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

Using ZEVTERA

Dosing regimen
for SAB in adult patients1,2

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Dosing & Administration

Dosing and administration for adult patients with SAB1,2

ZEVTERA is supplied in a single-dose vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for intravenous (IV) infusion after reconstitution.1

For adult patients (≥18 years of age) with Staphylococcus aureus bloodstream infections (SAB)1

Administer each prepared IV infusion solution at a concentration of 2.67 mg/mL over 2 hours as per the below schedule, for up to 42 days1:

Days 1‑8Every 6 hours
Day 9 OnwardsEvery 8 hours

For adult SAB patients with renal impairment1

Administer each prepared IV infusion solution at a concentration of 2.67 mg/mL to patients with renal impairment (CLCR less than 50 mL/min), including patients receiving hemodialysis, for up to 42 days1:

Slide table to view more.
Creatinine Clearance (mL/min)aZEVTERA DosecFrequencyd
30 to less than 50 mL/min667 mg

Every 8 hours on Days 1 to 8

Every 12 hours from Day 9

15 to less than 30 mL/min333 mg

Every 8 hours on Days 1 to 8

Every 12 hours from Day 9

Less than 15 mL/min, including hemodialysisb333 mgEvery 24 hours

In adult patients with augmented renal clearance (CLCR greater than 150 mL/min), increase the ZEVTERA dosage to 667 mg every 6 hours.

For more information on patient age groups, and other FDA-approved indications (ABSSSI and CABP), see the Full Prescribing Information.1

The pharmacokinetic profile of ZEVTERA is linear and time-independent.1

No clinically significant differences in the pharmacokinetics of ZEVTERA were observed in adults based on age, gender, or race/ethnicity.1

aBased on calculated creatinine clearance.1

bAdminister ZEVTERA after intermittent hemodialysis on hemodialysis days, because ZEVTERA is removed by hemodialysis.1

c667 mg ZEVTERA medocaril sodium is equivalent to 500 mg of ZEVTERA; 333 mg ZEVTERA medocaril sodium is equivalent to 250 mg of ZEVTERA.1

dAdminister each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL.1

ABSSSI, acute bacterial skin and skin structure infections; CABP, community-acquired bacterial pneumonia; CLCR, creatinine clearance; IV, intravenous.

Preparation

How to prepare

Reconstitute ZEVTERA in the vial, then further dilute the solution prior to administration by IV infusion over a period of 2 hours, following aseptic techniques.1

Visually inspect the solution for particulate matter and discoloration prior to administration. The solution should be clear to slightly opalescent and yellowish in color. Discard if discoloration or visible particles are observed.1

Reconstitution of ZEVTERA in the vial

  • Reconstitute ZEVTERA lyophilized powder in the vial with 10 mL of sterile water for injection or 10 mL of 5% dextrose injection

Dilution of reconstituted ZEVTERA solution and administration of the diluted product

After reconstitution with the appropriate diluent, further dilute the reconstituted ZEVTERA solution, using aseptic technique with the appropriate diluent, to the appropriate volume of ZEVTERA infusion solution1:

Slide table to view more.
Patient typeVolume of
diluent to be
added to the
vial		Volume of
reconstituted
solution to be
withdrawn from
the vial		Volume of
Infusion
solution to be
administereda		Concentration
and final volume
of the diluted
product
Adults (18 years of age or older)10 mL10 mL

250 mL

0.9% sodium chloride or 5% dextrose injection

2.67 mg/mL in
a 250 mL
infusion bag

(667 mg/250 mL)

Adults with renal impairment

(CLCR less than 30 mL/min)

10 mL5 mL

125 mL

0.9% sodium chloride or 5% dextrose injection

2.67 mg/mL in
a 125 mL
infusion bag

(333 mg/125 mL)

aAfter reconstitution of ZEVTERA, shake vial vigorously until dissolution is completed, up to 10 minutes. Allow any foam formed to dissipate. After further dilution, gently invert 5-10 times to form a homogeneous solution. At this step, avoid vigorous agitation to prevent foaming.

Storage

How ZEVTERA is supplied

ZEVTERA, a white, yellowish to slightly brownish sterile powder for reconstitution, supplied in a single-dose clear glass vial, sealed with a rubber stopper (not made with natural rubber latex) and an aluminum seal with a flip-off cap1

Each vial contains 667 mg of ZEVTERA medocaril sodium (equivalent to 500 mg of ZEVTERA) and is supplied in a carton containing 10 single-dose vials (NDC 68547-0578-10)1

How to store

Store ZEVTERA vials refrigerated at 2 °C to 8 °C (36 °F to 46 °F) protected from light1

Store in carton until time of use1

ZEVTERA must be reconstituted and then further diluted prior to administration by intravenous infusion1

  • Upon reconstitution with the appropriate diluent, the reconstituted ZEVTERA solution in the vial should be transferred and diluted into the appropriate container
  • If it is not possible to dilute the reconstituted ZEVTERA solution immediately, the reconstituted solution may be stored refrigerated for up to 24 hours, and at room temperature for up to 1 hour.
  • Discard any unused reconstituted solution.

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It's Clear...

...Achieve rapid bloodstream clearance rates* with ZEVTERA.1,2

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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.1,2

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.