Zevtera (Ceftobiprole medocaril sodium) – SAB,ABSSSI,CABP

Zevtera Application Scope

Zevtera (ceftobiprole medocaril sodium) is a fifth-generation cephalosporin antibiotic administered intravenously, exhibiting broad-spectrum activity against both Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) .

Characteristics

• Ingredients: Ceftobiprole medocaril sodium

• Properties: Zevtera is a fifth-generation cephalosporin antibiotic with rapid bactericidal activity against a broad spectrum of Gram-positive bacteria

• Packaging Specification: Supplied as a carton containing 10 vials. Each vial contains 667 mg of ceftobiprole medocaril sodium

• Storage:

  • Store unreconstituted vials under refrigeration

  • Once reconstituted, the solution should be used immediately

  • Stored refrigerated at 2°C to 8°C for up to 24 hours or at room temperature for up to 1 hour

  • Discard any unused reconstituted solution

• Expiry Date: Refer to the expiration date printed on the packaging

• Executive Standard: ​Refer to the prescribing information provided by the manufacturer

• Approval Number: Approved by the U.S. FDA on April 3, 2024.

• Date of Revision: ​Refer to the latest revision date on the prescribing information.

• Manufacturer: Basilea Pharmaceutica Ltd.

Guidelines for the Use of Zevtera

• Dosage and Administration:

  • Administered by intravenous infusion over 2 hours.
  • The recommended dosage for adults with normal renal function is 667 mg every 8 hours
  • Dosage adjustments are necessary for patients with impaired renal function

• Adverse Reactions: Common adverse reactions include nausea, vomiting, diarrhea, headache, hepatic enzyme elevations, rash, anemia, hypokalemia, and infusion site reactions.

• Contraindications: Known hypersensitivity to ceftobiprole, other cephalosporins, or any component of Zevtera

• Precautions:

  • Use with caution in patients with a history of seizures or other central nervous system disorders.

  • Monitor for signs of Clostridioides difficile-associated diarrhea

  • Not approved for use in ventilator-associated bacterial pneumonia due to increased mortality observed in clinical trials

Interactions

• Drug Interactions:

  • Zevtera may increase plasma concentrations of OATP1B1 and OATP1B3 substrates, such as statins, enalapril, valsartan, and certain chemotherapy agents.

  • Concomitant administration with calcium-containing solutions is not recommended.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.