Ceftobiprole medocaril
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Cephalosporin Antibacterial
Dosing in kidney impairment
Recommended Dosage Regimen in Adult Patients with Renal Impairment The recommended ZEVTERA dosage in adult patients with renal impairment (CL CR less than 50 mL/min), including patients receiving hemodialysis is shown in Table 3. 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 [see Dosage and Administration ]. In adult patients with augmented renal clearance (CL CR greater than 150 mL/min), increase the ZEVTERA dosage to 667 mg every 6 hours. [See table below.] 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 hemodialysis 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 m 2 and greater than or equal to 15 mL/min/1.73 m 2 ) 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/1.73m 2 . There is insufficient information to recommend dosage adjustments in pediatric patients less than 2 years of age with any degree of renal impairment. [See table below.]
| IndicationDuration of treatment in adult patients is up to 42 days for SAB and 5 days to 14 days for ABSSSI and CABP. | Creatinine Clearance, CLCR (mL/min)Based on calculated creatinine clearance [see Use in Specific Populations (8.6)]. | Dose667 mg ceftobiprole medocaril sodium is equivalent to 500 mg of ceftobiprole; 333 mg ceftobiprole medocaril sodium is equivalent to 250 mg of ceftobiprole. | FrequencyAdminister each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL [see Dosage and Administration (2.5)]. |
|---|---|---|---|
| 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 hemodialysisAdminister ZEVTERA after intermittent hemodialysis on hemodialysis days, because ceftobiprole is removed by hemodialysis. | 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 hemodialysis | 333 mg | Every 24 hours |
| Pediatric Age GroupDuration 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. | eGFR (mL/min/1.73 m2)Calculate using a validated GFR estimating equation for the approved age of the pediatric population. | Dosage Regimen667 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. |
|---|---|---|
| 12 years to less than 18 years old | 30 to less than 50 | 10 mg/kg (up to 667 mg)Administer 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 [see Dosage and Administration (2.5)]. every 12 hours |
| 15 to less than 30 | 10 mg/kg (up to 333 mg) every 12 hours | |
| 6 years to less than 12 years old | 30 to less than 50 | 10 mg/kg (up to 667 mg)Administer 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 [see Dosage and Administration (2.5)]. every 12 hours |
| 15 to less than 30 | 10 mg/kg (up to 333 mg) 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) |
| 15 to less than 30 | 13.3 mg/kg every 24 hours (up to 333 mg) |
| 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 administeredGently invert 5-10 times to form a homogenous solution. Avoid vigorous agitation to prevent foaming. | 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 dosingFor 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.,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. | 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 dosing, | 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) | |
Preparation and administration
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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. 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 [see Dosage and Administration ]. [See table below.] from Day 9 ABSSSI 667 mg Every 8 hours CABP 667 mg 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, based on patient age and weight [see Clinical Pharmacology ] . 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 [see Dosage and Administration ]. [See table below.] 3 months to less than 12 years old 20 mg/kg (up to 667 mg/dose ) Every 8 Hours Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 5.33 mg/mL for patients greater than or equal to 3 months to less than 12 years old [see Dosage and Administration ].
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 [see Dosage and Administration ] . 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. [See table below.] 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 dosing , 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. [See table below.] 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 [See table below.]
Drug Compatibilities and Incompatibilities ZEVTERA is compatible with 5% dextrose injection and 0.9 % sodium chloride injection [see Dosage and Administration ]. 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.
| IndicationDuration of treatment in adult patients is up to 42 days for SAB and 5 days to 14 days for ABSSSI and CABP. | Dose | FrequencyAdminister each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL [see Dosage and Administration (2.5)] |
|---|---|---|
| SAB | 667 mg667 mg of ceftobiprole medocaril sodium is equivalent to 500 mg of ceftobiprole. | 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 |
| Pediatric Age Group | DoseDuration of treatment for CABP in pediatric patients is 7 days to 14 days. | Frequency |
|---|---|---|
| 12 years to less than 18 years old | 13.3 mg/kg (up to 667 mg/dose13.3 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. ) | Every 8 HoursAdminister 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 [see Dosage and Administration (2.5)]. |
| 3 months to less than 12 years old | 20 mg/kg (up to 667 mg/dose) | Every 8 HoursAdminister each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 5.33 mg/mL for patients greater than or equal to 3 months to less than 12 years old [see Dosage and Administration (2.5)]. |
| Pediatric Age GroupDuration 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. | eGFR (mL/min/1.73 m2)Calculate using a validated GFR estimating equation for the approved age of the pediatric population. | Dosage Regimen667 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. |
|---|---|---|
| 12 years to less than 18 years old | 30 to less than 50 | 10 mg/kg (up to 667 mg)Administer 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 [see Dosage and Administration (2.5)]. every 12 hours |
| 15 to less than 30 | 10 mg/kg (up to 333 mg) every 12 hours | |
| 6 years to less than 12 years old | 30 to less than 50 | 10 mg/kg (up to 667 mg)Administer 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 [see Dosage and Administration (2.5)]. every 12 hours |
| 15 to less than 30 | 10 mg/kg (up to 333 mg) 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) |
| 15 to less than 30 | 13.3 mg/kg every 24 hours (up to 333 mg) |
Drug interactions
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- Ceftobiprole medocaril
Label text (2 paragraphs)
7 DRUG INTERACTIONS
7.1 Drug-Laboratory Test Interactions Dipstick Tests ZEVTERA may result in false-positive results in dipstick tests (urine protein, ketones, or occult blood). Use alternate clinical laboratory methods of testing to confirm positive tests. Serological Testing Treatment with ZEVTERA has the potential to interfere with serological testing, such as the Coombs test. In clinical studies there was no evidence of hemolytic anemia in adults or children. However, the possibility that hemolytic anemia may occur cannot be ruled out. Patients experiencing anemia during or after treatment should be investigated for this possibility.
Contraindications
4 CONTRAINDICATIONS 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 ).
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for ceftobiprole medocaril. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
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 ).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Pregnant rats administered ceftobiprole medocaril intravenously at doses up to 360 mg/kg/day (approximately 1.4 times the MRHD based on total body surface area (BSA)-normalized comparisons) during organogenesis on gestation days (GD) 6 to 17 showed no adverse fetal development effects.
Maternal body weight gain and food consumption were slightly decreased at 360 mg/kg/day. Pregnant cynomolgus monkeys were administered ceftobiprole medocaril intravenously at doses up to 120 mg/kg/day (approximately 0.9 times the MRHD based on BSA comparison) during organogenesis (GD 20 to 50). Maternal body weight gain and food consumption were slightly reduced at 120 mg/kg/day. This dose was associated with a slight increase in abortion rate (approximately 10% above historical controls). No other fetal development adverse effects (i.e., no fetal malformations) were observed…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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