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Meropenem and vaborbactam: Drug information

Meropenem and vaborbactam: Drug information
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For additional information see "Meropenem and vaborbactam: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Vabomere
Pharmacologic Category
  • Antibiotic, Carbapenem;
  • Beta-Lactamase Inhibitor
Dosing: Adult

Dosage guidance:

Dosing: Dosage recommendations are expressed as grams of meropenem/vaborbactam combination.

Carbapenem-resistant Enterobacterales infection

Carbapenem-resistant Enterobacterales infection (eg, hospital-acquired or ventilator-associated pneumonia, bloodstream infection, or complicated intra-abdominal infection) (off-label use): IV: 4 g every 8 hours. Duration depends on site and severity of infection (Ref).

Urinary tract infection, complicated

Urinary tract infection, complicated (pyelonephritis or urinary tract infection with systemic signs/symptoms):

Note: Reserve for patients with or at risk for extensively drug-resistant pathogens (nonsusceptible to ≥1 agent in all but 2 or fewer antimicrobial classes) (eg, carbapenem-resistant Enterobacterales) (Ref).

IV: 4 g every 8 hours (Ref). Switch to an appropriate oral regimen once symptoms improve, if culture and susceptibility results allow. Total duration of therapy ranges from 5 to 14 days; for patients with symptomatic improvement within the first 48 to 72 hours of therapy, some experts recommend shorter courses of 5 to 10 days (or 7 to 10 days if therapy is completed with meropenem/vaborbactam) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Estimation of renal function for the purpose of meropenem/vaborbactam dosing may be done using the Modification of Diet in Renal Disease (MDRD) formula (manufacturer's labeling). Dosage recommendations are expressed as grams of meropenem/vaborbactam combination.

Altered kidney function:

eGFR ≥50 to 130 mL/minute/1.73 m2: IV: No dosage adjustment necessary.

eGFR 30 to 49 mL/minute/1.73 m2: IV: 2 g every 8 hours.

eGFR 15 to 29 mL/minute/1.73 m2: IV: 2 g every 12 hours.

eGFR <15 mL/minute/1.73 m2: IV: 1 g every 12 hours.

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

IV: 4 g every 8 hours (Ref).

Hemodialysis, intermittent (thrice weekly): Dialyzable (meropenem: 38%; vaborbactam: 53%) (Ref):

IV: 1 g every 12 hours; when scheduled doses fall on dialysis days, administer one of the two doses after the hemodialysis session (Ref).

Peritoneal dialysis: Likely to be dialyzable (low Vd, low protein binding) (Ref):

IV: 1 g every 12 hours (Ref).

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) and minimal residual kidney function unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection). Close monitoring of response and adverse reactions (eg, CNS effects including seizures) due to drug accumulation is important.

IV: 2 g every 8 hours (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection). Close monitoring of response and adverse reactions (eg, CNS effects including seizures) due to drug accumulation is important.

IV: 2 g every 12 hours; when scheduled doses fall on PIRRT days, administer one of the two doses after PIRRT session (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely because hepatic disease does not affect pharmacokinetics of meropenem and vaborbactam does not undergo hepatic elimination.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reactions may not be exclusive to meropenem and vaborbactam. Some patients in this study were switched to levofloxacin after 15 doses of meropenem and vaborbactam.

Also see Meropenem.

1% to 10%:

Cardiovascular: Phlebitis (≤4%)

Endocrine & metabolic: Hypokalemia (1%)

Gastrointestinal: Diarrhea (3%), nausea (2%)

Hepatic: Increased serum alanine aminotransferase (2%), increased serum aspartate aminotransferase (2%)

Hypersensitivity: Hypersensitivity reaction (2%)

Local: Infusion-site reaction (≤4%)

Nervous system: Headache (9%)

Miscellaneous: Fever (2%)

<1%:

Cardiovascular: Chest discomfort, deep vein thrombosis, hypotension

Endocrine & metabolic: Hyperglycemia, hyperkalemia, hypoglycemia

Gastrointestinal: Decreased appetite, oral candidiasis

Genitourinary: Azotemia, vulvovaginal candidiasis

Hematologic & oncologic: Leukopenia

Nervous system: Dizziness, hallucination, insomnia, lethargy, pain (vascular), paresthesia, tremor

Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen

Renal: Kidney impairment

Respiratory: Pharyngitis

Frequency not defined: Gastrointestinal: Clostridioides difficile-associated diarrhea

Contraindications

Hypersensitivity to meropenem, vaborbactam, other carbapenems or beta-lactamase inhibitors, or any component of the formulation; patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial agents.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis and serious skin reactions, have been reported with beta-lactam antibacterial agents. Risk may be increased in patients with history of sensitivity to multiple allergens; inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactam antibacterials, and other allergens prior to treatment initiation. Discontinue use if an allergic reaction occurs.

• CNS effects: Associated with CNS adverse effects, including seizures; use with caution in patients with CNS disorders (eg, brain lesions, history of seizures) or with bacterial meningitis and/or compromised renal function. Closely adhere to recommended dosing, especially in patients with risk factors for seizures. Patients who develop focal tremors, myoclonus, or seizures should undergo neurological evaluation and may require dosage adjustment or discontinuation of treatment. Outpatient use may result in paresthesias, seizures, delirium and/or headaches that can impair neuromotor function and alertness; patients should not operate machinery or drive until it is established that meropenem and vaborbactam is well tolerated.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required in patients with creatinine clearance <50 mL/minute. Increased seizure risk and thrombocytopenia have been reported in patients with renal impairment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Vabomere: 2 g: Meropenem 1 g and vaborbactam 1 g (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Vabomere Intravenous)

2 (1-1) g (per each): $267.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Administer by IV infusion over 3 hours.

Use: Labeled Indications

Urinary tract infection, complicated (pyelonephritis or urinary tract infection with systemic signs/symptoms): Treatment of complicated urinary tract infection, including pyelonephritis, caused by susceptible Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex in patients ≥18 years of age.

Use: Off-Label: Adult

Carbapenem-resistant Enterobacterales infection

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification

BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Fexinidazole: May increase serum concentration of OAT1/3 Substrates (Clinically Relevant). Management: Avoid use of fexinidazole with OAT1/3 substrates when possible. If combined, monitor for increased OAT1/3 substrate toxicities. Risk D: Consider Therapy Modification

Hormonal Contraceptives: Vaborbactam may decrease serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing meropenem/vaborbactam to ensure contraceptive reliability. Risk D: Consider Therapy Modification

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Leflunomide: May increase serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Nitisinone: May increase serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor

Pretomanid: May increase serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor

Probenecid: May increase serum concentration of Meropenem. Risk X: Avoid

Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification

Taurursodiol: May increase serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk X: Avoid

Teriflunomide: May increase serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor

Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification

Vadadustat: May increase serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor

Valproic Acid and Derivatives: Carbapenems may decrease serum concentration of Valproic Acid and Derivatives. Management: Concurrent use of carbapenem antibiotics with valproic acid is generally not recommended. Alternative antimicrobial agents should be considered, but if a concurrent carbapenem is necessary, consider additional anti-seizure medication. Risk D: Consider Therapy Modification

Reproductive Considerations

The effectiveness of hormonal contraceptives may be reduced when used with meropenem/vaborbactam. An alternative nonhormonal contraceptive or additional contraceptive method (eg, barrier method) is recommended during treatment. Consult drug interactions database for more detailed information specific to use of meropenem/vaborbactam and specific contraceptives.

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination; adverse events were observed in animal reproduction studies following administration of the vaborbactam component.

Also refer to the meropenem monograph for additional information.

Breastfeeding Considerations

Meropenem is present in breast milk; excretion of vaborbactam is not known.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother

Also refer to the meropenem monograph for additional information.

Dietary Considerations

Some products may contain sodium.

Monitoring Parameters

Monitor for signs of hypersensitivity reaction, including anaphylaxis and serious skin reactions. Periodically monitor renal function; in patients with changing renal function, monitor serum creatinine and eGFR at least daily.

Mechanism of Action

Meropenem: Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins, which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis; bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested

Vaborbactam is a beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases (eg, K. pneumonia carbapenemase [KPC]). Vaborbactam does not have antibacterial activity.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: Meropenem: 20.2 L; Vaborbactam: 18.6 L

Protein binding: Meropenem: ~2%; Vaborbactam: ~33%

Metabolism: Meropenem: Hydrolysis of beta-lactam bond to open lactam form (minor); Vaborbactam: Not metabolized

Half-life elimination: Meropenem: 1.22 hours; Vaborbactam: 1.68 hours

Excretion: Meropenem: Urine (40% to 60% [unchanged]; 22% inactive hydrolysis product); feces (~2%); Vaborbactam: Urine (75% to 95% [unchanged])

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Meropenem AUC ratios to subjects with normal renal function are 1.28, 2.07, and 4.63 for subjects with mild (eGFR 60 to 89 mL/minute/1.73 m2), moderate (eGFR 30 to 59 mL/minute/1.73 m2), and severe (eGFR <30 mL/minute/1.73 m2) renal impairment, respectively. Vaborbactam AUC ratios to subjects with normal renal function are 1.18, 2.31, and 7.8 for subjects with mild, moderate, and severe renal impairment, respectively. Vaborbactam exposure was high in subjects with end-stage renal disease and higher when administered after dialysis than when administered before.

Anti-infective considerations:

Parameters associated with efficacy:

Meropenem: See Meropenem monograph.

Vaborbactam (in combination with meropenem):

AUC, associated with free 24-hour AUC (fAUC24) of vaborbactam to meropenem-vaborbactam minimum inhibitory concentration (MIC) ratio.

Enterobacterales, including KPC-producing strains (eg, E. coli, K. pneumoniae): Vaborbactam fAUC24/meropenem-vaborbactam MIC: Goal: 18 (1-log kill), 25 (2-log kill), 36 (3-log kill), ≥24 (prevention of resistance) (Griffith 2018).

Expected drug exposure in normal renal function:

Adults: IV (3-hour infusion): Multiple doses (steady state):

Cmax (peak):

Meropenem 2 g/vaborbactam 2 g every 8 hours: Meropenem: 43.4 ± 8.8 to mg/L; vaborbactam: 55.6 ± 11 mg/L.

AUC24:

Meropenem 2 g/vaborbactam 2 g every 8 hours: Meropenem: 414 mg•hour/L; vaborbactam: 588 mg•hour/L.

Postantibiotic effect: See Meropenem monograph.

Parameters associated with toxicity: See Meropenem monograph.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Vaborem;
  • (BE) Belgium: Vaborem;
  • (CH) Switzerland: Vaborem;
  • (ES) Spain: Vaborem;
  • (FI) Finland: Vaborem;
  • (FR) France: Vaborem;
  • (GB) United Kingdom: Vaborem;
  • (IE) Ireland: Vaborem;
  • (IT) Italy: Vaborem;
  • (LT) Lithuania: Vaborem;
  • (NO) Norway: Vabomere;
  • (PR) Puerto Rico: Vabomere;
  • (SE) Sweden: Vaborem
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