ZEVTERA (ceftobiprole medocaril sodium for injection) for HCPs home page

For adult patients with Staphylococcus aureus bacteremia (SAB), including right‑sided infective endocarditis

It's
Clear...

...Achieve rapid bloodstream clearance* with ZEVTERA—the only FDA-approved cephalosporin for the treatment of SAB, including MRSA bacteremia1,2

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*Based on data from the ERADICATE trial, a Phase 3, randomized, double-blind, noninferiority study comparing ZEVTERA with daptomycin ± aztreonam in patients with complicated SAB. The median time to bloodstream clearance was 4 days in both groups.1,3

WHY ZEVTERA

ZEVTERA—the only FDA-approved cephalosporin for the treatment of SAB in adults, including MRSA bacteremia and cases with right-sided infective endocarditis1,2

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MRSA, methicillin-resistant Staphylococcus aureus; SAB, Staphylococcus aureus bacteremia.

EFFICACY

Overall success in a Phase 3 clinical trial1,3,*,†

In ERADICATE—one of the largest, double-blind, randomized, controlled Phase 3 registrational studies in adults with SAB—ZEVTERA achieved noninferiority for overall success compared to daptomycin ± aztreonam in the ERADICATE trial (modified ITT population) at the post-treatment visit.1,3,*,†

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*Overall success was defined as survival, symptom improvement, SAB clearance, absence of new SAB-related complications, and no use of other potentially effective antibiotics at the post-treatment evaluation visit.1

†70 days post-randomization in the mITT population, as assessed by the independent DRC.

DRC, data review committee; ITT, intention-to-treat; mITT, modified intention-to-treat.

Safety

ZEVTERA—consistent safety and tolerability1,a

The safety of ZEVTERA has been evaluated in 835 adult patients across three Phase 3 clinical trials (including ABSSSI and CABP).1

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aIn patients treated with ZEVTERA, the most common adverse reactions leading to discontinuation were nausea, vomiting, rash, and urticaria, each occurring in 2/191 (1%). Deaths occurred in 17/191 (8.9%) patients treated with ZEVTERA and 18/198 (9.1%) patients treated with daptomycin ± aztreonam.1

ABSSSI, acute bacterial skin and skin structure infections; CABP, community-acquired bacterial pneumonia.

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It's Clear...

...Achieve rapid bloodstream clearance rates* with ZEVTERA.1,3

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*Based on data from the ERADICATE trial, a Phase 3, randomized, double-blind, noninferiority study comparing ZEVTERA with daptomycin ± aztreonam in patients with complicated SAB. The median time to bloodstream clearance was 4 days in both groups.1,3

INDICATIONS & USAGE

Indications

ZEVTERA® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of:

  • Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.
  • 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.
  • Adult and pediatric patients (3 months to less than 18 years) 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.

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.

Important Safety Information

Contraindications:

ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class.

Warnings and Precautions:

  • 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.
  • Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment.
  • Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued.
  • Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed.

Adverse Reactions:

  • SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea.
  • ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia.

  • 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.
    • 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:

Innoviva Specialty Therapeutics, Inc.™ 1‑800‑651‑3861 medinfo@istx.com

U.S. Food and Drug Administration 1‑800‑FDA‑1088 www.fda.gov/medwatch

Before administering, please see the Full Prescribing Information for ZEVTERA.