company: cerexa approval status: november 2010cerexa
TRANSCRIPT
Company: CerexaApproval Status:
November 2010
Teflaro™ / ceftaroline fosamil
Pharmacology
Ceftaroline fosamil is a cephalosporin with in vitro bactericidal action against Gram-positive and Gram-negative bacteria
It exerts its bactericidal action through binding to essential penicillin-binding proteins
Ceftaroline inhibits the unique PBP produced by MRSA (PBP2a) for which beta-lactams have little binding affinity
against S. aureus due to its affinity for PBP2a against Streptococcus pneumoniae due to its
affinity for PBP2x.
Teflaro™ / ceftaroline fosamil
Clinical Application
Indications:Indications:– Treatment of acute bacterial skin and skin structure Treatment of acute bacterial skin and skin structure
infections (ABSSI) caused by susceptible isolates of infections (ABSSI) caused by susceptible isolates of
MRSAMRSA , , S. aureusS. aureus, , S. pyogenesS. pyogenes, , S. agalactiaeS. agalactiae, , E. coliE. coli, , K. K. pneumoniaepneumoniae, and , and K. oxytocaK. oxytoca
either a major abscess with greatereither a major abscess with greater--than or equal to 5 than or equal to 5 cm of surrounding erythema, wound infection, or cm of surrounding erythema, wound infection, or deepdeep//extensive cellulitis requiring extensive cellulitis requiring
– Treatment of community-acquired bacterial pneumonia Treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of (CABP) caused by susceptible isolates of S. S. pneumoniaepneumoniae, , S. aureusS. aureus, , H. influenzaeH. influenzae, , K. pneumoniaeK. pneumoniae, , K. oxytocaK. oxytoca, and , and E. coliE. coli
respiratory symptom respiratory symptom ((cough, dyspnea, pleuritic chest pain, or cough, dyspnea, pleuritic chest pain, or sputumsputum((
Teflaro™ / ceftaroline fosamil
Dosage
Teflaro is supplied as 600 mg or 400 mg of sterile powder for reconstitution into a solution designed for intravenous administration (IV) .
The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 1 hour 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.
Teflaro™ / ceftaroline fosamil
Dosage
RecomRecommendemended d DuratioDuration n
InfusiInfusion on TimeTime
FrequeFrequencnc
DosaDosagege
InfectionInfection
5-14 5-14 daysdays
1 h1 hEvery Every 1212
600 600 mgmg
ABSSSIABSSSI
5-7 5-7 daysdays
1 h1 hEvery Every 1212
600 600 mgmg
CABPCABP
Teflaro™ / ceftaroline fosamil
Prescription Information
Supplied/Storage and Handling:– Single-use, clear
glass vials– 400 mg or 600 mg– Vials should be
refrigerated at 2 to 8°C
Teflaro™ / ceftaroline fosamil
Pharmacokinetics
A100% (given IV)
D
volume of distribution of 0.37 L/kg, serum half-life of 2.6 h, and a relatively low affinity for human proteins (~20%).
MCeftaroline fosamil is converted to bioactive ceftaroline by a phosphatase enzyme. No significant hepatic metabolism by CYP450 enzymes.
ECeftaroline and its metabolites are primarily eliminated by the kidneys by glomerular filtration.
Clinical Results Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Objective: Compare ceftaroline monotherapy with vancomycin plus aztreonam combination therapy for the treatment of adults with complicated skin and skin structure infections (cSSSI)
Trial Design: Phase 3, international, multicenter, randomized, double-blind, comparative efficacy and safety studies
Intervention:–600 mg IV ceftaroline followed by normal
saline placebo or 1 g of vancomycin followed by 1 g of aztreonam over 5 to 14 days
Clinical ResultsCommunity-Acquired Bacterial Pneumonia (CABP)
1. Objective: trials were designed to compare Teflaro
(600 mg administered IV over 1 hour every 12 hours) with ceftriaxone (1 g ceftriaxone administered IV over 30 minutes every 24 hours
Teflaro™ / ceftaroline fosamil
Trial ConclusionsTrial Conclusions
Ceftaroline is noninferior to vancomycin plus aztreonam for the treatment of cSSSI
Ceftaroline an efficacious monotherapy for the treatment of cSSSI, including MRSA
Ceftaroline is generally safe and well-tolerated
ceftaroline to be noninferior to ceftriaxone for the treatment of CABP
Contraindications
Known serious hypersensitivity to Teflaro or other members of the cephalosporin class.
Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.
Side Effects
Diarrhea Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all antibacterial agents including Teflaro
Nausea Rash Vomiting Constipation Hypokalemia
Teflaro™ / ceftaroline fosamil
Monitoring Parameters
Efficacy Monitoring:– Resolution of infection, including but not
limited to WBC, temperature, chest x-ray, and repeat cultures
Toxicity Monitoring:– Hypersensitivity reactions and severe
watery or bloody diarrhea
Teflaro™ / ceftaroline fosamil
Drug Interactions
No clinical drug-drug interaction studies have been conducted
Unlikely to have CYP450 interactions : Therefore neither ceftaroline fosamil nor
ceftaroline are expected to inhibit or induce the clearance of drugs that are metabolized by these metabolic pathways in a clinically relevant manner.
THANKS 4 YOUR THANKS 4 YOUR ATTENTIONATTENTION
Doaa Hussien Al-Hamed