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Zevtera Dosage

Generic name: ceftobiprole medocaril sodium 667mg in 10mL
Dosage form: injection, powder, for solution

Medically reviewed by Drugs.com. Last updated on Jun 19, 2024.

Recommended Dosage and Administration for SAB, ABSSSI and CABP in Adult Patients

The recommended dosage of ZEVTERA for the treatment of adult patients with SAB, ABSSSI and CABP is described in Table 1 below. The duration of treatment in adult patients is up to 42 days for SAB and 5 days to 14 days for ABSSSI and CABP.

Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL to adult patients.

Table 1 Recommended Dosage Regimen for SAB, ABSSSI and CABP in Adult Patients

aDuration of treatment in adult patients is up to 42 days for SAB and 5 days to 14 days for ABSSSI and CABP.

b 667 mg of ceftobiprole medocaril sodium is equivalent to 500 mg of ceftobiprole.

cAdminister each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL
Indicationa Dose Frequencyc
SAB 667 mgb Every 6 hours on Days 1 to 8
Every 8 hours from Day 9
ABSSSI 667 mgb Every 8 hours
CABP 667 mgb Every 8 hours

Recommended Dosage and Administration for CABP in Pediatric Patients (3 months to less than 18 years old)

For treatment of pediatric patients with CABP, the recommended dosage of ZEVTERA is described in Table 2 below, based on patient age and weight. The duration of treatment for CABP in pediatric patients (3 months to less than 18 years old) is 7 days to 14 days.

Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL for patients 12 years to less than 18 years old and at a concentration of 5.33 mg/mL for patients greater than or equal to 3 months to less than 12 years old.

Table 2 Recommended Dosage Regimen in Pediatric Patients with CABP

aDuration of treatment for CABP in pediatric patients is 7 days to14 days.

b 13.3 mg/kg of ceftobiprole medocaril sodium is equivalent to 10 mg/kg of ceftobiprole; 20 mg/kg ceftobiprole medocaril sodium is equivalent to 15 mg/kg of ceftobiprole. 667 mg ceftobiprole medocaril sodium is equivalent to 500 mg of ceftobiprole.

c Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL for patients 12 years to less than 18 years old.

dAdminister each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration at a concentration of 5.33 mg/mL for patients greater than or equal to 3 months to less than 12 years old.
Pediatric Age Group Dosea Frequency
12 years to less than 18 years old 13.3 mg/kg (up to 667 mg/doseb) Every 8 Hoursc
3 months to less than 12 years old 20 mg/kg (up to 667 mg/doseb) Every 8 Hoursd

Recommended Dosage Regimen in Adult Patients with Renal Impairment

The recommended ZEVTERA dosage in adult patients with renal impairment (CLCR less than 50 mL/min), including patients receiving hemodialysis is shown in Table 3 below. The duration of treatment in adult patients with renal impairment is up to 42 days for SAB and 5 days to 14 days for ABSSSI and CABP.

Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL to adult patients with renal impairment.

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

Table 3 ZEVTERA Recommended Dosage Regimens for SAB, ABSSSI and CABP in Adult Patients with Renal Impairment

aDuration of treatment in adult patients is up to 42 days for SAB and 5 days to 14 days for ABSSSI and CABP.

b Based on calculated creatinine clearance.

cAdminister ZEVTERA after intermittent hemodialysis on hemodialysis days, because ceftobiprole is removed by hemodialysis.

d 667 mg ceftobiprole medocaril sodium is equivalent to 500 mg of ceftobiprole; 333 mg ceftobiprole medocaril sodium is equivalent to 250 mg of ceftobiprole

e Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL
Indicationa Creatinine Clearance, CLCR (mL/min)b Dosed Frequencye
SAB 30 to less than 50 mL/min 667 mg Every 8 hours on
Days 1 to 8
Every 12 hours from Day 9
15 to less than 30 mL/min 333 mg Every 8 hours on
Days 1 to 8
Every 12 hours from Day 9
Less than 15 mL/min, including hemodialysisc 333 mg Every 24 hours
ABSSSI or CABP 30 to less than 50 667 mg Every 12 hours
15 to less than 30 333 mg Every 12 hours
Less than 15 mL/min, including hemodialysisc 333 mg Every 24 hours

Recommended Dosage Regimen for CABP in Pediatric Patients (2 Years to Less than 18 Years Old) with Renal Impairment

The recommended dosage of ZEVTERA in pediatric patients (2 years to less than 18 years old) with renal impairment (with eGFR less than 50 mL/min/1.73 m2 and greater than or equal to 15 mL/min/1.73 m2) is shown in Table 4. The duration of treatment for CABP in pediatric patients (2 years to less than 18 years old) with renal impairment is 7 days to 14 days.

Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL for patients 12 years to less than 18 years old and at a concentration of 5.33 mg/mL for patients 2 years to less than 12 years old.

There is insufficient information to recommend dosage adjustments in pediatric patients 2 years of age and older with an eGFR less than 15 mL/min/1.73m2.

There is insufficient information to recommend dosage adjustments in pediatric patients less than 2 years of age with any degree of renal impairment.

Table 4 ZEVTERA Recommended Dosage Regimens for Pediatric Patients (2 Years to less than 18 Years Old) with CABP and with Renal Impairment

aDuration of treatment for CABP in pediatric patients (2 years to less than 18 years old) and with renal impairment is 7 days to 14 days.

bCalculate using a validated GFR estimating equation for the approved age of the pediatric population.

c 667 mg ceftobiprole medocaril sodium is equivalent to 500 mg of ceftobiprole; 333 mg ceftobiprole medocaril sodium is equivalent to 250 mg of ceftobiprole; 10 mg/kg of ceftobiprole medocaril sodium is equivalent to 7.5 mg/kg of ceftobiprole; 13.3 mg/kg ceftobiprole medocaril sodium is equivalent to 10 mg/kg of ceftobiprole

dAdminister each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL for pediatric patients 12 years to less than 18 years old.

eAdminister each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 5.33 mg/mL for pediatric patients 2 years to less than 12 years old.
Pediatric Age Groupa eGFR (mL/min/1.73 m2)b Dosage Regimenc
12 years to less than 18 years old 30 to less than 50 10 mg/kg (up to 667 mg)d every 12 hours
15 to less than 30 10 mg/kg (up to 333 mg)d every 12 hours
6 years to less than 12 years old 30 to less than 50 10 mg/kg (up to 667 mg)e every 12 hours
15 to less than 30 10 mg/kg (up to 333 mg)e every 24 hours
2 years to less than 6 years old 30 to less than 50 13.3 mg/kg every 12 hours (up to 667 mg)e
15 to less than 30 13.3 mg/kg every 24 hours (up to 333 mg)e

Preparation of ZEVTERA Infusion Solution

ZEVTERA must first be reconstituted in the vial and then further diluted prior to administration by intravenous infusion over a period of 2 hours. Aseptic technique must be followed in preparing the infusion solution. See additional instructions for reconstitution and dilution below.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution for infusion should be clear to slightly opalescent and yellowish in color. Discard if discoloration or visible particles are observed.

Reconstitution of ZEVTERA in the Vial

  • For adult and pediatric patients 12 years of age and older, reconstitute ZEVTERA lyophilized powder in the vial with 10 mL of sterile water for injection or 10 mL of 5% dextrose injection.
  • For pediatric patients aged 3 months to less than 12 years old, ZEVTERA lyophilized powder must be reconstituted with 10 mL of 5% dextrose injection.
  • After reconstitution, shake the reconstituted ZEVTERA vial vigorously until dissolution is completed, which in some cases may take up to 10 minutes. The volume of the resulting reconstituted solution is approximately 10.6 mL.
  • Allow any foam formed to dissipate, and then inspect the reconstituted solution visually to ensure the product is in solution and particulate matter is absent.
  • The reconstituted solution contains 66.7 mg/mL of ceftobiprole medocaril sodium and must be further diluted using aseptic technique with the appropriate diluent as described below, prior to administration. If it is not possible to dilute the reconstituted 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.

Dilution of Reconstituted ZEVTERA Solution and Administration of the Diluted Product

After reconstitution with the appropriate diluent, further dilute the reconstituted ZEVETRA solution, using aseptic technique with the appropriate diluent, to the appropriate volume of ZEVTERA infusion solution as described in Table 5 below.

Table 5. Preparation of Diluted ZEVTERA Solution for Infusion

a Gently invert 5-10 times to form a homogenous solution. Avoid vigorous agitation to prevent foaming.

b For administration via infusion bags, bottles, or syringes: For example, for a dose equal to 667 mg, withdraw 10 mL of the reconstituted solution from the vial and inject into a suitable container of 125 mL of infusion solution.

c For administration via a 50 mL syringe if the calculated dose does not exceed 267 mg: For example, for a dose equal to 267 mg, withdraw 4 mL of the reconstituted solution from the vial and withdraw 46 mL of the appropriate infusion solution into the syringe for infusion.
Patient Age Group Volume 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
Adult
(18 years of age and older)		 10 mL 10 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)
Adult patients with renal Impairment (CLCR less than 30 mL/min) 10 mL 5 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)
Pediatric Patients 12 Years of Age to Less than 18 Years of Age 10 mL Refer to Table 2 for the dose to determine volume of reconstituted solution needed according to weight-based dosing The final volume to be administered should be calculated based on the patient body weight and must not exceed a maximum of 250 mL of 0.9% sodium chloride or 5% dextrose injection
(do not exceed maximum of 667 mg/250 mL dose at a concentration of 2.67 mg/mL)
Pediatric Patients 12 Years of Age to Less than 18 Years of Age with renal Impairment 10 mL Renal Impairment: Refer to Table 4 for the dose to determine volume of reconstituted solution needed according to weight-based dosing The final volume to be administered should be calculated based on the patient body weight and must not exceed a maximum of 250 mL of 0.9% sodium chloride or 5% dextrose injection
(do not exceed maximum of 667 mg/250 mL dose at a concentration of 2.67 mg/mL)
Pediatric Patients 3 months to Less than 12 Years of Age 10 mL Refer to Table 2 for the dose to determine the volume of reconstituted solution needed according to weight-based dosingb,c The final volume to be administered should be calculated based on the patient body weight and must not exceed a maximum of 125 mL of 5% dextrose injection

(do not exceed maximum of 667 mg/125 mL at a concentration of 5.33 mg/mL)
Pediatric Patients 2 years to less than 12 years of age with renal impairment 10 mL Renal Impairment: Refer to Table 4 for the dose to determine the volume of reconstituted solution needed according to weight-based dosingb,c The final volume to be administered should be calculated based on the patient body weight and must not exceed a maximum of 125 mL of 5% dextrose injection

(do not exceed maximum of 667 mg/125 mL at a concentration of 5.33 mg/mL)

Storage of Reconstituted and Diluted Infusion Solutions

Storage of Reconstituted ZEVTERA Solution in Vials

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.

Storage of Diluted ZEVTERA Solution in Infusion Bags

ZEVTERA solutions for infusions can be stored at room temperature or refrigerated at 2 °C to 8 °C. If the infusion solution is stored in the refrigerator, it should be equilibrated to room temperature prior to administration. ZEVTERA solutions should not be exposed to direct sunlight. The infusion solution does not need to be protected from light during administration. Do not freeze ZEVTERA solutions for infusions.

Storage for diluted ZEVTERA infusion solutions at a concentration of 2.67 mg/mL and 5.33 mg/mL for varying storage conditions are described in Tables 6 and 7 below.

Table 6 Storage Time for Diluted ZEVTERA Infusion Solutions for Adult and Pediatric Patients 12 Years to Less than 18 Years Old (2.67 mg/mL)
Reconstitution
solution diluent (vial)		 Infusion
solution diluent		 Infusion solutions
stored at 25 °C
NOT protected from light		 Infusion solutions stored at 2 °C to 8 °C
Protected from light
5% Dextrose solution for injection 5% Dextrose
solution for injection		 6 hours 94 hours
0.9% Sodium chloride solution for injection 4 hours 24 hours
Sterile water for injection 5% Dextrose
solution for injection or
0.9% Sodium chloride solution for injection		 6 hours 94 hours
Table 7 Storage Time for Diluted ZEVTERA Infusion Solutions for Pediatric Patients Less than 12 Years Old (5.33 mg/mL)
Reconstitution
solution diluent (vial)		 Infusion
solution diluent		 Infusion solutions
stored at 25 °C
NOT protected from light		 Infusion solutions stored at 2 °C to 8 °C
Protected from light
5% Dextrose solution for injection 5% Dextrose
solution for injection		 6 hours
 24 hours

Drug Compatibilities and Incompatibilities

ZEVTERA is compatible with 5% dextrose injection and 0.9 % sodium chloride injection. The compatibility of ZEVTERA with other drugs and infusion solutions other than 5% dextrose Injection or 0.9% sodium chloride Injection, has not been established.

ZEVTERA must not be mixed or administered simultaneously with calcium-containing solutions. Do not mix ZEVTERA with, or co-administer through, the same intravenous line or cannula with other drug products.

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