FDA OKs Label Update for Antibiotic Ceftaroline Fosamil

Megan Brooks

Disclosures

September 02, 2015

The US Food and Drug Administration (FDA) has approved a labeling update for ceftaroline fosamil (Teflaro, Allergan) used to treat adults with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), the company announced today.

The updated label includes new data on efficacy in patients with ABSSSI with baseline Staphylococcus aureus bacteremia and allows for a shorter intravenous (IV) infusion time.

"The new clinical data in the Teflaro label will allow for use in ABSSSI patients with baseline S. aureus bacteremia, the incidence of which has increased sharply in recent years, and provides physicians with the ability to treat patients with these serious infections," David Nicholson, Allergan executive vice president, said in a statement.

"In addition, with a shorter infusion time Teflaro provides increased flexibility in dosing that may allow physicians, nurses and other healthcare professionals to optimize the delivery of care in hospital and home settings," he noted.

Approval of the updated label was based on data from two studies comparing patients with ABSSSI treated with ceftaroline fosamil monotherapy or vancomycin plus aztreonam, the company said. Among 693 patients in the modified intent-to-treat population in the ceftaroline fosamil groups of the two studies, 20 patients had baseline S aureus bacteremia, including nine cases of methicillin-resistant Staphylococcus aureus (MRSA) and 11 cases of methicillin-susceptible S aureus (MSSA).

Thirteen (65%) of these 20 patients achieved clinical response to ceftaroline fosamil on the third day, and 18 (90%) of 20 patients were considered clinical success at test of cure. These data are now included in the clinical trial section of the Teflaro prescribing information, the company said.

Updated Dosing Time

The new label also now allows an infusion time of 5 to 60 minutes. Previously, ceftaroline fosamil was approved for IV infusion over 1 hour.

The recommended dosing is 600 mg IV for 5 to 60 minutes every 12 hours for 5 to 14 days for ABSSSI and 5 to 7 days for CABP, the company said.

For patients with renal impairment, the antibiotic should be given in a 5- to 60-minute infusion every 12 hours at the following dosages: 600 mg for patients with creatinine clearance (CrCl) higher than 50 mL/minute, 400 mg with CrCl higher than 30 to 50 mL/minute or less, 300 mg with CrCl between 15 and 30 mL/minute, and 200 mg in patients with end-stage renal disease (CrCl <15 mL/minute), including hemodialysis.

Ceftaroline fosamil is a bactericidal cephalosporin with activity against both Gram-positive and Gram-negative pathogens. It was first approved in the United States in October 2010 for the treatment of adults with CABP and ABSSSI as a result of designated susceptible pathogens.

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