meropenem and vaborbactam

ATC code

J01DH52

Therapeutic class

Antibacterials for systemic use · Carbapenem combined with a beta-lactamase inhibitor

Forms

1 g/1 g meropenem/vaborbactam vials for IV infusion

Brand names

Vaborem (ES)

Overall confidence

high

Regulatory sources consulted

Approved indications

Complicated urinary and intra-abdominal infections, hospital-acquired pneumonia including ventilator-associated pneumonia, related bacteremia, and other gram-negative infections with limited options.

Contraindications

Absolute

Hypersensitivity to meropenem, vaborbactam, or other carbapenems, or a history of a severe immediate reaction to another beta-lactam.

Clinical warnings

Major warning · Severe hypersensitivity or anaphylaxis may occur; review beta-lactam allergy history and discontinue if an allergic reaction develops. — CIMA/AEMPS, ficha técnica 1181334001
Major warning · Clostridioides difficile-associated diarrhea and colitis may occur during or after treatment; assess significant diarrhea. — CIMA/AEMPS, ficha técnica 1181334001
Major warning · Seizures have been reported with meropenem/vaborbactam; risk is increased with central nervous system disorders or renal impairment. Adjust dosing and monitor. — CIMA/AEMPS, ficha técnica 1181334001

Drug interactions

HighValproic acid and valproate
Mechanism: Carbapenems rapidly and markedly lower valproate concentrations, risking loss of seizure control.
Recommendation: Avoid the combination; consider another antibacterial or anticonvulsant. Level monitoring alone may be insufficient.
CIMA/AEMPS, ficha técnica 1181334001
ModerateProbenecid
Mechanism: Probenecid increases exposure by reducing renal elimination.
Recommendation: Avoid the combination when advised by the label or monitor for adverse reactions.
CIMA/AEMPS, ficha técnica 1181334001
ModerateOral contraceptives
Mechanism: Meropenem may reduce contraceptive concentrations and effectiveness.
Recommendation: Use an alternative contraceptive method during treatment and for 28 days after the last dose.
CIMA/AEMPS, ficha técnica 1181334001

Adverse events

Common (≥1%)

Nausea, diarrhea, and rash

Rare but serious

Anaphylaxis, C. difficile colitis, and severe cytopenias

Pregnancy and lactation

During pregnancy, use only when clinically indicated. Assess breastfeeding according to milk exposure and the infant’s condition described in the product information.