Dosing & Uses
Dosage Forms & Strengths
meropenem/vaborbactam
injection, sterile powder for reconstitution
- (1g/1g)/vial: 2 g
Urinary Tract Infections
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
4 g (meropenem [2g]/vaborbactam [2g]) IV q8hr for up to 14 days; infuse over 3 hr
see Administration
Dosage Modifications
Renal impairment
- Treatment duration for all doses: Up to 14 days
- eCrCl >50 mL/min/1.73²: No dosage adjustment necessary
- eCrCl 30-49 mL/min/1.73²: 2 g (meropenem [1g]/vaborbactam [1g]) IV q8hr
- eCrCl 15-29 mL/min/1.73²: 2 g (meropenem [1g]/vaborbactam [1g]) IV q12hr
- eCrCl <15 mL/min/1.73²: 1 g (meropenem [0.5g]/vaborbactam [0.5g]) IV q12hr
- Dose adjustments for renal impairment should be administered after hemodialysis session
Dosing Considerations
Meropenem is known to be substantially excreted by the kidneys, and risk of adverse reactions may be greater in patients with renal impairment
Geriatric patients are more likely to have decreased renal function; use caution in dose selection and monitor if necessary
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious (8)
- BCG vaccine live
meropenem/vaborbactam decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.
- cholera vaccine
meropenem/vaborbactam, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.
- divalproex sodium
meropenem/vaborbactam decreases levels of divalproex sodium by unknown mechanism. Avoid or Use Alternate Drug. Risk of seizures. If administration of meropenem/vaborbactam is necessary, then supplemental anticonvulsant therapy should be considered.
- microbiota oral
meropenem/vaborbactam decreases effects of microbiota oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Microbiota oral contains bacterial spores. Antibacterial agents may decrease efficacy if coadministered. Complete antibiotic regimens 2-4 days before initiating microbiota oral. .
- probenecid
probenecid increases levels of meropenem/vaborbactam by decreasing elimination. Avoid or Use Alternate Drug. Probenecid competes withe meropenem for active tubular secretion.
- seladelpar
meropenem/vaborbactam will increase the level or effect of seladelpar by decreasing metabolism. Avoid or Use Alternate Drug. OAT3 inhibitors may increase seladelpar systemic exposure.
- typhoid vaccine live
meropenem/vaborbactam decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.
- valproic acid
meropenem/vaborbactam decreases levels of valproic acid by unknown mechanism. Avoid or Use Alternate Drug. Risk of seizures. If administration of meropenem/vaborbactam is necessary, then supplemental anticonvulsant therapy should be considered .
Monitor Closely (12)
- bazedoxifene/conjugated estrogens
meropenem/vaborbactam will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- conjugated estrogens
meropenem/vaborbactam will decrease the level or effect of conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- conjugated estrogens, vaginal
meropenem/vaborbactam will decrease the level or effect of conjugated estrogens, vaginal by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- dienogest/estradiol valerate
meropenem/vaborbactam will decrease the level or effect of dienogest/estradiol valerate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. An alternate or additional form of birth control may be advisable during concomitant use.
- digoxin
meropenem/vaborbactam will increase the level or effect of digoxin by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.
- estradiol
meropenem/vaborbactam will decrease the level or effect of estradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- estrogens conjugated synthetic
meropenem/vaborbactam will decrease the level or effect of estrogens conjugated synthetic by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- estrogens esterified
meropenem/vaborbactam will decrease the level or effect of estrogens esterified by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- estropipate
meropenem/vaborbactam will decrease the level or effect of estropipate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- mestranol
meropenem/vaborbactam will decrease the level or effect of mestranol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- sodium picosulfate/magnesium oxide/anhydrous citric acid
meropenem/vaborbactam decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.
- sulopenem etzadroxil/probenecid
meropenem/vaborbactam increases levels of sulopenem etzadroxil/probenecid by decreasing metabolism. Use Caution/Monitor. Sulopenem is a substrate of OAT3; therefore, drugs that inhibit OAT3 may increase sulopenem plasma concentrations. If coadministration is unavoidable, monitor more frequently for sulopenem adverse reactions (eg, diarrhea and nausea).
Minor (8)
- balsalazide
meropenem/vaborbactam will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- biotin
meropenem/vaborbactam will decrease the level or effect of biotin by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- niacin
meropenem/vaborbactam will decrease the level or effect of niacin by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- pantothenic acid
meropenem/vaborbactam will decrease the level or effect of pantothenic acid by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- pyridoxine
meropenem/vaborbactam will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- pyridoxine (Antidote)
meropenem/vaborbactam will decrease the level or effect of pyridoxine (Antidote) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- thiamine
meropenem/vaborbactam will decrease the level or effect of thiamine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- vitamin K1 (phytonadione)
meropenem/vaborbactam will decrease the level or effect of vitamin K1 (phytonadione) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
Adverse Effects
1-10%
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%)
>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
Contraindications
Hypersensitivity to any components of meropenem/vaborbactam, other carbapenem drugs, or patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs
Cautions
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
Hypersensitivity reactions
- Hypersensitivity reactions reported in clinical trials; serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions reported in patients receiving therapy with beta-lactam antibacterial drugs; these reactions are more likely to occur in individuals with history of sensitivity to multiple allergens
- There have been reports of individuals with history of penicillin hypersensitivity who experienced severe hypersensitivity reactions when treated with another beta-lactam antibacterial drug; before initiating therapy, important to inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactam antibacterial drugs, and other allergens; if an allergic reaction to therapy occurs, discontinue drug immediately
Seizure potential
- Seizures and other adverse CNS reactions reported; these reactions occur most commonly in patients with CNS disorders (eg, brain lesions or history of seizures) or with bacterial meningitis and/or compromised renal function
- Continue anticonvulsants in patients with known seizure disorders; if focal tremors, myoclonus, or seizures occur, evaluate neurologically, place on anticonvulsants if not already instituted, and determine if meropenem/vaborbactam dose should be decreased or discontinued
Clostridioides difficile-associated diarrhea
- Clostridioides difficile-associated diarrhea (CDAD) may occur with use of nearly all antibacterial agents, including meropenem/vaborbactam; severity ranges from mild diarrhea to fatal colitis; treatment with antibacterial agents alters normal flora of the colon, leading to overgrowth of C difficile
- C. difficile produces toxins A and B which contribute to the development of CDAD; hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy; CDAD must be considered in all patients who present with diarrhea following antibacterial drug use; careful medical history necessary since CDAD reported to occur over two months after administration of antibacterial agents
- If CDAD is suspected/confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued; appropriate management (eg, fluid/electrolyte management, protein supplementation, antibacterial drug treatment of C difficile, surgical evaluation) should be institute
Drug interactions overview
- Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem; coadministration with probenecid is not recommended
- Concomitant use of meropenem/vaborbactam with valproic acid and divalproex sodium is generally not recommended; case reports have shown that coadministration of carbapenems (eg, meropenem) to patients receiving valproic acid or divalproex sodium results in decreased valproic acid concentrations
- The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, increasing the risk of breakthrough seizures; increasing the dose of valproic acid or divalproex sodium may not be sufficient to overcome this interaction; consider administration of antibacterial drugs other than carbapenems to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium; if administration of this antibiotic is necessary, consider supplemental anticonvulsant therapy
- Consider administration of antibacterial drugs other than carbapenems to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium; if administration of meropenem/vaborbactam is necessary, consider supplemental anticonvulsant therapy
- When administering this drug concomitantly with medicinal products that are predominantly metabolized by CYP1A2, CYP3A4, CYP2C, and/or are substrates of P-gp transporters, there is a potential risk of interaction which may result in decreased plasma concentrations and activity of the co-administered drug(s)
- When concomitantly administered with the substrates of CYP1A2, CYP3A4, CYP2C, and/or P-gp, refer to the prescribing information for these concomitant medications for guidance on need for dosage adjustments and/or need for frequent drug level monitoring when administered with a weak CYP inducer(s)
- When administering concomitantly with medicinal products substrate of OAT3 transporters, there is a potential risk of interaction which may result in increased plasma concentrations and activity of the co-administered drug(s); when concomitantly administered with OAT3 substrate(s), refer to the prescribing information for these concomitant medication(s) for guidance on need for dosage adjustments and/or need for frequent drug level monitoring when administered with an OAT3 inhibitor(s)
- Use may reduce the effectiveness of hormonal contraceptives; advise patients taking hormonal contraceptives to use an effective alternative non-hormonal contraception or additional contraceptive method (eg, barrier method of contraception) during treatment
Pregnancy
Pregnancy
Human data are insufficient to establish a drug-associated risk of major birth defects or miscarriages with meropenem/vaborbactam in pregnant women
Malformations (supernumerary lung lobes, interventricular septal defect) were observed in offspring from pregnant rabbits administered vaborbactam IV during the organogenesis period at doses approximately equivalent to or above the maximum recommended human dose (MRHD) based on plasma AUC comparison; uncertain whether malformations are clinically relevant; no similar malformations or fetal toxicity were observed in offspring from pregnant rats administered vaborbactam IV during organogenesis or from late pregnancy through lactation at a dose equivalent to ~1.6 times the MRHD based on body surface area (BSA) comparison
Lactation
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
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meropenem/vaborbactam and any potential adverse effects on the breastfed child from meropenem/vaborbactam or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Meropenem: Inhibits bacterial cell wall synthesis by binding to several of the penicillin-binding proteins (PBPs), which, in turn, inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis; bacteria eventually lyse as a result of ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested
Vaborbactam: Nonsuicidal beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases (eg, Klebsiella pneumoniae carbapenemase [KPC]); vaborbactam does not have any antibacterial activity and does not decrease meropenem activity against meropenem-susceptible organisms
Absorption
Peak plasma concentration, single 4-g dose: 46 mg/L (meropenem); 50.7 mg/L (vaborbactam)
Peak plasma concentration, 4-g IV q8hr: 57.3 mg/L (meropenem); 71.3 (vaborbactam)
AUC, single 4-g dose: 24 mg·h/L (meropenem); 168 mg·h/L (vaborbactam)
AUC (steady-state), 4-g IV q8hr: 650 mg/L; 835 mg/L
Distribution
Protein bound: 2% (meropenem); 33% (vaborbactam)
Vd: 20.2 L (meropenem); 18.6L (vaborbactam)
Metabolism
Meropenem: Minor pathway for elimination is hydrolysis of the beta-lactam ring (meropenem open lactam), which accounts for 22% of a dose eliminated via the urine
Vaborbactam: Does not undergo metabolism
Elimination
Clearance: 15.1 L/hr (meropenem); 10.8 L/hr (vaborbactam)
Half-life: 1.22 hr (meropenem); 1.68 hr (vaborbactam)
Excretion, urine over 24-48 hr: 40-60% (meropenem); 75-95% (vaborbactam)
Excretion, feces: ~2% (meropenem)
Administration
IV Compatibilities
0.9% NaCl
IV Preparation
Reconstitute with 20 mL of 0.9% NaCl per vial; and then further dilute
Mixed gently to dissolve; reconstituted solution concentration equals 0.05 g/mL (meropenem) and 0.05 g/mL (vaborbactam)
Reconstituted solution must be immediately diluted further in a 0.9% NaCl infusion bag
After dilution, final infusion concentration of meropenem/vaborbactam should be 2-8 mg/mL
Visually inspect the diluted solution for particulate matter and discoloration prior to administration (the infusion solution for administration should appear colorless to light yellow); discard unused portion after use
See prescribing information for further information
IV Administration
Infuse diluted solution IV over 3 hr
Infusion must be completed within 4 hr if stored at room temperature or 22 hr if stored refrigerated at 2-8°C (36-46°F)
Storage
Unopened vial: Store at room temperature 20-25°C (68-77°F); excursions are permitted to 15-30°C (59-86°F)
Reconstituted vial/diluted solution: 4 hr at room temperature; 22 hr if refrigerated at 2-8°C (36-46°F)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Vabomere intravenous - | 2 gram vial |  |
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