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FDA Approves Label Updates for Teflaro Medication

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Patrick Murray2 years ago

The FDA has approved a labeling update for Teflaro, a medication manufactured by Allergan that is also referred to as Ceftaroline Fosamil.

About the New Teflaro Product Labels

According to Medscape, Teflaro is used to treat patients diagnosed with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and/or Community-Acquired Bacterial Pneumonia (CABP).

The FDA has ordered that Teflaro carry updated product labels addressing concern with Teflaro’s efficacy in treating patients diagnosed with ABSSI with baseline Staphylococcus aureus (Staph) bacteremia. The new label will suggest shorter IV infusion time.

David Nicholson, Allergan’s executive vice president, said in a statement:

“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,

“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.”

The approval of the labels follows two studies comparing patients with ABSSSI treated with Teflaro monotherapy or vancomycin plus aztreonam, two antibiotic medications.

Statistics from the Teflaro Study

  • From the 693 patients in the modified intent-to-treat population in the Teflaro group, 20 patients had baseline Staph.
  • Nine of these 20 cases were diagnosed as MRSA, a much more severe case of Staph. The other eleven were diagnosed MSSA, the more regular case of Staph.
  • On the third day of use, thirteen of the 20 (65%) showed a clinical response to the treatment.
  • After a test of cure, 18 of the 20 (90%) were considered successful.
About the New Dosing Time
  • The new label allows for a range of infusion times from five minutes to one hour.
  • Previously the medicine was only approved for a one-hour infusion time.
  • New recommended dose is 600 mg for five to sixty minutes every twelve hours for five days to two weeks for ABSSSI and five to seven days for CABP.
  • Patients with renal impairment have slightly different dosing details and should be accommodated by their physicians.


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