ceftobiprole medocaril sodium: clinical use

Prescribing considerations

• Confirm the pneumonia indication and obtain microbiology specimens where appropriate; use susceptibility results and antimicrobial stewardship principles.
• Do not initiate for ventilator-associated pneumonia. Reassess carefully if ventilation becomes necessary after treatment begins.
• Assess renal function before and during treatment; exposure increases with renal impairment and ceftobiprole is haemodialysable.
• Correct hypovolaemia and maintain adequate urine output.
• Exercise caution with pre-existing seizure disorders and in severely immunocompromised, neutropenic or myelosuppressed patients because experience is limited.
• Review intravenous-line compatibility, particularly calcium-containing solutions and listed Y-site incompatibilities.

Contraindications and cautions

• Hypersensitivity to ceftobiprole medocaril sodium or any excipient.
• Hypersensitivity to cephalosporin antibacterials.
• Previous immediate and severe hypersensitivity to another beta-lactam antibacterial, such as a penicillin or carbapenem.

Monitoring

• Renal function and hydration status; use an enzymatic serum-creatinine assay because the Jaffé method may give falsely high results.
• Clinical response, microbiology and emergence of non-susceptible organisms or fungal superinfection.
• Hypersensitivity, neurological symptoms, infusion-site reactions and diarrhoea during or after treatment.
• Blood counts and haemolysis investigations when clinically indicated; cephalosporins may cause direct antiglobulin test seroconversion.
• Use an enzymatic urine-glucose method if testing is needed because copper-reduction tests may be affected.

Clinical pharmacology

Ceftobiprole medocaril sodium is rapidly converted by plasma esterases to ceftobiprole. The active beta-lactam binds key penicillin-binding proteins, including PBP2a in MRSA. Protein binding and metabolism are low, and elimination is mainly as unchanged active ceftobiprole through the kidneys; antibacterial activity correlates with time above the organism's minimum inhibitory concentration.

Formulation and product differences

• The UK product is a single-use powder for concentrate for intravenous infusion requiring reconstitution and further dilution.
• Preparation and final infusion concentration differ between younger children and patients aged 12 years or over; follow the product-specific preparation instructions.
• Each vial contains sodium, which may matter when total sodium intake is clinically relevant.

Solution for infusion

Route: Intravenous

Strengths: 500 mg