Zevtera FDA Approval History
Last updated by Judith Stewart, BPharm on April 9, 2024.
FDA Approved: Yes (First approved April 3, 2024)
Brand name: Zevtera
Generic name: ceftobiprole medocaril
Dosage form: for Injection
Company: Basilea Pharmaceutica Ltd.
Treatment for: Bacteremia, Skin and Structure Infection, Pneumonia
Zevtera (ceftobiprole medocaril) is a cephalosporin antibiotic for the treatment of bacteremia, acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia.
- Zevtera is indicated for the treatment of:
- adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis,
- adult patients with acute bacterial skin and skin structure infections (ABSSSI), and
- adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).
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. - Zevtera is an advanced generation cephalosporin antibiotic that works by inhibiting bacterial cell wall synthesis. It has rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.
- FDA approval of Zevtera was supported by results from the phase 3 studies ERADICATE (SAB) and TARGET (ABSSSI), and a phase 3 study in CABP.
- Zevtera is administered by intravenous infusion over a period of 2 hours.
- Warnings and precautions associated with Zevtera include increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) patients, hypersensitivity reactions, seizures and other adverse central nervous system reactions, and Clostridioides difficile-associated diarrhea.
- - Common adverse reactions in adults with SAB include anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, increased blood creatinine, hypertension, leukopenia, and pyrexia.
- Common adverse reactions in adults with ABSSSI include nausea, diarrhea, headache, injection site reaction, hepatic enzyme increased, rash, vomiting, and dysgeusia.
- Common adverse reactions in adults with CABP include nausea, increased hepatic enzymes, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness.
- Common adverse reactions in pediatric patients with CABP include vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis and pyrexia.
Development timeline for Zevtera
Further information
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