What is it prescribed for?

ZEVTERA, approved on April 3, 2024, is indicated for the treatment of:  Adult patients with Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis,  Adult patients with acute bacterial skin and skin structure infections, and  Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia.

What is the name of the drug and what does it do?

Zevtera (pronounced ZEV-ter-uh), (generic name: ceftobiprole medocaril sodium), is an antibiotic used for the treatment of serious bacterial infections in adults and pediatric patients. It is indicated for treating Staphylococcus aureus bloodstream infections (bacteremia) including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP).

How does it work?

Zevtera is a cephalosporin antibacterial. Cephalosporins are a class of antibiotics that work by disrupting the synthesis of the bacterial cell wall, leading to the death of the bacteria. Zevtera specifically targets and inhibits the activity of penicillin-binding proteins (PBPs), which are essential for cell wall formation in bacteria. By inhibiting these proteins, Zevtera effectively kills the bacteria causing the infection.

What did the research discover?

Clinical trials have demonstrated that Zevtera is effective in treating a variety of serious bacterial infections. In studies involving patients with Staphylococcus aureus bloodstream infections, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia, Zevtera showed significant efficacy in eliminating the bacterial infections and reducing symptoms. The trials included adult patients and pediatric patients aged 3 months to less than 18 years.

What are some of the side effects?

  • Anemia
  • Nausea
  • Hypokalemia
  • Vomiting
  • Hepatic enzyme and bilirubin increased
  • Diarrhea
  • Blood creatinine increased
  • Hypertension
  • Leukopenia
  • Pyrexia

What are the dosage recommendations and how is it prescribed?

Zevtera is administered as an intravenous infusion. The recommended dosage and duration of treatment vary based on the type of infection and patient population:

  • Staphylococcus aureus bloodstream infection (SAB): 667 mg every 6 hours on Days 1 to 8, then every 8 hours from Day 9, for up to 42 days.
  • Acute bacterial skin and skin structure infections (ABSSSI): 667 mg every 8 hours for 5 to 14 days.
  • Community-acquired bacterial pneumonia (CABP): 667 mg every 8 hours for 5 to 14 days.

For pediatric patients aged 3 months to less than 18 years, the dosage is based on body weight, with specific guidelines for different age groups.

Source:

Basilea Pharmaceutica International Ltd. Zevtera (ceftobiprole medocaril sodium) for injection, for intravenous use. Prescribing Information. 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218275s000lbl.pdf

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