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Company : Cerexa Approval Status : November 2010

Company : Cerexa Approval Status : November 2010. Teflaro™ / ceftaroline fosamil Pharmacology. Ceftaroline fosamil is a cephalosporin with in vitro bactericidal action against Gram-positive and Gram-negative bacteria

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Company : Cerexa Approval Status : November 2010

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  1. Company:CerexaApproval Status:November 2010

  2. Teflaro™ / ceftaroline fosamilPharmacology • 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.

  3. Teflaro™ / ceftaroline fosamilClinical Application • Indications: • Treatment of acute bacterial skin and skin structure infections (ABSSI) caused by susceptible isolates of MRSA, S. aureus, S. pyogenes, S. agalactiae, E. coli, K. pneumoniae, and K. oxytoca • either a major abscess with greater-than or equal to 5 cm of surrounding erythema, wound infection, or deep/extensive cellulitis requiring • Treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of S. pneumoniae, S. aureus, H. influenzae, K. pneumoniae, K. oxytoca, and E. coli • respiratory symptom (cough, dyspnea, pleuritic chest pain, or sputum(

  4. Teflaro™ / ceftaroline fosamilDosage • 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.

  5. Teflaro™ / ceftaroline fosamilDosage

  6. Teflaro™ / ceftaroline fosamilPrescription Information • Supplied/Storage and Handling: • Single-use, clear glass vials • 400 mg or 600 mg • Vials should be refrigerated at 2 to 8°C

  7. Teflaro™ / ceftaroline fosamilPharmacokinetics

  8. Clinical ResultsAcute 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

  9. Clinical ResultsCommunity-Acquired Bacterial Pneumonia (CABP) • 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

  10. Teflaro™ / ceftaroline fosamilTrial 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

  11. Contraindications • Known serious hypersensitivity to Teflaro or other members of the cephalosporin class. • Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.

  12. Side Effects • DiarrheaClostridium difficile-associated diarrhea (CDAD) has been reported for nearly all antibacterial agents including Teflaro • Nausea • Rash • Vomiting • Constipation • Hypokalemia

  13. Teflaro™ / ceftaroline fosamilMonitoring 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

  14. Teflaro™ / ceftaroline fosamilDrug 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.

  15. THANKS 4 YOUR ATTENTION Doaa Hussien Al-Hamed

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