pharmacopeia
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/api/v1/drug/ceftaroline-fosamil

Mechanism of action

Sourced from openFDA

Ceftaroline is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )] .

Enzyme

Indications

Sourced from openFDA
  • 1. INDICATIONS AND USAGE Ceftaroline fosamil for injection 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 ceftaroline fosamil for injection and other antibacterial drugs, ceftaroline fosamil for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.ICD-10: J18.9

Contraindications

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  • 4. CONTRAINDICATIONS Ceftaroline fosamil for injection is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class.contraindicated

Dosage & administration

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2. DOSAGE AND ADMINISTRATION Dosage of Ceftaroline Fosamil for Injection 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 every12 hours 5 to 60 minutes 5 to 7 days ≥2 years to < 18 years (> 33 kg) 400 mg every 8 hours OR 600 mg every12 hours 5 to 60 minutes 5 to 14 days ≥2 years to < 18 years (≤ 33kg) 12 mg/kg every8 hours 5 to 60 minutes 5 to 14 days 2 months to < 2 years 8 mg/kg every8 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 ) 2.1 Recommended Dosage in Adult Patients The recommended dosage of ceftaroline fosamil for injection is 600 mg administered every 12 hours by intravenous (IV) infusion over …

Warnings & precautions

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5. WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including ceftaroline. If a hypersensitivity reaction occurs, discontinue ceftaroline fosamil for injection. ( 5.1 ) Clostridiodes difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ceftaroline fosamil for injection. Evaluate if diarrhea occurs. ( 5.2 ) Neurological adverse reactions have been reported in patients treated with cephalosporins, including ceftaroline. If neurological adverse reactions occur, consider discontinuing ceftaroline fosamil for injection or making appropriate dosage adjustments in patients with renal impairment. ( 2.3 , 5.3 ) Direct Coombs’ test seroconversion has been reported with ceftaroline. If anemia develops during or after therapy, a diagnostic workup for drug- induced hemolytic anemia should be performed and consideration given to discontinuation of ceftaroline fosamil for injection. ( 5.4 ) 5.1 Hypersensitivity 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 ceftaroline fosamil for injection is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made.

Adverse reactions

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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 Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 Ceftaroline fosamil for injection was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1,300 adult patients treated with ceftaroline fosamil for injection (600 mg administered by IV over 1 hour every 12h) and 1,297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days.

Use in specific populations

Sourced from openFDA

8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate studies with ceftaroline fosamil in pregnant women that informed any drug associated risks. Th e background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2 to 4% and of miscarriage is 15 to 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 ceftaroline fosamil at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation. In rabbits exposed to ceftaroline fosamil 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.

Pharmacokinetics

Sourced from openFDA
Metabolism
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.

Overdosage

Sourced from openFDA

10. OVERDOSAGE Ceftaroline fosamil for injection 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, ceftaroline fosamil for injection should be discontinued and general supportive treatment given. Ceftaroline can be removed by hemodialysis. In subjects with ESRD administered 400 mg of ceftaroline fosamil for injection, 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 )] .

Approval history

Sourced from openFDA
  • Oct 29, 2010NDANDA200327Abbvie
  • Sep 21, 2021ANDAANDA208075Apotex

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
759 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use13418%
  2. 2Neutropenia668.7%
  3. 3Drug Ineffective648.4%
  4. 4Death476.2%
  5. 5Rash455.9%
  6. 6Thrombocytopenia374.9%
  7. 7Acute Kidney Injury364.7%
  8. 8Pyrexia334.3%
  9. 9Agranulocytosis253.3%
  10. 10Leukopenia233.0%
  11. 11Treatment Failure233.0%
  12. 12Pruritus222.9%
  13. 13Anaemia212.8%
  14. 14Eosinophilia192.5%
  15. 15Nausea192.5%

Literature

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Recent PubMed references pinned to Ceftaroline Fosamil as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 57 ClinicalTrials.gov registrations naming Ceftaroline Fosamil as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ceftaroline Fosamil work?
Ceftaroline is a cephalosporin antibacterial drug [see Microbiology ( 12.4 )] .
What is Ceftaroline Fosamil used for?
According to FDA labeling, Ceftaroline Fosamil carries indications including: 1. INDICATIONS AND USAGE Ceftaroline fosamil for injection 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 ceftaroline fosamil for injection and other antibacterial drugs, ceftaroline fosamil for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ceftaroline Fosamil?
Ceftaroline Fosamil is classified as Other cephalosporins and penems, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair.
What are the brand names for Ceftaroline Fosamil?
Ceftaroline Fosamil is marketed under brand names including Teflaro.
What are the contraindications for Ceftaroline Fosamil?
Ceftaroline Fosamil labeling lists contraindications including: 4. CONTRAINDICATIONS Ceftaroline fosamil for injection is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class.. Always consult the full prescribing information and a clinician.
Note. Data for ceftaroline-fosamil is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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