Ceftobiprole

ZEVTERA is an antibacterial drug [see Microbiology (12.4) ]

• 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 ).ICD-10: J18.9

• ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class [see Warnings and Precautions (5.2) ]. ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class ( 4 ).contraindicated

The recommended dosage of ZEVTERA for adult patients with SAB, ABSSSI and CABP is described in the table below ( 2.1 ): Indication in Adults Dose Frequency SAB 667 mg Every 6 hours on Days 1 to 8 Every 8 hours from Day 9 ABSSSI 667 mg Every 8 hours CABP 667 mg Every 8 hours Duration of treatment in adult patients is up to 42 days for SAB and 5 days to 14 days for ABSSSI and CABP ( 2.1 ). Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL ( 2.1 , 2.6 ). The recommended dosage of ZEVTERA for pediatric patients (3 months to less than 18 years old) with CABP is described below ( 2.2 ). Pediatric Age Group for CABP Dose Frequency 12 years to less than 18 years old 13.3 mg/kg (up to 667 mg/dose) Every 8 Hours Greater than or equal to 3 months and less than 12 years old 20 mg/kg (up to 667 mg/dose) Every 8 Hours Duration of treatment in pediatric patients is 7 days to 14 days for CABP ( 2.1 ). Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL for pediatric patients aged 12 years to less than 18 years old and at a concentration of 5.33 mg/mL for pediatric patients aged 3 months to less than 12 years old ( 2.2 , 2.6 ). Reduce the dosage in adult patients with CL CR less than 50 mL/min, including patients with CL CR less than 15 mL/min on hemodialysis ( 2.3 and 8.6 ). Increase the dosage in adult patients with CL CR greater than 150 mL/min ( 2.3 ).

Increased Mortality with Unapproved use in Ventilator-Associated Bacterial Pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved ( 5.1 ). Hypersensitivity Reactions: Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment ( 5.2 ). Seizures and other adverse central nervous system (CNS) reactions have been associated with the use of ZEVTERA. If seizures or other CNS adverse reactions occur, evaluate patients to determine whether ZEVTERA should be discontinued ( 5.3 ). Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA. Evaluate if diarrhea occurs ( 5.4 ). 5.1 Increased Mortality with Unapproved Use in Ventilator-Associated Bacterial Pneumonia Patients In Trial 4, an increase in mortality was seen in the subgroup of patients with ventilator-associated bacterial pneumonia (VABP) who were treated with ZEVTERA (35/103 [34%] versus 24/102 [24%] in comparator-treated patients) [see Adverse Reactions (6.1) ] . The cause of this increased mortality has not been established. Generally, deaths were associated with complications of infection or underlying co-morbidities. The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved.

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Increased Mortality in Ventilator-Associated Bacterial Pneumonia Patients [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Contraindications (4) and Warning and Precautions (5.2) ] Seizures and Other Central Nervous System Reactions [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.4) ] SAB (adult patients): The most common adverse reactions occurring in ≥ 4% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, and pyrexia ( 6.1 ). ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increased, rash, vomiting, and dysgeusia ( 6.1 ). CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness ( 6.1 ). Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis and pyrexia ( 6.1 ).

8.1 Pregnancy Risk Summary There are no available data with use of ZEVTERA in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes . Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups, and cannot definitively establish the absence of risk. Intravenous administration of ceftobiprole medocaril to pregnant rats and monkeys during organogenesis showed no evidence of adverse fetal developmental outcomes at doses approximately 1.4 times and 0.9 times, respectively, the maximum recommended human dose (MRHD). Some evidence of maternal toxicity (slight reduction in body weight and food consumption) was noted in pregnant monkeys at 0.9 times the MRHD. Intravenous administration of ceftobiprole medocaril to rats 2-weeks prior to mating, during organogenesis, and through lactation resulted in no adverse fertility or fetal development effects in offspring at doses approximately 1.4 times the MRHD ( see Data ).

Metabolism

Ceftobiprole medocaril is the prodrug of the active moiety ceftobiprole. No clinically significant differences in the pharmacokinetics of ceftobiprole were observed with ZEVTERA following single or multiple dose administration.

There is no information on clinical signs and symptoms associated with an overdose of ZEVTERA. For patients who receive doses greater than the recommended dosage regimen and have unexpected adverse reactions associated with ZEVTERA, discontinue ZEVTERA, treat symptomatically, and institute general supportive treatment. ZEVTERA can be removed by hemodialysis. However, no information is available on the use of hemodialysis to treat overdose [see Clinical Pharmacology (12.3) ] .

• Apr 3, 2024NDANDA218275Istx

1. 1Epilepsy716%
2. 2Off Label Use716%
3. 3Torsade De Pointes614%
4. 4Alveolar Lung Disease512%
5. 5Gangrene512%
6. 6Pneumonia Necrotising512%
7. 7Pancytopenia37.0%
8. 8Clostridium Difficile Infection24.7%
9. 9Diarrhoea24.7%
10. 10Drug Reaction With Eosinophilia And Systemic Symptoms24.7%
11. 11Liver Injury24.7%
12. 12Myelosuppression24.7%
13. 13Pyrexia24.7%
14. 14Rash24.7%
15. 15Stevens-johnson Syndrome24.7%

The 10 most recently updated of 31 ClinicalTrials.gov registrations naming Ceftobiprole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin
  Completed · Phase 1 · Interventional · 12 enrolled · Basilea Pharmaceutica
  NCT06808646updated 2026-04-21
• Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations
  Not yet recruiting · Observational · 150 enrolled · Chinese PLA General Hospital
  NCT07494981updated 2026-03-27
• Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.
  Completed · Interventional · 12 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT04171674updated 2025-12-05
• Pathogenicity Factors of Staphylococcus Pettenkoferi in Foot Wounds and Osteitis in Diabetic Patients
  Active not recruiting · Observational · 230 enrolled · Centre Hospitalier Universitaire de Nīmes
  NCT06688084updated 2025-11-17
• Individualized Precision Therapy With Ceftobiprole Guided by PK/PD in Geriatric Populations
  Not yet recruiting · Observational · 150 enrolled · Chinese PLA General Hospital
  NCT07127185updated 2025-09-23
• Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Age
  Completed · Phase 3 · Interventional · 9 enrolled · Basilea Pharmaceutica
  NCT05856227updated 2025-07-28
• Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria
  Not yet recruiting · Interventional · 75 enrolled · Centre Hospitalier Universitaire de Nice
  NCT07058415updated 2025-07-10
• Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
  Completed · Phase 3 · Interventional · 390 enrolled · Basilea Pharmaceutica
  NCT03138733updated 2023-11-08
• Collection of Data of Ceftobiprole Treated Patients: Comparison of Patients With and Without Certain Diseases
  Completed · Observational · 428 enrolled · Advanz Pharma
  NCT04170309updated 2023-07-07
• Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
  Terminated · Phase 1 · Interventional · 15 enrolled · Basilea Pharmaceutica
  NCT02527681updated 2023-06-05

Frequently asked questions

How does Ceftobiprole work?

ZEVTERA is an antibacterial drug [see Microbiology (12.4) ]

What is Ceftobiprole used for?

According to FDA labeling, Ceftobiprole carries indications including: 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 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ceftobiprole?

Ceftobiprole is classified as Cephalosporin Antibacterial, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors, Transpeptidase Inhibitors, Decreased Cell Wall Synthesis & Repair.

What are the brand names for Ceftobiprole?

Ceftobiprole is marketed under brand names including Zevtera.

What are the contraindications for Ceftobiprole?

Ceftobiprole labeling lists contraindications including: ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class [see Warnings and Precautions (5.2) ]. ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class ( 4 ).. Always consult the full prescribing information and a clinician.