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Teflaro ceftaroline fosamil 400 mg/20mL Powder, For Solution — NDC 0456-0400-10 (Billing 00456-0400-10)

by Allergan, Inc. · 10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE

This is a package of Teflaro ceftaroline fosamil 400 mg/20mL Powder, For Solution from Allergan, Inc., marketed since Oct 2010 and currently FDA-listed. It is this product's only package size.

NDC 00456-0400-10
🏷️ FDA NDC (as labeled) 0456-0400-10 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

NDC database record

One package, one record: these facts belong to NDC 0456-0400-10 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0456 labeler · 0400 product · 10 package
Package marketed since
Oct 29, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0304560400103
Medicaid fills, this package
143 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0456-0400-10
Product NDC 0456-0400
11-digit billing NDC 00456040010
NCPDP billing unit EA — each (per item)
RxCUI 1040008, 1040012, 1040014, 1040016
UNII 7P6FQA5D21
UPC 0304560400103
Application # NDA200327
SPL Set ID 3ecde48b-75a2-4beb-9999-369f3f61bb8a
Established class (EPC) Cephalosporin Antibacterial
Chemical class Cephalosporins
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-10-29
Route INTRAVENOUS
Dosage form POWDER, FOR SOLUTION
Substance CEFTAROLINE FOSAMIL
TE code (Orange Book) AP · RLD · RS

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

GPI-14 02500030102120
GPI class Teflaro
GCN Seq No 066810
GCN 29213
HICL code 037243
Ingredient (HICL) Ceftaroline Fosamil Acetate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W9
Therapeutic class — intermediate (HIC2) Antibiotics (Continued 1)
HIC3 code W9G
Therapeutic class — specific (HIC3) Cephalosporin Antibiotics - 5Th Generation
AHFS code 08:12.06.20
AHFS class 5Th Generation Cephalosporin Antibiotics
FDB label name TEFLARO 400 MG VIAL
FDB brand name Teflaro
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066810
  • GCN: 29213
  • GPI-14 (Medi-Span): 02500030102120
  • HICL (First Databank): 037243
  • AHFS class code: 08:12.06.20
  • RxCUI (RxNorm): 1040008
Why two NDCs? The FDA registers this code as 0456-0400-10 — 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 → 00456-0400-10. 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 Other cephalosporins and penems class.

Drug family (ATC) Other cephalosporins and penems
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 TEFLARO 400 MG VIAL Ingredient Ceftaroline Fosamil Acetate
📖 What it is MedlinePlus · NLM

Ceftaroline injection is used to treat some types of infections caused by bacteria. Ceftaroline is in a class of medications called cephalosporin antibiotics. It works by killing bacteria. Antibiotics such as ceftaroline injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is an IV antibiotic for bacterial skin infections and for pneumonia you caught outside the hospital. It only works on bacteria, so it will not help a cold or flu.
  • A healthcare professional gives it through a vein, usually every 8 or 12 hours as an infusion lasting up to an hour. Your prescriber decides how long you need it based on your infe...
  • The most common are diarrhea, nausea and rash. Children may also have vomiting or fever. Some people get irritation in the vein where the IV is.
  • Get help for trouble breathing, swelling, hives or a severe skin reaction. Also report watery or bloody diarrhea, which can appear even weeks after treatment. Tell your team about...
📖 Read our full Ceftaroline Injection 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 $269.48 $53,895.94 / 200 ml
Medicare drug plans payPart D · Q2 2026 $270.49 $54,097.02 / 200 ml
Medicare Part B allowsASP · J0712 $4.390 / J0712 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)0456-0400-10
11-digit billing NDC00456-0400-10
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ0712
DescriptorInjection, ceftaroline fosamil, 10 mg
Billing units / pkg400 units
How the units are derivedThis package is 1; the HCPCS unit is 10 MG, so one package = 400 billing units.
Medicare Part B spend (2026 (Q1))$80,030 · 122 claims · $655.99 per claim (all NDCs under J0712)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
00456-0400-10 You're viewing this Main listing 10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE 2010-10-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Teflaro 400 mg/20mLthis 00456-0400-10 Allergan, 10 vials — AP FDA listed —
Ceftaroline Fosamil 400 mg/20mL 60505-6124-01 Apotex 10 vials — AP FDA listed —
Ceftaroline Fosamil 400 mg/20mL 60505-4946-01 Apotex 10 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2010
First FDA approval
Oct 2010
📍
2026
Currently FDA-listed
16 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Oct 29, 2010 AP TE-rated RLD RS ⏳ ~4.4 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 8247400 — method of use (U-282)
US 8247400 — method of use (U-282)
US 9629861 — drug product
US 9629861 — drug product
2010 2012 2014 2016 2018 2020 2022 2024 2026 2028 2030
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 (4)
PatentTypeUse codeExpires
US 8247400 ↗ Method of use U-282 Feb 10, 2031
US 8247400 ↗ Method of use U-282 Feb 10, 2031
US 9629861 ↗ Drug product — Sep 21, 2030
US 9629861 ↗ Drug product — Sep 21, 2030
Common questions
Is there a generic version of TEFLARO 400 MG VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for TEFLARO 400 MG VIAL. See the alternatives section for substitutable, lower-cost products.
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.

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

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA200327 (NDA)
Labeler code00456
First marketedOct 2010
Product typeHuman Prescription Drug
Portfolio188 products on file

More NDCs from Allergan, Inc. labeler code 00456

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 👥 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 ~2 min read ▾

1. INDICATIONS AND USAGE Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ( 1.1 ) Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.3 )

1.1Acute Bacterial Skin and Skin Structure Infections Teflaro is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Escherichia coli , Klebsiella pneumoniae , and Klebsiella oxytoca [see Dosage and Administration ( 2.2 ) and Use in Specific Populations ( 8.4 )] .

1.2Community-Acquired Bacterial Pneumonia Teflaro is indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

1.3Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. 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 Dosage of Teflaro by Indication in Adult and Pediatric Patients ( 2.1 , 2.2 ) Indication Age Range Dosage Infusion Time Duration Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to < 18 years (> 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to < 18 years (≤ 33kg) 12 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 2 months to < 2 years 8 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 0* to < 2 months 6 mg/kg every 8 hours 30 to 60 minutes 5 to 14 days *Gestational age 34 weeks and older and postnatal age 12 days and older Indication Age Range Dosage Infusion Time Duration Community Acquired Bacterial Pneumonia (CABP) 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 7 days ≥2 years to < 18 years (> 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to < 18 years (≤ 33kg) 12 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 2 months to < 2 years 8 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days Dosage adjustment is required in adult patients with creatinine clearance (CrCl) < 50 mL/min and in End-stage Renal Disease (ESRD) including hemodialysis ( 2.3 ) There is insufficient information to recommend a dosage regimen for pediatric patients with CrCL < 50 mL/min/1.73 m 2 ( 2.3 )

2.1Recommended Dosage in Adult Patients The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 5 to 60 minutes in patients ≥ 18 years of age. The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress. The recommended dosage and administration by infection is described in Table 1.

Table 1: Dosage of Teflaro by Indication in Adults In dication Dosage Frequency Infusion Time Recommended Duration of Treatment Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 600 mg Every 12 hours 5 to 60 minutes 5-14 days Community-Acquired Bacterial Pneumonia (CABP) 600 mg Every 12 hours 5 to 60 minutes 5-7 days

2.2Recomme n ded Dosage in Pediatric Patients The recommended dosage of Teflaro in pediatric patients is based on the age and weight of the child. The duration of therapy should be guided by the severity, site of infection and the patient’s clinical and bacteriological progress. Pediatric Patients 2 Months of Age and Older For pediatric patients 2 months of age and older, Teflaro is administered every 8 hours by intravenous infusion over 5 to 60 minutes.

Teflaro dosing regimen is dependent on the type of infection (ABSSSI, CABP). See dosing Table 2 below. Table 2: Dosage of Teflaro by Indication in Pediatric Patients 2 Months of Age and Older Indication Age Range Dosage and Frequency Infusion time Recommended Duration of Treatment Acute Bacterial Skin and Skin Structure Infections (ABSSSI) OR Community-Acquired Bacterial Pneumonia (CABP) 2 months to < 2 years 8 mg/kg every 8 hours 5 to 60 minutes 5-14 days > 2 years to < 18 years ( < 33 kg) 12 mg/kg every 8 hours > 2 years to < 18 years (> 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours Pediatric Patients Less Than 2 Months of Age Teflaro is administered every 8 hours by intravenous infusion over 30 to 60 minutes for patients less than 2 months of age.

Teflaro dosing regimen is only recommended for patients with ABSSSI. See dosing Table 3 below. Concentrations of Teflaro in the cerebrospinal fluid have not been evaluated [see Use in Specific Populations ( 8.4 )] .

There is no information for dosing Teflaro in infants less than 34 weeks gestational age and less than 12 days postnatal age. Table 3: Dosage of Teflaro in Pediatric Patients less Than 2 Months of Age Indication Age Range Dosage and Frequency Infusion time Recommended Duration of Treatment Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 0* to < 2 months 6 mg/kg every 8 hours 30 to 60 minut… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 86 words ▾

3. DOSAGE FORMS AND STRENGTHS For Injection: Teflaro is supplied as 600 mg or 400 mg of pale yellowish-white to light yellow sterile ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate) powder in single-dose, 20 mL clear glass vials. The powder is constituted and further diluted for intravenous injection.

For Injection: 600 mg or 400 mg of sterile ceftaroline fosamil powder in single-dose 20 mL vials. The powder is constituted and further diluted for intravenous injection. ( 3 )

⛔ Contraindications 41 words ▾

4. CONTRAINDICATIONS Teflaro is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has been reported with ceftaroline. Known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including Teflaro. If a hypersensitivity reaction occurs, discontinue Teflaro.

( 5.1 ) Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Teflaro. Evaluate if diarrhea occurs. ( 5.2 ) Neurological adverse reactions have been reported in patients treated with cephalosporins, including Teflaro.

If neurological adverse reactions occur, consider discontinuing Teflaro or making appropriate dosage adjustments in patients with renal impairment. ( 2.3 , 5.3 ) Direct Coombs’ test seroconversion has been reported with Teflaro. If anemia develops during or after therapy, a diagnostic workup for drug-induced hemolytic anemia should be performed and consideration given to discontinuation of Teflaro.

( 5.4 )

5.1Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with Teflaro is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been clearly established.

If an allergic reaction to Teflaro occurs, discontinue Teflaro and institute appropriate treatment and supportive measures.

5.2Clostridioides difficile - Associated Diarrhea Clostridioides difficile -associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including Teflaro, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents 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 antibiotic use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions ( 6.1 )].

5.3Neurological Adverse Reactions Neurological adverse reactions have been reported during postmarketing surveillance in patients treated with cephalosporins, including Teflaro. These reactions include encephalopathy and seizures [see Adverse Reactions ( 6.2 )] . Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment.

The neurological adverse reactions were reversible and resolved after discontinuation of Teflaro or after hemodialysis. If neurological adverse reactions associated with Teflaro therapy occur, consider discontinuing Teflaro or making appropriate dosage adjustments in patients with renal impairment [see Dosage and Administration ( 2.3 )] .

5.4Direct Coombs ’ Test Seroconversion Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of adult patients receiving Teflaro and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled adult Phase 3 trials. In the pooled adult Phase 3 CABP trials, 51/520 (9.8%) of Teflaro-treated patients compared to 24/534 (4.5%) of ceftriaxone-treated patients seroconverted from a negative to a positive direc… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Clostridioides difficile -Associated diarrhea [see Warnings and Precautions ( 5.2 )] Neurological Adverse Reactions [see Warnings and Precautions ( 5.3 )] Direct Coombs’ Test Seroconversion [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring in >2% of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash.

Additional adverse reactions that occurred in ≥3% of pediatric patients include vomiting and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-678-1605 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 clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice. Adult Patients Teflaro was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1300 adult patients treated with Teflaro (600 mg administered by IV over 1 hour every 12h) and 1297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days.

The median age of patients treated with Teflaro was 54 years, ranging between 18 and 99 years old. Patients treated with Teflaro were predominantly male (63%) and Caucasian (82%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In the four pooled adult Phase 3 clinical trials, serious adverse reactions (SARs) occurred in 98/1300 (7.5%) of patients receiving Teflaro and 100/1297 (7.7%) of patients receiving comparator drugs.

Treatment discontinuation due to adverse reactions occurred in 35/1300 (2.7%) of patients receiving Teflaro and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse reactions leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the Teflaro group and 0.5% in comparator group. Most Common Adverse Reactions No adverse reactions occurred in greater than 5% of adult patients receiving Teflaro. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled adult phase 3 clinical trials were diarrhea, nausea, and rash.

Table 6 lists adverse reactions occurring in ≥ 2% of patients receiving Teflaro in the pooled adult Phase 3 clinical trials. Table 6: Adverse Reactions Occurring in ≥ 2% of Patients Receiving Teflaro in the Pooled Adult Phase 3 Clinical Trials Adverse Reactions Pooled Phase 3 Clinical Trials (four trials, two in ABSSSI and two in CABP) Teflaro (N=1300) Pooled Comparators a (N=1297) Gastrointestinal D isorders Diarrhea 5 % 3 % Nausea 4 % 4 % Constipation 2 % 2 % Vomiting 2 % 2 % Laboratory Investigations Increased transaminases 2% 3 % Metabolism and N utrition disorders Hypokalemia 2 % 3 % Skin and S ubcutaneous T issue D isorders Rash 3% 2% Vascular D isorders Phlebitis 2% 1% a Comparators included vancomycin 1 gram IV every 12h plus aztreonam 1 gram IV every 12h in the Phase 3 ABSSSI trials, and ceftriaxone 1 gram IV every 24h in the Phase 3 CABP trials.

Other Adverse Reactions Observed During Clinical Trials of Teflaro Following is a list of additional adverse reactions reported by the 1740 adult patients who received Teflaro in any clinical trial with incidences less than 2%. Blood and lymphatic system disorders - Anemia, Eosinophilia, Neutropenia, Thrombocytopenia Cardiac disorders - Bradycardia, Palpitations Gastrointestinal disorders - Abdominal pain General disorders and administration site conditions - Pyrexia Hepatobiliary disorders - Hepatitis Immune system disorders - Hypersensitivity, Anaphylaxis Infections and infestations - Clostridioides difficil… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no adequate studies with Teflaro in pregnant women that informed any drug associated risks. The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population.

In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed to Teflaro at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation. In rabbits exposed to Teflaro during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity. Data Animal Data Developmental toxicity studies performed with ceftaroline fosamil in rats at IV doses up to 300 mg/kg demonstrated no maternal toxicity and no effects on the fetus.

A separate toxicokinetic study showed that ceftaroline exposure in rats (based on AUC) at this dose level was approximately 4 times the exposure in humans given 600 mg every 12 hours. There were no drug-induced malformations in the offspring of rabbits given IV doses of 25, 50, and 100 mg/kg, despite maternal toxicity. Signs of maternal toxicity appeared secondary to the sensitivity of the rabbit gastrointestinal system to broad-spectrum antibacterials and included changes in fecal output in all groups and dose-related reductions in body weight gain and food consumption at > 50 mg/kg; these were associated with an increase in spontaneous abortion at 50 and 100 mg/kg.

The highest dose was also associated with maternal moribundity and mortality. An increased incidence of a common rabbit skeletal variation, angulated hyoid alae, was also observed at the maternally toxic doses of 50 and 100 mg/kg. A separate toxicokinetic study showed that ceftaroline exposure in rabbits (based on AUC) was approximately 0.4 times the exposure in humans given 600 mg every 12 hours at 25 mg/kg and 0.7 times the human exposure at 50 mg/kg.

Ceftaroline fosamil did not affect the postnatal development or reproductive performance of the offspring of rats given IV doses up to 450 mg/kg/day. Results from a toxicokinetic study conducted in pregnant rats with doses up to 300 mg/kg suggest that exposure was ≥ 4 times the exposure in humans given 600 mg every 12 hours. 8.

2 Lactation Risk Summary No data is available regarding the presence of ceftaroline in human milk, the effects of ceftaroline on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Teflaro and any potential adverse effects on the breastfed child from Teflaro or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Teflaro in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age). The safety and effectiveness of Teflaro in the treatment of CABP have been established in the age groups 2 months to less than 18 years old. Use of Teflaro in these age groups is supported by evidence from adequate and well-controlled studies of Teflaro in adults with additional pharmacokinetic and safety data in pediatric patients 2 months of age and older with ABSSSI or CABP [see Clinical Studies ( 14.1 and 14.2 )] .

Use of Teflaro in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. In these infants, concentrations of Teflaro in the cerebrospinal fluid were not evaluated [see Adverse Reactions ( 6.1 ) , Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.2 ) ] . Results from the clinical studies in pediatric patients show that Teflaro demonstrat… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no adequate studies with Teflaro in pregnant women that informed any drug associated risks. The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population.

In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed to Teflaro at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation. In rabbits exposed to Teflaro during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity. Data Animal Data Developmental toxicity studies performed with ceftaroline fosamil in rats at IV doses up to 300 mg/kg demonstrated no maternal toxicity and no effects on the fetus.

A separate toxicokinetic study showed that ceftaroline exposure in rats (based on AUC) at this dose level was approximately 4 times the exposure in humans given 600 mg every 12 hours. There were no drug-induced malformations in the offspring of rabbits given IV doses of 25, 50, and 100 mg/kg, despite maternal toxicity. Signs of maternal toxicity appeared secondary to the sensitivity of the rabbit gastrointestinal system to broad-spectrum antibacterials and included changes in fecal output in all groups and dose-related reductions in body weight gain and food consumption at > 50 mg/kg; these were associated with an increase in spontaneous abortion at 50 and 100 mg/kg.

The highest dose was also associated with maternal moribundity and mortality. An increased incidence of a common rabbit skeletal variation, angulated hyoid alae, was also observed at the maternally toxic doses of 50 and 100 mg/kg. A separate toxicokinetic study showed that ceftaroline exposure in rabbits (based on AUC) was approximately 0.4 times the exposure in humans given 600 mg every 12 hours at 25 mg/kg and 0.7 times the human exposure at 50 mg/kg.

Ceftaroline fosamil did not affect the postnatal development or reproductive performance of the offspring of rats given IV doses up to 450 mg/kg/day. Results from a toxicokinetic study conducted in pregnant rats with doses up to 300 mg/kg suggest that exposure was ≥ 4 times the exposure in humans given 600 mg every 12 hours.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of Teflaro in the treatment of ABSSSI have been established in pediatric patients (at least 34 weeks gestational age and 12 days postnatal age). The safety and effectiveness of Teflaro in the treatment of CABP have been established in the age groups 2 months to less than 18 years old. Use of Teflaro in these age groups is supported by evidence from adequate and well-controlled studies of Teflaro in adults with additional pharmacokinetic and safety data in pediatric patients 2 months of age and older with ABSSSI or CABP [see Clinical Studies ( 14.1 and 14.2 )] .

Use of Teflaro in pediatric patients less than 2 months of age was supported by pharmacokinetic and safety data in 11 infants at least 34 weeks gestational age and 12 days postnatal age. In these infants, concentrations of Teflaro in the cerebrospinal fluid were not evaluated [see Adverse Reactions ( 6.1 ) , Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.2 ) ] . Results from the clinical studies in pediatric patients show that Teflaro demonstrated a safety profile that was comparable with treatment of ABSSSI and CABP in adults at the clinical dosages studied.

Safety and effectiveness of Teflaro in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age for the treatment of ABSSSI have not been established. Safety and effectiveness of Teflaro in pediatric patients below the age of 2 months for the treatment of CABP have not been established as no data are available.

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use Of the 1300 adult patients treated with Teflaro in the Phase 3 ABSSSI and CABP trials, 397 (30.5%) were ≥ 65 years of age. The clinical cure rates in the Teflaro group (Clinically Evaluable [CE] Population) were similar in patients ≥ 65 years of age compared with patients < 65 years of age in both the ABSSSI and CABP trials. The adverse reaction profiles in patients ≥ 65 years of age and in patients < 65 years of age were similar.

The percentage of patients in the Teflaro group who had at least one adverse reaction was 52.4% in patients ≥ 65 years of age and 42.8% in patients < 65 years of age for the two indications combined. Ceftaroline is excreted primarily by the kidney, and the risk of adverse reactions 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 in this age group and it may be useful to monitor renal function.

Elderly subjects had greater ceftaroline exposure relative to non-elderly subjects when administered the same single dose of Teflaro. However, higher exposure in elderly subjects was mainly attributed to age-related changes in renal function. Dosage adjustment for elderly patients should be based on renal function [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 113 words ▾

10. OVERDOSAGE Teflaro overdosage has occurred in patients with renal impairment. Reactions have included neurological sequelae, including encephalopathy [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 )] .

In the event of overdose, Teflaro should be discontinued and general supportive treatment given. Ceftaroline can be removed by hemodialysis. In subjects with ESRD administered 400 mg of Teflaro, the mean total recovery of ceftaroline in the dialysate following a 4-hour hemodialysis session started 4 hours after dosing was 76.5 mg (21.6% of the dose).

However, no information is available on the use of hemodialysis to treat overdosage [see Clinical Pharmacology ( 12.3 )] .

🧬 Clinical Pharmacology ~3 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ceftaroline is a cephalosporin antibacterial drug [ see Microbiology ( 12.4 )] .

12.2Pharmacodynamics As with other beta-lactam antimicrobial agents, the time that unbound plasma concentration of ceftaroline exceeds the minimum inhibitory concentration (MIC) of the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with S. aureus and S. pneumoniae . Exposure-response analysis of Phase 2/3 ABSSSI trials supports the recommended dosage regimen of Teflaro 600 mg every 12 hours by IV infusion over 1 hour. For Phase 3 CABP trials, an exposure-response relationship could not be identified due to the limited range of ceftaroline exposures in the majority of patients.

Cardiac Electrophysiology In a randomized, positive- and placebo-controlled crossover thorough QTc study, 54 healthy subjects were each administered a single dose of Teflaro 1500 mg, placebo, and a positive control by IV infusion over 1 hour. At the 1500 mg dose of Teflaro, no significant effect on QTc interval was detected at peak plasma concentration or at any other time.

12.3Pharmacokinetics The mean pharmacokinetic parameters of ceftaroline in healthy adults (n=6) with normal renal function after single and multiple 1-hour IV infusions of 600 mg ceftaroline fosamil administered every 12 hours are summarized in Table 8. Pharmacokinetic parameters were similar for single and multiple dose administration. Table 8: Mean (Standard Deviation) Pharmacokinetic Parameters of Ceftaroline IV in Healthy Adults Parameter Single 600 mg Dose Administered as a 1-Hour Infusion (n=6) Multiple 600 mg Doses Administered Every 12 Hours as 1-Hour Infusions for 14 Days (n=6) C max (mcg/mL) 19.0 (0.71) 21.3 (4.10) T max (h) a 1.00 (0.92-1.25) 0.92 (0.92-1.08) AUC (mcg • h/mL) b 56.8 (9.31) 56.3 (8.90) T 1/2 (h) 1.60 (0.38) 2.66 (0.40) CL (L/h) 9.58 (1.85) 9.60 (1.40) a Reported as median (range) b AUC 0-∞ , for single-dose administration; AUC 0-tau , for multiple-dose administration; C max , maximum observed concentration; T max , time of C max ; AUC 0-∞ , area under concentration-time curve from time 0 to infinity; AUC 0-tau , area under concentration-time curve over dosing interval (0-12 hours); T 1/2 , terminal elimination half-life; CL, plasma clearance The C max and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1000 mg.

No appreciable accumulation of ceftaroline is observed following multiple IV infusions of 600 mg administered every 12 hours for up to 14 days in healthy adults with normal renal function. The systemic exposure (AUC), T 1/2 , and clearance of ceftaroline were similar following administration of 600 mg ceftaroline fosamil in a volume of 50 mL to healthy subjects every 8 hours for 5 days as a 5-minute or 60-minute infusion, and the T max of ceftaroline occurred about 5 minutes after the end of the ceftaroline fosamil infusion for both infusion durations.

The mean (SD) C max of ceftaroline was 32.5 (4.82) mcg/mL for the 5-minute infusion duration (n=11) and 17.4 (3.87) mcg/mL for the 60-minute infusion duration (n=12). Distribution The average binding of ceftaroline to human plasma proteins is approximately 20% and decreases slightly with increasing concentrations over 1-50 mcg/mL (14.5-28.0%). The median (range) steady-state volume of distribution of ceftaroline in healthy adult males (n=6) following a single 600 mg IV dose of radiolabeled ceftaroline fosamil was

20.3L (18.3-21.6 L), similar to extracellular fluid volume. Elimination Metabolism Ceftaroline fosamil is the water-soluble prodrug of the bioactive ceftaroline. Ceftaroline fosamil is converted into bioactive ceftaroline in plasma by a phosphatase enzyme and concentrations of the prodrug are measurable in plasma primarily during IV infusion.

Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ri… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action Ceftaroline is a cephalosporin antibacterial drug [ see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 73 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Teflaro (ceftaroline fosamil) for injection, a pale yellowish-white to light yellow sterile powder, is supplied in single-dose, clear glass vials containing: 600 mg - individual vial (NDC 0456-0600-01) and carton containing 10 vials (NDC 0456-0600-10) 400 mg - individual vial (NDC 0456-0400-01) and carton containing 10 vials (NDC 0456-0400-10) Teflaro vials (unreconstituted) should be stored at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

📋 Description 209 words ▾

11. DESCRIPTION TEFLARO (ceftaroline fosamil) for injection, is a sterile, semi-synthetic, prodrug of the cephalosporin antibacterial class of beta-lactams (β-lactams) for intravenous use. Chemically, the prodrug, ceftaroline fosamil monoacetate monohydrate is (6 R ,7 R )-7-{(2 Z )-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate.

Its molecular weight is 762.75. The empirical formula is C 22 H 21 N 8 O 8 PS 4 .C 2 H 4 O 2 .H 2 O. Figure 1: Chemical structure of ceftaroline fosamil Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil (equivalent to 668 mg and 446 mg, respectively, of ceftaroline fosamil monoacetate monohydrate).

The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. Each vial of 400 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 263.3 mg/vial as the solubilizer and alkalizing agent. Each vial of 600 mg of anhydrous ceftaroline fosamil includes inactive ingredient L-arginine 395.0 mg/vial as the solubilizer and alkalizing agent.

All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration ( 2.3 )] . The pH of the constituted solution is pH 4.8 to 6.5.

Figure 1: Chemical structure of ceftaroline fosamil

💬 Information for Patients ~1 min read ▾

17. PATIENT COUNSELING INFORMATION Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. They should inform their healthcare provider about any previous hypersensitivity reactions to Teflaro, other beta-lactams (including cephalosporins) or other allergens.

Advise patients that neurological adverse reactions could occur with Teflaro use. Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including somnolence, lethargy, confusion, and slow thinking), and seizures for immediate treatment, dosage adjustment, or discontinuation of Teflaro. Patients should be counseled that antibacterial drugs including Teflaro should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When Teflaro 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 Teflaro or other antibacterial drugs in the future.

Advise patients that diarrhea is a common problem caused by antibacterial drugs, including Teflaro and usually resolves when the drug is discontinued. 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, patients should contact their healthcare provider.

Distributed by: AbbVie Inc. North Chicago, IL 60064 TEFLARO and its design are trademarks of Allergan Sales, LLC, an AbbVie company. Baxter® is a registered trademark and Mini-Bag Plus™ is a trademark of Baxter International Inc. © 2024 AbbVie.

All rights reserved. v6.2USPI0600

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The mean pharmacokinetic parameters of ceftaroline in healthy adults (n=6) with normal renal function after single and multiple 1-hour IV infusions of 600 mg ceftaroline fosamil administered every 12 hours are summarized in Table 8. Pharmacokinetic parameters were similar for single and multiple dose administration. Table 8: Mean (Standard Deviation) Pharmacokinetic Parameters of Ceftaroline IV in Healthy Adults Parameter Single 600 mg Dose Administered as a 1-Hour Infusion (n=6) Multiple 600 mg Doses Administered Every 12 Hours as 1-Hour Infusions for 14 Days (n=6) C max (mcg/mL) 19.0 (0.71) 21.3 (4.10) T max (h) a 1.00 (0.92-1.25) 0.92 (0.92-1.08) AUC (mcg • h/mL) b 56.8 (9.31) 56.3 (8.90) T 1/2 (h) 1.60 (0.38) 2.66 (0.40) CL (L/h) 9.58 (1.85) 9.60 (1.40) a Reported as median (range) b AUC 0-∞ , for single-dose administration; AUC 0-tau , for multiple-dose administration; C max , maximum observed concentration; T max , time of C max ; AUC 0-∞ , area under concentration-time curve from time 0 to infinity; AUC 0-tau , area under concentration-time curve over dosing interval (0-12 hours); T 1/2 , terminal elimination half-life; CL, plasma clearance The C max and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1000 mg.

No appreciable accumulation of ceftaroline is observed following multiple IV infusions of 600 mg administered every 12 hours for up to 14 days in healthy adults with normal renal function. The systemic exposure (AUC), T 1/2 , and clearance of ceftaroline were similar following administration of 600 mg ceftaroline fosamil in a volume of 50 mL to healthy subjects every 8 hours for 5 days as a 5-minute or 60-minute infusion, and the T max of ceftaroline occurred about 5 minutes after the end of the ceftaroline fosamil infusion for both infusion durations.

The mean (SD) C max of ceftaroline was 32.5 (4.82) mcg/mL for the 5-minute infusion duration (n=11) and 17.4 (3.87) mcg/mL for the 60-minute infusion duration (n=12). Distribution The average binding of ceftaroline to human plasma proteins is approximately 20% and decreases slightly with increasing concentrations over 1-50 mcg/mL (14.5-28.0%). The median (range) steady-state volume of distribution of ceftaroline in healthy adult males (n=6) following a single 600 mg IV dose of radiolabeled ceftaroline fosamil was

20.3L (18.3-21.6 L), similar to extracellular fluid volume. Elimination Metabolism Ceftaroline fosamil is the water-soluble prodrug of the bioactive ceftaroline. Ceftaroline fosamil is converted into bioactive ceftaroline in plasma by a phosphatase enzyme and concentrations of the prodrug are measurable in plasma primarily during IV infusion.

Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite ceftaroline M-1. The mean (SD) plasma ceftaroline M-1 to ceftaroline AUC 0-∞ ratio following a single 600 mg IV infusion of ceftaroline fosamil in healthy adults (n=6) with normal renal function is 28% (3.1%). When incubated with pooled human liver microsomes, ceftaroline was metabolically stable (< 12% metabolic turnover), indicating that ceftaroline is not a substrate for hepatic CYP450 enzymes.

Excretion Ceftaroline and its metabolites are primarily eliminated by the kidneys. Following administration of a single 600 mg IV dose of radiolabeled ceftaroline fosamil to healthy male adults (n=6), approximately 88% of radioactivity was recovered in urine and 6% in feces within 48 hours. Of the radioactivity recovered in urine approximately 64% was excreted as ceftaroline and approximately 2% as ceftaroline M-1.

The mean (SD) renal clearance of ceftaroline was 5.56 (0.20) L/h, suggesting that ceftaroline is predominantly eliminated by glomerular filtration. Speci fic Populations Patients with Renal Impairment Following administration of a single 600 mg IV dose of Teflaro, the geometric mean AUC 0-∞ of ceftaroline in subjects with m… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 158 words ▾

12.2Pharmacodynamics As with other beta-lactam antimicrobial agents, the time that unbound plasma concentration of ceftaroline exceeds the minimum inhibitory concentration (MIC) of the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with S. aureus and S. pneumoniae . Exposure-response analysis of Phase 2/3 ABSSSI trials supports the recommended dosage regimen of Teflaro 600 mg every 12 hours by IV infusion over 1 hour. For Phase 3 CABP trials, an exposure-response relationship could not be identified due to the limited range of ceftaroline exposures in the majority of patients.

Cardiac Electrophysiology In a randomized, positive- and placebo-controlled crossover thorough QTc study, 54 healthy subjects were each administered a single dose of Teflaro 1500 mg, placebo, and a positive control by IV infusion over 1 hour. At the 1500 mg dose of Teflaro, no significant effect on QTc interval was detected at peak plasma concentration or at any other time.

🔬 Clinical Studies ~3 min read ▾

14. CLINICAL STUDIES

14.1Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Adult Patients A total of 1396 adults with clinically documented complicated skin and skin structure infection were enrolled in two identical randomized, multi-center, multinational, double-blind, non-inferiority trials (Trials 1 and 2) comparing Teflaro (600 mg administered IV over 1 hour every 12 hours) to vancomycin plus aztreonam (1 g vancomycin administered IV over 1 hour followed by 1 g aztreonam administered IV over 1 hour every 12 hours). Treatment duration was 5 to 14 days.

A switch to oral therapy was not allowed. The Modified Intent-to-Treat (MITT) population included all patients who received any amount of study drug according to their randomized treatment group. The Clinically Evaluable (CE) population included patients in the MITT population who demonstrated sufficient adherence to the protocol.

To evaluate the treatment effect of ceftaroline, an analysis was conducted in 797 patients with ABSSSI (such as deep/extensive cellulitis or a wound infection [surgical or traumatic]) for whom the treatment effect of antibacterials may be supported by historical evidence. This analysis evaluated responder rates based on achieving both cessation of lesion spread and absence of fever on Study Day 3 in the following subgroup of patients: Patients with lesion size ≥ 75 cm 2 and having one of the following infection types: Major abscess with ≥ 5 cm of surrounding erythema Wound infection Deep/extensive cellulitis The results of this analysis are shown in Table 9.

Table 9: Clinical Responders at Study Day 3 from Two Adult Phase 3 ABSSSI Trials Teflaro n/N (%) Vancomycin/ Aztreonam n/N (%) Treatment Difference (2-sided 95% CI) ABSSSI Trial 1 148/200 (74.0) 135/209 (64.6) 9.4 (0.4, 18.2) ABSSSI Trial 2 148/200 (74.0) 128/188 (68.1) 5.9 (-3.1, 14.9) The protocol-specified analyses included clinical cure rates at the Test of Cure (TOC) (visit 8 to 15 days after the end of therapy) in the co-primary CE and MITT populations (Table 10) and clinical cure rates at TOC by pathogen in the Microbiologically Evaluable (ME) population (Table 11).

However, there are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point. Therefore, comparisons of Teflaro to vancomycin plus aztreonam based on clinical response rates at TOC cannot be utilized to establish non-inferiority. Table 10: Clinical Cure Rates at TOC from Two Adult Phase 3 ABSSSI Trials Teflaro n/N (%) Vancomycin/ Aztreonam n/N (%) Treatment Difference (2-sided 95% CI) Trial 1 CE 288/316 (91.1) 280/300 (93.3) -2.2 (-6.6, 2.1) MITT 304/351 (86.6) 297/347 (85.6) 1.0 (-4.2, 6.2) Trial 2 CE 271/294 (92.2) 269/292 (92.1) 0.1 (-4.4., 4.5) MITT 291/342 (85.1) 289/338 (85.5) -0.4 (-5.8, 5.0) Table 11: Clinical Cure Rates at TOC by Pathogen from Two Adult Integrated Phase 3 ABSSSI Trials Teflaro n/N (%) Vancomycin/Aztreonam n/N (%) Gram-positive: MSSA (methicillin-susceptible) MRSA (methicillin-resistant) 212/228 (93.0%) 142/152 (93.4%) 225/238 (94.5%) 115/122 (94.3%) Streptococcus pyogenes 56/56 (100%) 56/58 (96.6%) Streptococcus agalactiae 21/22 (95.5%) 18/18 (100%) Gram-negative: Escherichia coli 20/21 (95.2%) 19/21 (90.5%) Klebsiella pneumoniae 17/18 (94.4%) 13/14 (92.9%) Klebsiella oxytoca 10/12 (83.3%) 6/6 (100%) Of the 693 patients in the MITT population in the Teflaro arm in the two ABSSSI trials, 20 patients had baseline S. aureus bacteremia (nine MRSA and eleven MSSA).

Thirteen of these twenty patients (65%) were clinical responders for ABSSSI at Study Day 3 and 18/20 (90%) were considered clinical success for ABSSSI at TOC. Pediatric Patients The ABSSSI pediatric trial was a randomized, parallel-group, active controlled trial in pediatric patients 2 months to < 18 years of age. A total of 163 children from 2 months to < 18 years of age with clinically documented ABSSSI were enrolled in a randomized, multi-center, multin… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 148 words ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted with ceftaroline. Ceftaroline fosamil did not show evidence of mutagenic activity in in vitro tests that included a bacterial reverse mutation assay and the mouse lymphoma assay. Ceftaroline was not mutagenic in an in vitro mammalian cell assay.

In vivo , ceftaroline fosamil did not induce unscheduled DNA synthesis in rat hepatocytes and did not induce the formation of micronucleated erythrocytes in mouse or rat bone marrow. Both ceftaroline fosamil and ceftaroline were clastogenic in the absence of metabolic activation in an in vitro chromosomal aberration assays, but not in the presence of metabolic activation. IV injection of ceftaroline fosamil had no adverse effects on fertility of male and female rats given up to 450 mg/kg.

This is approximately 4-fold higher than the maximum recommended human dose based on body surface area.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 145 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted with ceftaroline. Ceftaroline fosamil did not show evidence of mutagenic activity in in vitro tests that included a bacterial reverse mutation assay and the mouse lymphoma assay. Ceftaroline was not mutagenic in an in vitro mammalian cell assay.

In vivo , ceftaroline fosamil did not induce unscheduled DNA synthesis in rat hepatocytes and did not induce the formation of micronucleated erythrocytes in mouse or rat bone marrow. Both ceftaroline fosamil and ceftaroline were clastogenic in the absence of metabolic activation in an in vitro chromosomal aberration assays, but not in the presence of metabolic activation. IV injection of ceftaroline fosamil had no adverse effects on fertility of male and female rats given up to 450 mg/kg.

This is approximately 4-fold higher than the maximum recommended human dose based on body surface area.

📄 Package Label / Principal Display Panel 126 words ▾

PRINCIPAL DISPLAY PANEL NDC 0456-0400-10 Rx only Teflaro ® ( ceftaroline fosamil ) for injection 10 Single- Dose Vials 400 mg/vial FOR INTRAVENOUS INFUSION ONLY CONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR INTRAVENOUS INFUSION abbvie NDC 0456-0400-10 Rx only Teflaro® (ceftaroline fosamil) for injection 10 Single-Dose Vials 400 mg/vial FOR INTRAVENOUS INFUSION ONLY CONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR INTRAVENOUS INFUSION abbvie

PRINCIPAL DISPLAY PANEL NDC 0456-06 00-10 Rx only Teflaro ® (ceftaroline fosamil) for i njection 10 Single- Dose Vials 600 mg/vial FOR INTRAVENOUS INFUSION ONLY CONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR INTRAVENOUS INFUSION abbvie NDC 0456-0600-10 Rx only Teflaro® (ceftaroline fosamil) for injection 10 Single-Dose Vials 600 mg/vial FOR INTRAVENOUS INFUSION ONLY CONSTITUTED SOLUTION MUST BE FURTHER DILUTED FOR INTRAVENOUS INFUSION abbvie

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
143
Units reimbursed last 4 qtrs
594
Gross reimbursed last 4 qtrs
$160.1K
Avg / prescription
$1,119.38
Avg / unit
$269.48
Latest quarter Q1 2026
0Rx
Fee-for-service vs managed care ⓘ
89% MCO
Fee-for-service · 16 Rx Managed care · 127 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 93 units · 1.0 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 75 units · 1.7 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 61 units · 1.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 107 units · 1.4 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 112 units · 2.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 146 units · 0.6 per 100k residents FL
Units reimbursed · per 100k residents
0.62.1
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 South Carolina 2.1 /100k
2 Kentucky 1.7 /100k
3 Arizona 1.4 /100k
4 New Jersey 1.0 /100k
5 Maryland 1.0 /100k
6 Florida 0.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Teflaro — 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 Teflaro. 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.
Period
Total Part D spend
$2.74M
Claims incl. refills
800
Beneficiaries
229
Spend / beneficiary
$11,959.82
Spend / claim
$3,423.50
Trend by period
💵 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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) ✓ Available
“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 Allergan, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Allergan, 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 J0712 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.
← 00441-3642-02 · Sigma-Aldrich 00456-0457-01 · Allergan, →
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.