Vabomere (meropenem/vaborbactam)
Beta-Lactams Intravenous Vial (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Meropenem and vaborbactam is a fixed combination of meropenem (a carbapenem beta-lactam antibiotic) and vaborbactam (a beta-lactamase inhibitor that prevents degradation of meropenem by certain serine beta-lactamases).
Meropenem and vaborbactam is a fixed combination of meropenem (a carbapenem) and vaborbactam (a non-beta-lactam beta-lactamase inhibitor). Vaborbactam inactivates certain bacterial beta-lactamases and expands meropenem's spectrum of activity against some bacteria that produce these beta-lactamases. Meropenem/vaborbactam is bactericidal in action.
Meropenem is a synthetic carbapenem antibiotic structurally and pharmacologically related to other carbapenems (e.g., doripenem, ertapenem, imipenem). Like other beta-lactam antibiotics, the antibacterial activity of meropenem results from inhibition of bacterial cell wall synthesis and is mediated through binding to penicillin-binding proteins (PBPs). Meropenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-negative and gram-positive bacteria, but can be hydrolyzed by carbapenemases.
Vaborbactam is a cyclic boronic acid non-beta-lactam beta-lactamase inhibitor that protects meropenem from degradation by certain beta-lactamases, primarily Ambler class A serine carbapenemases (e.g., Klebsiella pneumoniae carbapenemase (KPC)) and some class C serine carbapenemases. Vaborbactam's boronate moiety forms a covalent bond with the catalytic serine side chain of the beta-lactamase, thereby inhibiting the enzyme from degrading meropenem. This mechanism of action differs from that of beta-lactam beta-lactamase inhibitors (e.g., clavulanic acid, sulbactam, tazobactam) and some other non-beta-lactam beta-lactamase inhibitors (e.g., avibactam).
In animal models of infection, vaborbactam restored activity of meropenem against some meropenem non-susceptible KPC-producing Enterobacteriaceae. The drug does not inhibit class D carbapenemases (e.g., OXA-48) or class B beta-lactamases (e.g., metallo beta-lactamases (MBLs)). Vaborbactam does not have antibacterial activity and does not decrease the activity of meropenem against meropenem-susceptible organisms.
Each single-dose vial of meropenem/vaborbactam contains 2 g (1 g of meropenem (equivalent to 1.14 g of meropenem trihydrate) and 1 g of vaborbactam) and also contains 575 mg of sodium carbonate. The total sodium content is approximately 250 mg (10.9 mEq) per single-dose vial.
Following IV administration of 4 g of meropenem/vaborbactam (meropenem 2 g and vaborbactam 2 g) given by IV infusion over 3 hours every 8 hours for 7 days in healthy adults with normal renal function, peak plasma concentrations of the drugs were 43.4 and 55.6 mcg/mL, respectively, and there was no accumulation of either drug. Meropenem is partially metabolized by hydrolysis of the beta-lactam ring to a microbiologically inactive hydrolysis product; vaborbactam is not metabolized. The plasma protein binding of meropenem is approximately 2% and the plasma protein binding of vaborbactam is approximately 33%.
Both drugs are principally eliminated by the kidneys. Approximately 40-60% of a meropenem dose is eliminated unchanged in urine, 22% is eliminated in urine as the microbiologically inactive hydrolysis product, and approximately 2% is eliminated in feces. Approximately 75-95% of a vaborbactam dose is eliminated unchanged in urine.
In healthy adults, meropenem has a plasma half-life of 1.2 hours and vaborbactam has a plasma half-life of 1.7 hours.
USES: This product is used to treat a variety of bacterial infections. It contains 2 different medications: meropenem and vaborbactam. Meropenem is a carbapenem-type antibiotic that works by stopping the growth of bacteria.
Vaborbactam is an enzyme inhibitor (beta-lactamase inhibitor) that helps meropenem work better.
Generic name: meropenem/vaborbactam
Pronunciation: (MER-oh-PEN-em/VA-bor-BAK-tam)
Drug class: Beta-Lactams
Therapeutic class: Anti-Infective Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Vabomere
Indications
The following indications are listed for Vabomere:
- Complicated E. Coli Uti
- Enterobacter Complicated Uti
- Klebsiella Complicated Uti
Also known as: Complicated Urinary Tract Infection Due To Aerobacter, Complicated Urinary Tract Infection Due To Enterobacter, Complicated Urinary Tract Infection Due To Escherichia Coli, Complicated Urinary Tract Infection Due To Klebsiella, Complicated Uti Due To E. Coli, Complicated Uti Due To Enterobacter Species, Complicated Uti Due To Klebsiella Species.
Dosing
Meropenem/vaborbactam is a fixed combination containing a 1:1 ratio of meropenem to vaborbactam.
The meropenem component is provided as meropenem trihydrate (dosage of this component is expressed in terms of meropenem).
Dosage of the fixed combination of meropenem and vaborbactam is expressed in terms of the total of the meropenem and vaborbactam content.
Each single-dose vial of meropenem/vaborbactam contains a total of 2 g (i.e., 1 g of meropenem and 1 g of vaborbactam).
The fixed combination of meropenem and vaborbactam (meropenem/vaborbactam) is administered by IV infusion.
Meropenem/vaborbactam powder for injection must be reconstituted and further diluted prior to IV infusion.
Store unopened vials at 20-25degreesC (excursions permitted to 15-30degreesC).
| Drug label | Dosing type | Instructions |
|---|---|---|
| Vabomere 2 Gram Vial | Maintenance | Infuse 4 gram over 3 hour(s) by intravenous route every 8 hours. |
No dosing information is available for this tab.
Drug interactions
Meropenem and vaborbactam do not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4 in vitro at therapeutic concentrations. Meropenem may weakly induce CYP1A2, and meropenem and vaborbactam may weakly induce CYP3A4, and potentially other pregnane X-receptor (PXR)-regulated enzymes and transporters. Meropenem and vaborbactam are substrates of organic anion transporter (OAT)3 but not OAT1. At clinically relevant concentrations, meropenem and vaborbactam inhibit OAT3 and do not inhibit OAT1. In vitro, meropenem and vaborbactam are not substrates or inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), or organic cation transporter (OCT)2. Meropenem and vaborbactam are also not substrates of multidrug and toxin extrusion protein (MATE)1 or MATE2-K. Meropenem and vaborbactam do not inhibit OCT1, organic anion transporting polypeptide (OATP) 1B1 or 1B3, or bile salt export pump (BSEP).
Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
Antibiotics/Fecal Microbiota
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Fecal microbiota is a suspension of live bacteria, which may be compromised by concurrent use of antibiotics.(1)
CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota. Antibacterial treatment should be completed for 24 to 72 hours before initiating treatment with fecal microbiota. Do not use antibiotics for up to 8 weeks after fecal microbiota.(1)
DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota.
Antibiotics/Fecal Microbiota Spores
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1)
CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1)
DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores.
Antimicrobials/Live Typhoid Vaccine
SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.
MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1)
CLINICAL EFFECTS: Vaccination may be ineffective.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3)
DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3)
Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
Carbapenem Antibiotics/Valproic Acid
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: The exact mechanism is unknown. Carbapenems may inhibit the absorption of valproic acid from the gastrointestinal tract.(1-3) Meropenem may accelerate the renal excretion of valproate.(4) Carbapenems may increase valproic acid intake by erythrocytes.(5,6) Carbapenems may inhibit the metabolite of valproic acid, valproic acid-glucuronide, from being converted back into the active parent form.(7-9)
CLINICAL EFFECTS: Concurrent use of carbapenems and valproic acid without supplemental antiepileptic therapy is not recommended because it results in rapid, significant reductions in serum levels of valproic acid to non-therapeutic levels which may result in seizures. Dose escalation of valproic acid formulations does not counteract the decrease in serum levels and patients will require additional antiepileptic therapy. The effects may persist for several days beyond discontinuation of the carbapenem.
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Avoid the use of carbapenem antibiotics in patients maintained on valproic acid when possible. If concurrent therapy is warranted, patients will require the addition of a supplemental anti-epileptic agent until valproic acid levels return to therapeutic range.
DISCUSSION: In a retrospective review of an 18 month period, charts of 39 patients who received concurrent therapy with valproate and meropenem were examined. A pharmacokinetic interaction was observed in all 39 patients, with an average decrease in valproate levels of 66%. The decrease occurred within 24 hours of the initiation of concurrent therapy. Electroclinical deterioration was seen in 55% of patients.(10) A prospective study evaluated ICU patients given levetiracetam or valproic acid to control seizures. Twenty-four of the 35 patients required meropenem. Each patient that was on valproic acid had valproic acid levels decrease following the addition of meropenum. (13) In a study in 23 healthy male subjects, concurrent doripenem (500 mg every 8 hours) decreased the maximum concentration, (Cmax) area-under-curve (AUC), and minimum concentration (Cmin) of valproic acid by 44.5%, 63% and 77.7%, respectively.(14) There are several case reports of decreased valproic acid levels following the addition of meropenem to therapy.(4,11,12,15-21) Some patients experienced increased seizures.(4 ,11,15,16,20) In some cases, decreased levels persisted despite increased doses of valproic acid.(11,12,15,17,18,21) Others required additional anti-seizure medications during concurrent therapy.(16) Decreased valproic acid levels have also been reported during concurrent ertapenem.(22-25) Seizures were reported in two patients.(22,25) In one patient, valproic acid levels returned to therapeutic levels within three days of discontinuation of ertapenem, despite no change in valproic acid dose.(25) Decreased valproic acid levels have also been reported during concurrent imipenem.(26) A retrospective study evaluated 52 patients given valproic acid and a carbapenem over a five year period. Patients received either ertapenem, imipenem/cilastatin, or meropenem (9, 17, and 26 patients, respectively). The average serum valproic acid concentration before and after carbapenem use was 58.6 +/- 19.2 and 23.7 +/- 16.3 mg/dL, respectively, which represented a decrease of 60% +/- 23% (p<0.001). Valproic acid concentrations were reduced with both intravenous and oral formulations of valproic acid (52% +/- 16% and 61% +/-24%, respectively). Valproic acid serum concentrations were subtherapeutic (<50 mg/L) in 90% of patients during carbapenem concurrent use. Use during ertapenem, imipenem/cilastatin, and meropenem decreased valproic acid concentrations by 72% +/- 17%, 42% +/- 22%, and 67% +/- 19%, respectively.(28) A retrospective study in 54 patients treated with valproic acid for at least three months for seizure control were evaluated for changes in valproic acid with concurrent carbapenem therapy. The mean change in valproic acid levels was 80%, 68%, and 51% in the meropenem, ertapenem, and imipenem group, respectively. During concurrent therapy, 48.1% of patients experienced aggravation of seizures and 25.9% died. Valproic acid levels of those experiencing aggravation of seizures were 17.7 +/- 9.9 mcg/mL versus 17.9 +/- 12.6 mcg/mL in those without aggravation (p=0.944).(29) A retrospective study in 381 neurosurgery inpatients evaluated valproic acid levels with concurrent meropenem therapy. Patients were grouped based on valproic acid dose of 1.2 g/day or 1.6 g/day with and without meropenem. In both 1.2 g/day and 1.6 g/day valproic acid groups, valproic acid levels were decreased after initiation of meropenem (67.3 +/- 4.6 mcg/mL v. 15.3 +/- 1.9 mcg/mL; 78.2% decrease, p<0.001 for 1.2 g/day valproic acid; 67.6 +/- 1.2 mcg/mL v. 18.1 +/- 2.6 mcg/mL; 72.5% decrease, p<0.001 for 1.6 g/day valproic acid. Valproic acid concentrations recovered to levels comparable to valproic acid alone more than seven days after meropenem discontinuation.(30)
Selected Carbapenem Antibiotics/Oat1 And Oat3 Inhibitors
SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.
MECHANISM OF ACTION: Inhibitors of organic anion transporter 1 (OAT1) and organic anion transporter 3 (OAT3) may inhibit the renal excretion of doripenem(1), meropenem(2), and tebipenem(3) by competing with them for active tubular secretion.
CLINICAL EFFECTS: Concurrent use of OAT1 and OAT3 inhibitors may result in elevated levels of and toxicity from doripenem(1), meropenem(2) or tebipenem.(3)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: The US manufacturer of doripenem states that concurrent use of OAT1 and OAT3 inhibitors is not recommended.(1) The US manufacturer of meropenem states that concurrent use of OAT1 and OAT3 inhibitors is not recommended.(2) The US manufacturer of tebipenem states concurrent use of tebipenem and OAT1 and OAT3 inhibitors is generally not recommended. If concurrent use with tebipenem is necessary, monitor more frequently for adverse reactions associated with tebipenem, such as diarrhea and headache.(3)
DISCUSSION: Probenecid has been shown to increase doripenem half-life (T1/2) and area-under-curve (AUC) by 53% and 75%, respectively.(1) In a study in six subjects, concurrent probenecid increased meropenem T1/2 by 33%.(4) Other studies have shown probenecid to increase the T1/2 of meropenem by 38% and the extent of meropenem systemic exposure by 58%.(2) In a study, coadministration of a single oral dose of 250 mg of tebipenem pivoxil with probenecid (OAT1 and OAT3 inhibitor) increased tebipenem maximum concentration (Cmax) by approximately 1.5-fold and plasma area-under-curve (AUC) by approximately 2.9-fold.(3) OAT1 inhibitors linked to this monograph include: cabotegravir and probenecid. OAT3 inhibitors linked to this monograph include: cabotegravir, leflunomide, nitisinone, probenecid, teriflunomide, and vadadustat.(5)
Moderate Interaction: Assess the risk to the patient and take action as needed.
Meropenem-Vaborbactam/Hormonal Contraceptives
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Meropenem-vaborbactam may induce the CYP3A4-mediated metabolism of hormonal contraceptives.(1,2)
CLINICAL EFFECTS: Concurrent use of meropenem-vaborbactam may reduce the blood concentrations and effectiveness of hormonal contraceptives.(1,2)
PREDISPOSING FACTORS: None determined.
PATIENT MANAGEMENT: Women of reproductive age should be counseled not to rely on hormonal contraception (including oral contraceptives, patches, implants, and/or IUDs) for contraception. Women should use an effective non-hormonal method of contraception or an additional method of birth control during and for 28 days after meropenem-vaborbactam therapy.(1,2) For emergency contraception, the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) recommends that women who have used a CYP3A4 inducer in the previous 4 weeks should consider a non-hormonal emergency contraceptive (i.e., a copper IUD). If a non-hormonal emergency contraceptive is not an option, double the usual dose of levonorgestrel from 1.5 to 3 mg. Advise the patient to have a pregnancy test to exclude pregnancy after use and to seek medical advice if they do become pregnant.(2)
DISCUSSION: There have been no studies evaluating the potential of meropenem-vaborbactam to interact with other drugs. In vitro data suggest that both meropenem and vaborbactam are weak CYP3A4 inducers.(1,2)
Moderate And Weak Cyp3a4 Inducers/Tacrolimus
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Moderate or weak CYP3A4 inducers may accelerate the metabolism of tacrolimus.(1)
CLINICAL EFFECTS: Concurrent use of a moderate or weak CYP3A4 inducer may result in decreased levels and effectiveness of tacrolimus.(1)
PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks.
PATIENT MANAGEMENT: The manufacturer of tacrolimus recommends monitoring tacrolimus whole blood trough concentrations and adjusting tacrolimus dose if needed. Monitor clinical response closely.(1)
DISCUSSION: A 13-year-old cystic fibrosis patient with a history of liver transplant on stable doses of tacrolimus underwent 2 separate courses of nafcillin therapy (a moderate CYP3A4 inducer). During the 1st course of nafcillin, his tacrolimus levels started to fall 3 days after starting nafcillin, became undetectable at day 8, and recovered to therapeutic levels without a change in tacrolimus dose 5 days after discontinuation of nafcillin. During the 2nd course of nafcillin, tacrolimus level became undetectable 4 days after starting nafcillin and recovered 3 days after stopping nafcillin.(2) Moderate inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 50-80% and include: belzutifan, bosentan, cenobamate, dabrafenib, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, modafinil, nafcillin, repotrectinib, telotristat, and tovorafenib.(3,4) Weak inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 20-50% and include: armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, darolutamide, dexamethasone, dicloxacillin, echinacea, elafibranor, enasidenib, eslicarbazepine, floxacillin, garlic, genistein, ginseng, glycyrrhizin, meropenem-vaborbactam, nevirapine, oritavancin, omaveloxolone, oxcarbazepine, pioglitazone, relugolix, rufinamide, sulfinpyrazone, sunvozertinib, suzetrigine, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vinblastine, and zanubrutinib.(3,4)
Moderate And Weak Cyp3a4 Inducers/Ubrogepant
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: Moderate or weak CYP3A4 inducers may induce the metabolism of ubrogepant.(1)
CLINICAL EFFECTS: Concurrent use of a moderate or weak CYP3A4 inducer may result in decreased levels and effectiveness of ubrogepant.(1)
PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks.
PATIENT MANAGEMENT: The manufacturer recommends a dosage adjustment of ubrogepant when coadministered with moderate or weak CYP3A4 inducers. Initial dose of ubrogepant should be 100 mg. If a second dose is needed, the dose of ubrogepant should be 100 mg.(1)
DISCUSSION: Coadministration of ubrogepant with rifampin, a strong CYP3A4 inducer, resulted in an 80% reduction in ubrogepant exposure. No dedicated drug interaction studies were conducted to assess concomitant use with moderate or weak CYP3A4 inducers. Dose adjustment for concomitant use of ubrogepant with moderate or weak CYP3A4 inducers is recommended based on a conservative prediction of 50% reduction in exposure of ubrogepant.(1) Moderate inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 50-80% and include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, etravirine, fexinidazole, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pexidartinib, rifabutin, telotristat, thioridazine, and tovorafenib.(2,3) Weak inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 20-50% and include: armodafinil, bexarotene, brigatinib, brivaracetam, clobazam, danshen, dexamethasone, dicloxacillin, echinacea, elafibranor, eslicarbazepine, floxacillin, garlic, genistein, ginseng, glycyrrhizin, meropenem-vaborbactam, methylprednisolone, nevirapine, omaveloxolone, oritavancin, oxcarbazepine, pioglitazone, pitolisant, relugolix, repotrectinib, rufinamide, sarilumab, sulfinpyrazone, sunvozertinib, suzetrigine, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vemurafenib, vinblastine, and zanubrutinib.(2,3)
Selected Moderate-Weak Cyp3a4 Inducers/Exemestane
SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.
MECHANISM OF ACTION: CYP3A4 inducers may induce the metabolism of exemestane.(1)
CLINICAL EFFECTS: Concurrent use of a CYP3A4 inducer may result in decreased levels and effectiveness of exemestane.(1)
PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks.
PATIENT MANAGEMENT: The US manufacturer of exemestane recommends that patients receiving concurrent therapy with a strong CYP3A4 inducer receive 50 mg of exemestane daily after a meal.(1) It may be prudent to consider a dosage increase for patients receiving weaker CYP3A4 inducers.
DISCUSSION: In a study in 10 healthy postmenopausal subjects, pretreatment with rifampin (a strong CYP3A4 inducer, 600 mg daily for 14 days) decreased the area-under-curve (AUC) and maximum concentration (Cmax) of a single dose of exemestane (25 mg) by 54% and 41%, respectively.(1) Strong inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 80% or more and include: carbamazepine, enzalutamide, mitotane, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort.(1-3) Moderate inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 50-80% and include: belzutifan, bosentan, cenobamate, dabrafenib, dipyrone, efavirenz, elagolix, etravirine, fexinidazole, lesinurad, mavacamten, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, repotrectinib, rifabutin, sotorasib, telotristat ethyl, thioridazine, and tovorafenib.(2,3) Weak inducers of CYP3A4 would be expected to decrease the AUC of a sensitive 3A4 substrate by 20-50% and include: armodafinil, aumolertinib, bexarotene, brigatinib, brivaracetam, clobazam, danshen, darolutamide, dexamethasone, dicloxacillin, echinacea, elafibranor, enasidenib, eslicarbazepine, floxacillin, garlic, gingko, ginseng, glycyrrhizin, lorlatinib, meropenem-vaborbactam, methylprednisolone, nevirapine, omaveloxolone, oritavancin, oxcarbazepine, pioglitazone, pitolisant, quercetin, relugolix, rufinamide, sarilumab, sulfinpyrazone, sunvozertinib, suzetrigine, tazemetostat, tecovirimat, terbinafine, ticlopidine, topiramate, troglitazone, vemurafenib, vinblastine, and zanubrutinib.(2,3)
Contraindications
*Hypersensitivity to any component of meropenem/vaborbactam or other drugs in the same class.
*History of anaphylactic reactions to beta-lactam antibacterials.
There are no contraindication contraindications for this drug.
- Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
- Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Clostridioides difficile infection
- Kidney disease with likely reduction in glomerular filtration rate (GFr)
- Cerebral lesions
- Lower seizure threshold
- Seizure disorder
- Thrombocytopenic disorder
Adverse reactions
The most commonly reported adverse reactions (>=3%) of patients treated with meropenem/vaborbactam include headache, phlebitis/infusion site reactions, and diarrhea.
More Frequent
- Injection site sequelae
Less Frequent
- Abnormal hepatic function tests
- Hypersensitivity drug reaction
- Hypokalemia
Rare or Very Rare
- Agranulocytosis
- Anaphylaxis
- Angioedema
- Azotemia
- Clostridioides difficile infection
- Deep venous thrombosis
- DRESS syndrome
- Drug-induced hepatitis
- Eosinophilia
- Hemolytic anemia
- Hepatic failure
- Hyperbilirubinemia
- Hyperkalemia
- Hypoglycemic disorder
- Hypotension
- Increased alanine transaminase
- Increased aspartate transaminase
- Jaundice
- Kidney disease with reduction in glomerular filtration rate (GFr)
- Leukopenia
- Neutropenic disorder
- Rhabdomyolysis
- Seizure disorder
- Thrombocytopenic disorder
- Thrombocytosis
- Thrombophlebitis
- Urticaria
More Frequent
- Diarrhea
- Headache disorder
- Phlebitis after infusion
Less Frequent
- Nausea
- Oral candidiasis
Rare or Very Rare
- Acute abdominal pain
- Anorexia
- Chest discomfort
- Delirium
- Dizziness
- Fever
- Hallucinations
- Hyperglycemia
- Insomnia
- Lethargy
- Pain
- Paresthesia
- Pharyngitis
- Pruritus of skin
- Skin rash
- Tremor
- Vulvovaginal candidiasis
Precautions
No enhanced messaging available.
Safety and efficacy of meropenem/vaborbactam have not been established in pediatric patients younger than 18 years of age.
Fetal malformations (e.g., supernumerary lung lobes, interventricular septal defect) were observed in rabbits receiving IV vaborbactam during organogenesis at doses approximately equivalent to or greater than the maximum recommended human dose. Similar malformations or fetal toxicity were not observed in offspring from pregnant rats receiving IV vaborbactam during organogenesis or from late pregnancy and through lactation at doses equivalent to approximately 1.6 times the maximum recommended human dose. No fetal toxicity or malformations were observed in pregnant rats or cynomolgus monkeys receiving IV meropenem during organogenesis at doses up to 1.6 or 1.2 times the maximum recommended human dose, respectively.
Human data are insufficient to determine whether there is a drug-associated risk of major birth defects or miscarriages if the fixed combination of meropenem and vaborbactam, meropenem alone, or vaborbactam alone is used in pregnant women.
Meropenem has been reported to be distributed into human milk. It is not known whether vaborbactam is distributed into human milk.
The benefits of breast-feeding and the importance of meropenem and vaborbactam to the woman should be considered along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.
Dosage adjustments are not needed when meropenem/vaborbactam is used in geriatric patients. However, because geriatric patients are more likely to have decreased renal function and dosage of meropenem/vaborbactam needs to be adjusted based on renal impairment, select dosage with caution and monitor renal function.
No overall differences in safety and efficacy of meropenem/vaborbactam were observed in patients 65 years of age and older compared with younger adults, but greater sensitivity in some older individuals cannot be ruled out.
Meropenem is substantially eliminated by the kidneys, and the risk of adverse reactions to the drug may be greater in patients with renal impairment. Because geriatric patients are more likely to have decreased renal function, dosage should be selected with caution and renal function monitoring should be considered. Dosage adjustments in geriatric patients should be based on renal function.
Population pharmacokinetic analysis indicates that the pharmacokinetics of meropenem/vaborbactam in geriatric patients is similar to that in younger adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| Complicated e. coli UTI | ||
| B96.2 | ICD10CM | Escherichia coli [e. coli ] as the cause of diseases classified elsewhere |
| B96.20 | ICD10CM | Unspecified escherichia coli [e. coli] as the cause of diseases classified elsewhere |
| B96.29 | ICD10CM | Other escherichia coli [e. coli] as the cause of diseases classified elsewhere |
| N39.0 | ICD10CM | Urinary tract infection, site not specified |
| O23.0 | ICD10CM | Infections of kidney in pregnancy |
| O23.00 | ICD10CM | Infections of kidney in pregnancy, unspecified trimester |
| O23.01 | ICD10CM | Infections of kidney in pregnancy, first trimester |
| O23.02 | ICD10CM | Infections of kidney in pregnancy, second trimester |
| O23.03 | ICD10CM | Infections of kidney in pregnancy, third trimester |
| O23.1 | ICD10CM | Infections of bladder in pregnancy |
| O23.10 | ICD10CM | Infections of bladder in pregnancy, unspecified trimester |
| O23.11 | ICD10CM | Infections of bladder in pregnancy, first trimester |
| O23.12 | ICD10CM | Infections of bladder in pregnancy, second trimester |
| O23.13 | ICD10CM | Infections of bladder in pregnancy, third trimester |
| O23.2 | ICD10CM | Infections of urethra in pregnancy |
| O23.20 | ICD10CM | Infections of urethra in pregnancy, unspecified trimester |
| O23.21 | ICD10CM | Infections of urethra in pregnancy, first trimester |
| O23.22 | ICD10CM | Infections of urethra in pregnancy, second trimester |
| O23.23 | ICD10CM | Infections of urethra in pregnancy, third trimester |
| O23.3 | ICD10CM | Infections of other parts of urinary tract in pregnancy |
| O23.30 | ICD10CM | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
| O23.31 | ICD10CM | Infections of other parts of urinary tract in pregnancy, first trimester |
| O23.32 | ICD10CM | Infections of other parts of urinary tract in pregnancy, second trimester |
| O23.33 | ICD10CM | Infections of other parts of urinary tract in pregnancy, third trimester |
| O23.4 | ICD10CM | Unspecified infection of urinary tract in pregnancy |
| O23.40 | ICD10CM | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
| O23.41 | ICD10CM | Unspecified infection of urinary tract in pregnancy, first trimester |
| O23.42 | ICD10CM | Unspecified infection of urinary tract in pregnancy, second trimester |
| O23.43 | ICD10CM | Unspecified infection of urinary tract in pregnancy, third trimester |
| T83.5 | ICD10CM | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.51 | ICD10CM | Infection and inflammatory reaction due to urinary catheter |
| T83.510 | ICD10CM | Infection and inflammatory reaction due to cystostomy catheter |
| T83.510A | ICD10CM | Infection and inflammatory reaction due to cystostomy catheter, initial encounter |
| T83.511 | ICD10CM | Infection and inflammatory reaction due to indwelling urethral catheter |
| T83.511A | ICD10CM | Infection and inflammatory reaction due to indwelling urethral catheter, initial encounter |
| T83.512 | ICD10CM | Infection and inflammatory reaction due to nephrostomy catheter |
| T83.512A | ICD10CM | Infection and inflammatory reaction due to nephrostomy catheter, initial encounter |
| T83.518 | ICD10CM | Infection and inflammatory reaction due to other urinary catheter |
| T83.518A | ICD10CM | Infection and inflammatory reaction due to other urinary catheter, initial encounter |
| T83.59 | ICD10CM | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.590 | ICD10CM | Infection and inflammatory reaction due to implanted urinary neurostimulation device |
| T83.590A | ICD10CM | Infection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter |
| T83.591 | ICD10CM | Infection and inflammatory reaction due to implanted urinary sphincter |
| T83.591A | ICD10CM | Infection and inflammatory reaction due to implanted urinary sphincter, initial encounter |
| T83.592 | ICD10CM | Infection and inflammatory reaction due to indwelling ureteral stent |
| T83.592A | ICD10CM | Infection and inflammatory reaction due to indwelling ureteral stent, initial encounter |
| T83.593 | ICD10CM | Infection and inflammatory reaction due to other urinary stents |
| T83.593A | ICD10CM | Infection and inflammatory reaction due to other urinary stents, initial encounter |
| T83.598 | ICD10CM | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system |
| T83.598A | ICD10CM | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter |
| Enterobacter complicated UTI | ||
| B96.89 | ICD10CM | Other specified bacterial agents as the cause of diseases classified elsewhere |
| N39.0 | ICD10CM | Urinary tract infection, site not specified |
| O23.0 | ICD10CM | Infections of kidney in pregnancy |
| O23.00 | ICD10CM | Infections of kidney in pregnancy, unspecified trimester |
| O23.01 | ICD10CM | Infections of kidney in pregnancy, first trimester |
| O23.02 | ICD10CM | Infections of kidney in pregnancy, second trimester |
| O23.03 | ICD10CM | Infections of kidney in pregnancy, third trimester |
| O23.1 | ICD10CM | Infections of bladder in pregnancy |
| O23.10 | ICD10CM | Infections of bladder in pregnancy, unspecified trimester |
| O23.11 | ICD10CM | Infections of bladder in pregnancy, first trimester |
| O23.12 | ICD10CM | Infections of bladder in pregnancy, second trimester |
| O23.13 | ICD10CM | Infections of bladder in pregnancy, third trimester |
| O23.2 | ICD10CM | Infections of urethra in pregnancy |
| O23.20 | ICD10CM | Infections of urethra in pregnancy, unspecified trimester |
| O23.21 | ICD10CM | Infections of urethra in pregnancy, first trimester |
| O23.22 | ICD10CM | Infections of urethra in pregnancy, second trimester |
| O23.23 | ICD10CM | Infections of urethra in pregnancy, third trimester |
| O23.3 | ICD10CM | Infections of other parts of urinary tract in pregnancy |
| O23.30 | ICD10CM | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
| O23.31 | ICD10CM | Infections of other parts of urinary tract in pregnancy, first trimester |
| O23.32 | ICD10CM | Infections of other parts of urinary tract in pregnancy, second trimester |
| O23.33 | ICD10CM | Infections of other parts of urinary tract in pregnancy, third trimester |
| O23.4 | ICD10CM | Unspecified infection of urinary tract in pregnancy |
| O23.40 | ICD10CM | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
| O23.41 | ICD10CM | Unspecified infection of urinary tract in pregnancy, first trimester |
| O23.42 | ICD10CM | Unspecified infection of urinary tract in pregnancy, second trimester |
| O23.43 | ICD10CM | Unspecified infection of urinary tract in pregnancy, third trimester |
| T83.5 | ICD10CM | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.51 | ICD10CM | Infection and inflammatory reaction due to urinary catheter |
| T83.510 | ICD10CM | Infection and inflammatory reaction due to cystostomy catheter |
| T83.510A | ICD10CM | Infection and inflammatory reaction due to cystostomy catheter, initial encounter |
| T83.511 | ICD10CM | Infection and inflammatory reaction due to indwelling urethral catheter |
| T83.511A | ICD10CM | Infection and inflammatory reaction due to indwelling urethral catheter, initial encounter |
| T83.512 | ICD10CM | Infection and inflammatory reaction due to nephrostomy catheter |
| T83.512A | ICD10CM | Infection and inflammatory reaction due to nephrostomy catheter, initial encounter |
| T83.518 | ICD10CM | Infection and inflammatory reaction due to other urinary catheter |
| T83.518A | ICD10CM | Infection and inflammatory reaction due to other urinary catheter, initial encounter |
| T83.59 | ICD10CM | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.590 | ICD10CM | Infection and inflammatory reaction due to implanted urinary neurostimulation device |
| T83.590A | ICD10CM | Infection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter |
| T83.591 | ICD10CM | Infection and inflammatory reaction due to implanted urinary sphincter |
| T83.591A | ICD10CM | Infection and inflammatory reaction due to implanted urinary sphincter, initial encounter |
| T83.592 | ICD10CM | Infection and inflammatory reaction due to indwelling ureteral stent |
| T83.592A | ICD10CM | Infection and inflammatory reaction due to indwelling ureteral stent, initial encounter |
| T83.593 | ICD10CM | Infection and inflammatory reaction due to other urinary stents |
| T83.593A | ICD10CM | Infection and inflammatory reaction due to other urinary stents, initial encounter |
| T83.598 | ICD10CM | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system |
| T83.598A | ICD10CM | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter |
| Klebsiella complicated UTI | ||
| B96.1 | ICD10CM | Klebsiella pneumoniae [k. pneumoniae] as the cause of diseases classified elsewhere |
| N39.0 | ICD10CM | Urinary tract infection, site not specified |
| O23.0 | ICD10CM | Infections of kidney in pregnancy |
| O23.00 | ICD10CM | Infections of kidney in pregnancy, unspecified trimester |
| O23.01 | ICD10CM | Infections of kidney in pregnancy, first trimester |
| O23.02 | ICD10CM | Infections of kidney in pregnancy, second trimester |
| O23.03 | ICD10CM | Infections of kidney in pregnancy, third trimester |
| O23.1 | ICD10CM | Infections of bladder in pregnancy |
| O23.10 | ICD10CM | Infections of bladder in pregnancy, unspecified trimester |
| O23.11 | ICD10CM | Infections of bladder in pregnancy, first trimester |
| O23.12 | ICD10CM | Infections of bladder in pregnancy, second trimester |
| O23.13 | ICD10CM | Infections of bladder in pregnancy, third trimester |
| O23.2 | ICD10CM | Infections of urethra in pregnancy |
| O23.20 | ICD10CM | Infections of urethra in pregnancy, unspecified trimester |
| O23.21 | ICD10CM | Infections of urethra in pregnancy, first trimester |
| O23.22 | ICD10CM | Infections of urethra in pregnancy, second trimester |
| O23.23 | ICD10CM | Infections of urethra in pregnancy, third trimester |
| O23.3 | ICD10CM | Infections of other parts of urinary tract in pregnancy |
| O23.30 | ICD10CM | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
| O23.31 | ICD10CM | Infections of other parts of urinary tract in pregnancy, first trimester |
| O23.32 | ICD10CM | Infections of other parts of urinary tract in pregnancy, second trimester |
| O23.33 | ICD10CM | Infections of other parts of urinary tract in pregnancy, third trimester |
| O23.4 | ICD10CM | Unspecified infection of urinary tract in pregnancy |
| O23.40 | ICD10CM | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
| O23.41 | ICD10CM | Unspecified infection of urinary tract in pregnancy, first trimester |
| O23.42 | ICD10CM | Unspecified infection of urinary tract in pregnancy, second trimester |
| O23.43 | ICD10CM | Unspecified infection of urinary tract in pregnancy, third trimester |
| T83.5 | ICD10CM | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.51 | ICD10CM | Infection and inflammatory reaction due to urinary catheter |
| T83.510 | ICD10CM | Infection and inflammatory reaction due to cystostomy catheter |
| T83.510A | ICD10CM | Infection and inflammatory reaction due to cystostomy catheter, initial encounter |
| T83.511 | ICD10CM | Infection and inflammatory reaction due to indwelling urethral catheter |
| T83.511A | ICD10CM | Infection and inflammatory reaction due to indwelling urethral catheter, initial encounter |
| T83.512 | ICD10CM | Infection and inflammatory reaction due to nephrostomy catheter |
| T83.512A | ICD10CM | Infection and inflammatory reaction due to nephrostomy catheter, initial encounter |
| T83.518 | ICD10CM | Infection and inflammatory reaction due to other urinary catheter |
| T83.518A | ICD10CM | Infection and inflammatory reaction due to other urinary catheter, initial encounter |
| T83.59 | ICD10CM | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.590 | ICD10CM | Infection and inflammatory reaction due to implanted urinary neurostimulation device |
| T83.590A | ICD10CM | Infection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter |
| T83.591 | ICD10CM | Infection and inflammatory reaction due to implanted urinary sphincter |
| T83.591A | ICD10CM | Infection and inflammatory reaction due to implanted urinary sphincter, initial encounter |
| T83.592 | ICD10CM | Infection and inflammatory reaction due to indwelling ureteral stent |
| T83.592A | ICD10CM | Infection and inflammatory reaction due to indwelling ureteral stent, initial encounter |
| T83.593 | ICD10CM | Infection and inflammatory reaction due to other urinary stents |
| T83.593A | ICD10CM | Infection and inflammatory reaction due to other urinary stents, initial encounter |
| T83.598 | ICD10CM | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system |
| T83.598A | ICD10CM | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter |
ICD code information from First Databank (FDB).
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Last reviewed · Source: First Databank (FDB) drug data
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