ZEVTERA (ceftobiprole medocaril)

There are 3 contraindications. These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.

Drug Interaction	Drug Names
Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)	VIVOTIF
Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores.	VOWST
Fecal Microbiota/Antibiotics SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Fecal microbiota is a suspension of live bacteria, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota. Antibacterial treatment should be completed for 24 to 72 hours before initiating treatment with fecal microbiota. Do not use antibiotics for up to 8 weeks after fecal microbiota.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota.	REBYOTA

Drug contraindication overview.

*Known serious hypersensitivity to ceftobiprole or other cephalosporins.

Adverse reaction overview.

Adverse effects occurring in >=4% of adult patients receiving ceftobiprole medocaril for the treatment of bacteremia and endocarditis include anemia, nausea, hypokalemia, vomiting, increased hepatic enzyme and bilirubin concentrations, diarrhea, increased serum creatinine concentrations, hypertension, leukopenia, and pyrexia. Adverse effects occurring in >=2% of adult patients receiving ceftobiprole medocaril for the treatment of acute bacterial skin and skin structure infections include nausea, diarrhea, headache, injection site reactions, increased hepatic enzyme concentrations, rash, vomiting, and dysgeusia. Adverse effects occurring in >=2% of adult patients receiving ceftobiprole medocaril for the treatment of community-acquired pneumonia include nausea, increased hepatic enzyme concentrations, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Adverse effects occurring in >=2% of pediatric patients 3 months to <18 years of age receiving ceftobiprole medocaril for the treatment of community-acquired pneumonia include vomiting, headache, increased hepatic enzyme concentrations, diarrhea, infusion site reactions, phlebitis, and pyrexia.

Safety and efficacy of ceftobiprole medocaril for the treatment of community-acquired pneumonia (CAP) in pediatric patients 3 months to <18 years of age have been established based on the safety and efficacy of the drug in adults. In addition, use of ceftobiprole in pediatric patients with CAP is supported by pharmacokinetic, safety, and efficacy data from pediatric trials. Safety and efficacy of ceftobiprole medocaril have not been established for the treatment of CAP in pediatric patients <3 months of age.

Safety and efficacy of ceftobiprole medocaril have not been established for the treatment of acute bacterial skin and skin structure infections or bacteremia with or without endocarditis in pediatric patients. In pediatric patients <18 years of age with normal renal function, no clinically important differences in the pharmacokinetics of ceftobiprole were observed compared with adults.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None