VABOMERE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VABOMERE (VABOMERE).
Vabomere is a combination of meropenem, a carbapenem antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs), and vaborbactam, a beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases, including extended-spectrum beta-lactamases (ESBLs) and Klebsiella pneumoniae carbapenemase (KPC).
| Metabolism | Meropenem is primarily metabolized by hydrolysis of the beta-lactam ring to form an inactive ring-opened metabolite; vaborbactam is minimally metabolized with no major metabolites identified. |
| Excretion | Vabomere (meropenem and vaborbactam) is primarily excreted renally. Approximately 40-50% of meropenem and 75-95% of vaborbactam are excreted unchanged in urine. Biliary/fecal excretion is minimal (<2% for both). |
| Half-life | The terminal elimination half-life is approximately 1 hour for meropenem and 2 hours for vaborbactam in patients with normal renal function. This short half-life supports three-times-daily dosing in patients with creatinine clearance ≥50 mL/min. |
| Protein binding | Meropenem is approximately 2% protein-bound; vaborbactam is approximately 33% protein-bound (primarily to albumin). |
| Volume of Distribution | Volume of distribution is approximately 0.3 L/kg for meropenem and 0.2 L/kg for vaborbactam, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Bioavailability is 100% via intravenous administration; no oral formulation is available. |
| Onset of Action | For intravenous administration, clinical effect is expected within the first few hours following infusion, based on rapid bactericidal activity and achievement of plasma concentrations above the MIC. |
| Duration of Action | The duration of action corresponds to the dosing interval (every 8 hours) with continuous bactericidal activity while plasma concentrations exceed the MIC. Prolonged infusion may optimize time above MIC for resistant pathogens. |
Vabomere (meropenem and vaborbactam) 4 g (meropenem 2 g and vaborbactam 2 g) intravenously every 8 hours infused over 3 hours.
| Dosage form | POWDER |
| Renal impairment | For CrCl ≥50 mL/min: 4 g every 8 hours. CrCl 30-49 mL/min: 2.5 g every 8 hours. CrCl 15-29 mL/min: 2 g every 12 hours. CrCl <15 mL/min: 1 g every 12 hours. For hemodialysis: administer after dialysis; 1 g every 12 hours. |
| Liver impairment | No dose adjustment recommended for hepatic impairment. Safety and efficacy in patients with severe hepatic impairment (Child-Pugh C) not established. |
| Pediatric use | Safety and efficacy in pediatric patients (<18 years) not established. |
| Geriatric use | No specific geriatric dose adjustment; select dose based on renal function due to age-related decline in creatinine clearance. Monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VABOMERE (VABOMERE).
| Breastfeeding | It is not known whether meropenem or vaborbactam are excreted in human milk. Meropenem is excreted in rat milk at low concentrations. Caution should be exercised when Vabomere is administered to a nursing woman. The M/P ratio is unknown. |
| Teratogenic Risk | Vabomere (meropenem and vaborbactam) is classified as Pregnancy Category B. Animal reproduction studies in rats and rabbits at up to 3 times the human dose based on AUC showed no evidence of fetal harm. However, there are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, Vabomere should be used during pregnancy only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to meropenem, vaborbactam, or any component of the product, or to other carbapenem antibiotics.","Patients who have demonstrated anaphylactic reactions to beta-lactam antibiotics."]
| Precautions | ["Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving beta-lactams; prior to therapy, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins, carbapenems, or other beta-lactams.","Seizures and other adverse CNS effects have been reported; use with caution in patients with CNS disorders (e.g., brain lesions, history of seizures) or compromised renal function.","Clostridioides difficile-associated diarrhea (CDAD) has been reported; evaluate if diarrhea occurs.","Reduced efficacy in patients with baseline creatinine clearance (CrCl) of 30-49 mL/min; monitor renal function and adjust dose accordingly.","Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome have been reported; discontinue if signs and symptoms occur."] |
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| Fetal Monitoring | Monitor renal function, hepatic function, and complete blood count (CBC) with differential periodically. Observe for signs of hypersensitivity reactions, Clostridioides difficile-associated diarrhea, and seizures. In pregnant women, standard prenatal monitoring including fetal ultrasound if indicated. |
| Fertility Effects | No human data on fertility effects. Animal studies (rats) showed no impairment of fertility or reproductive performance at meropenem doses up to 1000 mg/kg/day (approximately 3.2 times the recommended human dose based on body surface area). Vaborbactam has not been studied for fertility effects. |