat micronucleus study. Impairment of Fertility Aztreonam A two-generation reproduction study in rats at daily doses of 150, 600, or 2400 mg/kg/day given prior to and during gestation and lactation, revealed no evidence of impaired fertility. Based on body surface area, the high dose is 3.6-fold greater than the maximum recommended human dose (MRHD) for adults of 6.5 g per day.

There was a slightly reduced survival rate during the lactation period in the offspring of rats that received the highest dose, but not in offspring of rats that received lower doses of aztreonam. Avibactam Avibactam had no adverse effects on fertility of male and female rats given up to 1g/kg/day (approximately 4.5-fold higher than the MRHD of 2.17 g/day on a body surface area basis). There was a dose-related increase in the percentage of pre-and post-implantation loss relative to controls, resulting in a lower mean litter size at doses of 0.5 g/kg/day (approximately 2 times the MRHD on a body surface area basis) and greater with intravenous administration to female rats beginning 2 weeks prior to mating.

📄 Package Label / Principal Display Panel 90 words ▾

Principal Display Panel NDC 0074-3878-10 Rx Only 10 single-dose vials Emblaveo ® 2g per vial* (aztreonam and avibactam) for injection *Aztreonam 1.5 grams and avibactam 0.5 grams (equivalent to 0.542 grams of avibactam sodium). Single-Dose Vial. Discard Unused Portion MUST BE RECONSTITUTED THEN DILUTED.

FOR INTRAVENOUS INFUSION. NDC 0074-3878-10 Rx Only 10 single-dose vials Emblaveo® 2g per vial* (aztreonam and avibactam) for injection *Aztreonam 1.5 grams and avibactam 0.5 grams (equivalent to 0.542 grams of avibactam sodium). Single-Dose Vial.

Discard Unused Portion MUST BE RECONSTITUTED THEN DILUTED. FOR INTRAVENOUS INFUSION.

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

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Emblaveo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Emblaveo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$9K
Claims incl. refills
11
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$819.37
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

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: this package is listed as actively marketed, with no marketing end date reported by AbbVie Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AbbVie 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.
Do I need a prescription for this product?
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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0458 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
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.
← 00074-3799-02 · AbbVie 00074-3956-46 · AbbVie →
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.