Classes
DEA Class; Rx
Common Brand Names; Vabomere
- Carbapenems
Description
Combination of meropenem, a carbapenem antibacterial, and vaborbactam, a beta-lactamase inhibitor
Used for complicated urinary tract infections (cUTIs) including pyelonephritis in adults caused by susceptible E. coli, K. pneumoniae, and E. cloacae
Activity against meropenem-resistant organisms, including KPC-producing Enterobacteriaceae
Indications
Indicated for complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex in adults ≥18 years
Contraindications
Hypersensitivity to any components of meropenem/vaborbactam, other carbapenem drugs, or patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs
Adverse Effects
- Headache (8.8%)
- Phlebitis/infusion site reactions (4.4%)
- Diarrhea (3.3%)
- Hypersensitivity (1.8%)
- Nausea (1.8%)
- Increased ALT (1.8%)
- Increased AST (1.5%)
- Pyrexia (1.5%)
- Hypokalemia (1.1%)
- Leukopenia
- Chest discomfort
- Pharyngitis
- Vulvovaginal candidiasis
- Oral candidiasis
- Creatinine phosphokinase increase
- Decreased appetite
- Hyperkalemia
- Hyperglycemia
- Hypoglycemia
- Dizziness
- Tremor
- Paresthesia
- Lethargy
- Hallucination
- Insomnia
- Azotemia
- Renal impairment
- Deep vein thrombosis
- Hypotension
- Vascular pain
Warnings
Hypersensitivity reactions reported; inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactam antibacterial drugs, and other allergens prior initiating treatment; if an allergic reaction occurs, discontinue meropenem/vaborbactam immediately; see Contraindications
Thrombocytopenia may occur in renally impaired patients; no clinical bleeding has been reported
Potential for neuromotor impairment; alert outpatients regarding possible adverse reactions (eg, seizures, delirium, headaches, paresthesias) that could interfere with mental alertness and/or cause motor impairment; advise patients not to operate machinery or motorized vehicles
To reduce the development of drug-resistant bacteria and to maintain the effectiveness, only prescribe to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
Prolonged use may result in overgrowth of nonsusceptible organisms; repeat evaluation; if superinfection does occur during therapy, appropriate measures should be taken
Pregnancy and Lactation
Human data are insufficient to establish a drug-associated risk of major birth defects or miscarriages with meropenem/vaborbactam in pregnant women
Meropenem reported to be excreted in human milk; unknown whether vaborbactam is excreted in human milk
No information is available on the effects of meropenem/vaborbactam on the breastfed child or on milk production
Maximum Dosage
12 g/day (6 g meropenem and 6 g vaborbactam) IV.
12 g/day (6 g meropenem and 6 g vaborbactam) IV.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Meropenem/vaborbactam
injection, sterile powder for reconstitution
- (1g/1g)/vial: 2 g