General Information

Teflaro is specifically indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of applicable Gram-positive and Gram-negative microorganisms and for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of the applicable Gram-positive and Gram-negative microorganisms.

Mechanism of Action

Teflaro is a cephalosporin antibiotic with in vitro activity against Gram-positive and -negative bacteria. The bactericidal action of Ceftaroline is mediated through binding to essential penicillin-binding proteins (PBPs). Ceftaroline is bactericidal against S. aureus due to its affinity for PBP2a and against streptococcus pneumoniae due to its affinity for PBP2x.

Side Effects

Adverse events associated with the use of Teflaro may include, but are not limited to, the following:

Diarrhea

Nausea

Rash

Dosing/Administration

Teflaro is supplied as 600 mg or 400 mg of sterile powder for reconstitution into a solution designed for intravenous administration. The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over one 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.

Clinical Trial Results

FDA approval of Teflaro was based on the following trials:

Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Two identical randomized, multi-center, multinational, double-blind, noninferiority trials (trials One and Two) enrolled 1,396 adults with clinically documented complicated ABSSSI. The subjects received Teflaro (600 mg administered IV over one hour every 12 hours) or vancomycin plus aztreonam (1 g vancomycin administered IV over one hour followed by 1 g aztreonam administered IV over one hour every 12 hours). Treatment duration was five to 14 days. Trial One: at study day three in the Teflaro arm, 74 percent of the subjects were clinical responders, while 64.6 percent of subjects in the vancomycin plus aztreonam arm were clinical responders. Trial Two: at study day three in the Teflaro arm, 74 percent of the subjects were clinical responders, while 68.1 percent of subjects in the vancomycin plus aztreonam arm were clinical responders.

Community-Acquired Bacterial Pneumonia (CABP)

Two randomized, multi-center, multinational, double blind, noninferiority trials enrolled 1,231 adults. The trials were designed to compare Teflaro (600 mg administered IV over one hour every 12 hours) with ceftriaxone (1 g ceftriaxone administered IV over 30 minutes every 24 hours). In both treatment groups of Trial One, two doses of oral clarithromycin (500 mg every 12 hours) were administered as adjunctive therapy starting on study day one. No adjunctive macrolide therapy was used in CABP Trial Two. Treatment duration was five to seven days. The response rates at study day four (72-96 hours) were Trial One: Teflaro 69.6 percent responders and Ceftriaxone 58.3 percent responders, and Trial Two: Teflaro 69.0 percent responders and Ceftriaxone 61.4 percent responders.