FDA approved Zevtera (ceftobiprole) for Staphylococcus aureus Bloodstream Infections, ABSSSI, and CABPFDA approved new antibiotic Zevtera for serious bacterial infections.

FDA From the archive Source published April 3, 2024 Summary added July 1, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Zevtera as a new cephalosporin option for MRSA bloodstream infections, including right-sided endocarditis, and for ABSSSI and CABP.

The FDA approved Zevtera (ceftobiprole medocaril sodium) on April 3, 2024, for the treatment of adult patients with Staphylococcus aureus bloodstream infections (SAB), including right-sided infective endocarditis, and acute bacterial skin and skin structure infections (ABSSSI). The drug is also approved for adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP). Zevtera is a cephalosporin antibacterial active against methicillin-susceptible and methicillin-resistant Staphylococcus aureus isolates. For SAB, the recommended dose is 667 mg every 6 hours on days 1 to 8, then every 8 hours from day 9, infused over 2 hours. Duration of therapy is up to 42 days for SAB and 5 to 14 days for ABSSSI and CABP. The approval offers a new treatment option for serious MRSA infections, particularly bloodstream infections and endocarditis, where treatment options are limited.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Zevtera (ceftobiprole) is a cephalosporin antibacterial. Its mechanism of action is not detailed in the provided label text.

Indication & Patient Population

Zevtera is indicated for: (1) adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates; (2) adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of Staphylococcus aureus (methicillin-susceptible and methicillin-resistant), Streptococcus pyogenes, and Klebsiella pneumoniae; (3) adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of Staphylococcus aureus (methicillin-susceptible), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae.

Dosing & Administration

For adult patients: SAB: 667 mg every 6 hours on Days 1 to 8, then every 8 hours from Day 9; ABSSSI and CABP: 667 mg every 8 hours. Administer each dose as an intravenous infusion over 2 hours at a concentration of 2.67 mg/mL. Duration: up to 42 days for SAB, 5 to 14 days for ABSSSI and CABP. For pediatric patients (3 months to <18 years) with CABP: 12 to <18 years: 13.3 mg/kg (up to 667 mg) every 8 hours; 3 months to <12 years: 20 mg/kg (up to 667 mg) every 8 hours. Infuse over 2 hours at 2.67 mg/mL for ages 12 to <18, and at 5.33 mg/mL for ages 3 months to <12. Duration: 7 to 14 days. Dosage adjustment is required in adult patients with CLcr <50 mL/min (including those on hemodialysis) and in those with CLcr >150 mL/min. For pediatric patients aged 2 to <18 years with eGFR <50 and ≥15 mL/min/1.73 m², dosage reduction is needed.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Zevtera provides a new cephalosporin option for the treatment of MRSA infections, particularly for SAB including right-sided infective endocarditis, ABSSSI, and CABP. It offers an alternative to vancomycin and daptomycin for these indications.

The FDA has approved a new antibiotic called Zevtera (ceftobiprole) to treat serious bacterial infections. It is used for adults with Staphylococcus aureus bloodstream infections, including right-sided infective endocarditis, and acute bacterial skin infections. It is also approved for adults and children (3 months to under 18 years) with community-acquired bacterial pneumonia. Zevtera is a cephalosporin that works against both methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MRSA).

For bloodstream infections, the recommended dose is 667 mg every 6 hours for the first 8 days, then every 8 hours starting day 9, given as a 2-hour infusion. Treatment can last up to 42 days for bloodstream infections and 5 to 14 days for skin infections and pneumonia.

This approval offers a new treatment option for serious MRSA infections, especially bloodstream infections and endocarditis, where options are limited. However, this does not mean Zevtera is right for everyone. Patients should talk to their doctor to see if this drug is appropriate for their specific condition.

What this means for you:

Zevtera is a new antibiotic for serious MRSA infections; talk to your doctor about treatment options.

Study Details

Study typeFda approval

PublishedApr 2024

View Original Abstract ↓

1 INDICATIONS AND USAGE ZEVTERA is a cephalosporin antibacterial indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis ( 1.1 ), Adult patients with acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 ), and Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP) ( 1.3 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1.4 ). 1.1 Staphylococcus aureus Bloodstream Infection (Bacteremia) ZEVTERA is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates . 1.2 Acute Bacterial Skin and Skin Structure Infections ZEVTERA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae. 1.3 Community-Acquired Bacterial Pneumonia ZEVTERA is indicated for the treatment of adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae , Haemophilus parainfluenzae , Escherichia coli , and Klebsiella pneumoniae. 1.4 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven, or strongly suspected, to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

FDA approved Zevtera (ceftobiprole) for Staphylococcus aureus Bloodstream Infections, ABSSSI, and CABPFDA approved new antibiotic Zevtera for serious bacterial infections.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

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FDA approved Zevtera (ceftobiprole) for Staphylococcus aureus Bloodstream Infections, ABSSSI, and CABPFDA approved new antibiotic Zevtera for serious bacterial infections.

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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