Ceftaroline fosamil

1. INDICATIONS AND USAGE Teflaro is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age). Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Ceftaroline is a cephalosporin antibacterial drug.

2. DOSAGE AND ADMINISTRATION Dosage of Teflaro by Indication in Adult and Pediatric Patients. Indication Age Range Dosage Infusion Time Duration Acute Bacterial Skin and Skin Structure Infections (ABSSSI) 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to < 18 years (> 33 kg) 400 mg every 8 hours OR 600 mg every 12 hours 5 to 60 minutes 5 to 14 days ≥2 years to < 18 years (≤ 33kg) 12 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 2 months to < 2 years 8 mg/kg every 8 hours 5 to 60 minutes 5 to 14 days 0* to < 2 months 6 mg/kg every 8 hours 30 to 60 minutes 5 to 14 days *Gestational age 34 weeks and older and postnatal age 12 days and older Indication Age Range Dosage Infusion Time Duration Community Acquired Bacterial Pneumonia (CABP) 18 years and older 600 mg every 12 hours 5 to 60 minutes 5 to 7 days ≥2 years to < 18 years (> 33 kg) 400 mg every 8…

4. CONTRAINDICATIONS Teflaro is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis has been reported with ceftaroline. Known serious hypersensitivity to ceftaroline or other members of the cephalosporin class.

5. WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs, including Teflaro. If a hypersensitivity reaction occurs, discontinue Teflaro. Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Teflaro. Evaluate if diarrhea occurs. Neurological adverse reactions have been reported in patients treated with cephalosporins, including Teflaro. If neurological adverse reactions occur, consider discontinuing Teflaro or making appropriate dosage adjustments in patients with renal impairment. Direct Coombs’ test seroconversion has been reported with Teflaro. If anemia develops during or after therapy, a diagnostic workup for drug-induced hemolytic anemia should be performed and consideration given to discontinuation of Teflaro.

6. ADVERSE REACTIONS The following serious adverse reactions are described in greater detail in the Warnings and Precautions section Hypersensitivity Reactions Clostridioides difficile -Associated diarrhea Neurological Adverse Reactions Direct Coombs’ Test Seroconversion The most common adverse reactions occurring in >2% of adult patients and ≥3% of pediatric patients are diarrhea, nausea, and rash. Additional adverse reactions that occurred in ≥3% of pediatric patients include vomiting and pyrexia.

HOW SUPPLIED/STORAGE AND HANDLING Teflaro (ceftaroline fosamil) for injection, a pale yellowish-white to light yellow sterile powder, is supplied in single-dose, clear glass vials containing: 600 mg - individual vial (NDC 0456-0600-01) and carton containing 10 vials (NDC 0456-0600-10) 400 mg - individual vial (NDC 0456-0400-01) and carton containing 10 vials (NDC 0456-0400-10) Teflaro vials (unreconstituted) should be stored at 25ºC (77ºF), excursions permitted to 15-30ºC (59-86ºF).