Overview
11 DESCRIPTION ZEVTERA (ceftobiprole medocaril sodium for injection) contains sodium salt of ceftobiprole medocaril, a semisynthetic, cephalosporin antibacterial, for intravenous use. Chemically, ceftobiprole medocaril is (6 R ,7 R )-7-[[(2 Z )-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-hydroxyiminoacetyl]amino]-3-[( E )-[1-[(3 R...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action ZEVTERA is an antibacterial drug [see Microbiology (12.4) ] 12.2 Pharmacodynamics Ceftobiprole exposure-response relationships and the time course of pharmacodynamic response are unknown. Time Above the Minimum Inhibitory Concentration (MIC) The time that the unbound plasma concentration of ceftobiprole exceeds the MIC of Staphylococcus aureus , Streptococcus pneumoniae , and species of Enterobacterales correlates with efficacy in a neutropenic murine thigh infection model [see Clinical Pharmacology (12.4) ] . Cardiac Electrophysiology At a dose 1 to 2 times the maximum recommended dose, ZEVTERA does not prolong the QT interval to any clinically relevant extent. 12.
Indications
- 1 INDICATIONS AND USAGE ZEVTERA is a cephalosporin antibacterial indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis ( 1.1 ), Adult patients with acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 ), and Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP) ( 1.3 ).
Common Doses
- 667 mg
- 2.67 mg
- 13.3 mg
- 20 mg
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage of ZEVTERA for adult patients with SAB, ABSSSI and CABP is described in the table below ( 2.1 ): Indication in Adults Dose Frequency SAB 667 mg 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 Duration of treatment in adult patients is up to 42 days for SAB and 5 days to 14 days for ABSSSI and CABP ( 2.1 ). Administer each prepared intravenous infusion solution of ZEVTERA over 2 hours at a concentration of 2.67 mg/mL ( 2.1 , 2.6 ).
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 ).
Side Effects
- 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Increased Mortality in Ventilator-Associated Bacterial Pneumonia Patients [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Contraindications (4) and Warning and Precautions (5.2) ] Seizures and Other Central Nervous System Reactions [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS Organic Anion Transporting Polypeptide 1B1/1B3 (OATP1B1/OATP1B3) Substrates: ZEVTERA may increase the plasma concentrations of OATP1B1 and OATP1B3 substrates. Concomitant administration is not recommended ( 7.1 ) 7.1 Organic Anion Transporting Polypeptide 1B1/1B3 (OATP1B1/OATP1B3) Substrates ZEVTERA may increase the plasma concentrations of OATP1B1 and OATP1B3 substrates. Concomitant administration is not recommended [see Clinical Pharmacology (12.3) ]. 7.