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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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (0)

              Serious - Use Alternative (6)

              • 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.

              • probenecid

                probenecid increases levels of meropenem/vaborbactam by decreasing elimination. Avoid or Use Alternate Drug. Probenecid competes withe meropenem for active tubular secretion.

              • 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 (11)

              • 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.

              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.

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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 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); 75-95% (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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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Vabomere intravenous
              -
              2 gram vial

              Copyright © 2010 First DataBank, Inc.

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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.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.