meropenem/vaborbactam (Rx)

Brand and Other Names:Vabomere
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and meropenem/vaborbactam

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            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

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            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

            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

            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

            Clostridium difficile-associated diarrhea

            • Clostridium 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
            • 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
            • 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
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            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 has been 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.

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            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); 75-90% (vaborbactam)

            Excretion, feces: ~2% (meropenem)

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            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)

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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