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Drug overview for VABOMERE (meropenem/vaborbactam):
Generic name: meropenem/vaborbactam (MER-oh-PEN-em/VA-bor-BAK-tam)
Drug class: Beta-Lactams
Therapeutic class: Anti-Infective Agents
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).
No enhanced Uses information available for this drug.
Generic name: meropenem/vaborbactam (MER-oh-PEN-em/VA-bor-BAK-tam)
Drug class: Beta-Lactams
Therapeutic class: Anti-Infective Agents
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).
No enhanced Uses information available for this drug.
DRUG IMAGES
VABOMERE 2 GRAM VIAL
The following indications for VABOMERE (meropenem/vaborbactam) have been approved by the FDA:
Indications:
Complicated E. coli UTI
Enterobacter complicated UTI
Klebsiella complicated UTI
Professional Synonyms:
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
Indications:
Complicated E. coli UTI
Enterobacter complicated UTI
Klebsiella complicated UTI
Professional Synonyms:
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
The following dosing information is available for VABOMERE (meropenem/vaborbactam):
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 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 | DOSING INSTRUCTIONS |
|---|---|---|
| VABOMERE 2 GRAM VIAL | Maintenance | Adults infuse 4 gram over 3 hour(s) by intravenous route every 8 hours |
No generic dosing information available.
The following drug interaction information is available for VABOMERE (meropenem/vaborbactam):
There are 3 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Live Typhoid Vaccine/Antimicrobials 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) |
VIVOTIF |
| Fecal Microbiota Spores/Antibiotics 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. |
VOWST |
| Fecal Microbiota/Antibiotics 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. |
REBYOTA |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Valproic Acid/Carbapenem Antibiotics 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) |
DEPAKOTE, DEPAKOTE ER, DEPAKOTE SPRINKLE, DIVALPROEX SODIUM, DIVALPROEX SODIUM ER, SODIUM VALPROATE, VALPROATE SODIUM, VALPROIC ACID |
| Doripenem; Meropenem/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 3 (OAT3) may inhibit the renal excretion of doripenem (1) and meropenem(2) by competing with them for active tubular secretion. CLINICAL EFFECTS: Concurrent use of organic anion transporter 3 (OAT3) inhibitors may result in elevated levels of and toxicity from doripenem(1) or meropenem.(2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of doripenem states that concurrent use of organic anion transporter 3 (OAT3) inhibitors is not recommended.(1) The US manufacturer of meropenem states that concurrent use of OAT3 inhibitors is not recommended.(2) 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%.(3) Other studies have shown probenecid to increase the T1/2 of meropenem by 38% and the extent of meropenem systemic exposure by 58%.(2) OAT3 inhibitors linked to this monograph include: cabotegravir, leflunomide, nitisinone, probenecid, teriflunomide, and vadadustat.(4) |
APRETUDE, ARAVA, AUBAGIO, CABENUVA, CABOTEGRAVIR ER (CABENUVA), HARLIKU, LEFLUNICLO, LEFLUNOMIDE, NITISINONE, NITYR, ORFADIN, ORLYNVAH, PROBENECID, PROBENECID-COLCHICINE, TERIFLUNOMIDE, VAFSEO, VOCABRIA |
There are 4 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Exemestane/Selected Moderate-Weak CYP3A4 Inducers 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, 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, 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) |
AROMASIN, EXEMESTANE |
| Ubrogepant/Moderate and Weak CYP3A4 Inducers 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, 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) |
UBRELVY |
| Tacrolimus/Moderate and Weak CYP3A4 Inducers 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) |
ASTAGRAF XL, ENVARSUS XR, PROGRAF, TACROLIMUS, TACROLIMUS XL |
| Hormonal Contraceptives/Meropenem-Vaborbactam 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) |
2-METHOXYESTRADIOL, AFIRMELLE, ALTAVERA, ALYACEN, AMETHIA, AMETHYST, ANNOVERA, APRI, ARANELLE, ASHLYNA, AUBRA, AUBRA EQ, AUROVELA, AUROVELA 24 FE, AUROVELA FE, AVERI, AVIANE, AYUNA, AZURETTE, BALCOLTRA, BALZIVA, BEYAZ, BLISOVI 24 FE, BLISOVI FE, BRIELLYN, CAMILA, CAMRESE, CAMRESE LO, CAZIANT, CHARLOTTE 24 FE, CHATEAL EQ, CRYSELLE, CYRED, CYRED EQ, DASETTA, DAYSEE, DEBLITANE, DEPO-PROVERA, DEPO-SUBQ PROVERA 104, DESOGESTR-ETH ESTRAD ETH ESTRA, DIETHYLSTILBESTROL, DOLISHALE, DROSPIRENONE-ETH ESTRA-LEVOMEF, DROSPIRENONE-ETHINYL ESTRADIOL, ELINEST, ELLA, ELURYNG, EMZAHH, ENILLORING, ENPRESSE, ENSKYCE, ERRIN, ESTARYLLA, ESTRADIOL, ESTRADIOL BENZOATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL HEMIHYDRATE MICRO, ESTRADIOL MICRONIZED, ESTRADIOL VALERATE, ESTRIOL, ESTRIOL MICRONIZED, ESTRONE, ETHINYL ESTRADIOL, ETONOGESTREL-ETHINYL ESTRADIOL, FALMINA, FEIRZA, FEMLYV, FINZALA, GALBRIELA, GEMMILY, HAILEY, HAILEY 24 FE, HAILEY FE, HALOETTE, HEATHER, ICLEVIA, INCASSIA, INTROVALE, ISIBLOOM, JAIMIESS, JASMIEL, JENCYCLA, JOLESSA, JOYEAUX, JULEBER, JUNEL, JUNEL FE, JUNEL FE 24, KAITLIB FE, KALLIGA, KARIVA, KELNOR 1-35, KURVELO, LARIN, LARIN 24 FE, LARIN FE, LESSINA, LEVONEST, LEVONORG-ETH ESTRAD ETH ESTRAD, LEVONORG-ETH ESTRAD-FE BISGLYC, LEVONORGESTREL-ETH ESTRADIOL, LO LOESTRIN FE, LO-ZUMANDIMINE, LOESTRIN, LOESTRIN FE, LOJAIMIESS, LORYNA, LOW-OGESTREL, LUIZZA, LUTERA, LYLEQ, LYZA, MARLISSA, MEDROXYPROGESTERONE ACETATE, MELEYA, MIBELAS 24 FE, MICROGESTIN, MICROGESTIN FE, MILI, MINZOYA, MONO-LINYAH, NATAZIA, NECON, NEXPLANON, NEXTSTELLIS, NIKKI, NORA-BE, NORELGESTROMIN-ETH ESTRADIOL, NORETHINDRON-ETHINYL ESTRADIOL, NORETHINDRONE, NORETHINDRONE-E.ESTRADIOL-IRON, NORGESTIMATE-ETHINYL ESTRADIOL, NORTREL, NUVARING, NYLIA, OCELLA, ORQUIDEA, ORTHO TRI-CYCLEN, ORTHO-NOVUM, PHILITH, PIMTREA, PORTIA, RECLIPSEN, RIVELSA, ROSYRAH, SAFYRAL, SETLAKIN, SHAROBEL, SIMLIYA, SIMPESSE, SLYND, SPRINTEC, SYEDA, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-ESTARYLLA, TRI-LEGEST FE, TRI-LINYAH, TRI-LO-ESTARYLLA, TRI-LO-MARZIA, TRI-LO-MILI, TRI-LO-SPRINTEC, TRI-MILI, TRI-SPRINTEC, TRI-VYLIBRA, TRI-VYLIBRA LO, TULANA, TURQOZ, TWIRLA, TYBLUME, TYDEMY, VALTYA, VELIVET, VESTURA, VIENVA, VIORELE, VOLNEA, VYFEMLA, VYLIBRA, WERA, WYMZYA FE, XARAH FE, XELRIA FE, XULANE, YASMIN 28, YAZ, ZAFEMY, ZARAH, ZOVIA 1-35, ZUMANDIMINE |
The following contraindication information is available for VABOMERE (meropenem/vaborbactam):
Drug contraindication overview.
*Hypersensitivity to any component of meropenem/vaborbactam or other drugs in the same class. *History of anaphylactic reactions to beta-lactam antibacterials.
*Hypersensitivity to any component of meropenem/vaborbactam or other drugs in the same class. *History of anaphylactic reactions to beta-lactam antibacterials.
There are 0 contraindications.
There are 6 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| 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) |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Cerebral lesions |
| Lower seizure threshold |
| Seizure disorder |
| Thrombocytopenic disorder |
The following adverse reaction information is available for VABOMERE (meropenem/vaborbactam):
Adverse reaction overview.
The most commonly reported adverse reactions (>=3%) of patients treated with meropenem/vaborbactam include headache, phlebitis/infusion site reactions, and diarrhea.
The most commonly reported adverse reactions (>=3%) of patients treated with meropenem/vaborbactam include headache, phlebitis/infusion site reactions, and diarrhea.
There are 31 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Injection site sequelae |
Abnormal hepatic function tests Hypersensitivity drug reaction Hypokalemia |
| Rare/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 |
There are 22 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Headache disorder Phlebitis after infusion |
Nausea Oral candidiasis |
| Rare/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 |
The following precautions are available for VABOMERE (meropenem/vaborbactam):
Safety and efficacy of meropenem/vaborbactam have not been established in pediatric patients younger than 18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
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.
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.
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.
The following prioritized warning is available for VABOMERE (meropenem/vaborbactam):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for VABOMERE (meropenem/vaborbactam)'s list of indications:
| Complicated e. coli UTI | |
| B96.2 | Escherichia coli [e. coli ] as the cause of diseases classified elsewhere |
| B96.20 | Unspecified escherichia coli [e. coli] as the cause of diseases classified elsewhere |
| B96.29 | Other escherichia coli [e. coli] as the cause of diseases classified elsewhere |
| N39.0 | Urinary tract infection, site not specified |
| O23.0 | Infections of kidney in pregnancy |
| O23.00 | Infections of kidney in pregnancy, unspecified trimester |
| O23.01 | Infections of kidney in pregnancy, first trimester |
| O23.02 | Infections of kidney in pregnancy, second trimester |
| O23.03 | Infections of kidney in pregnancy, third trimester |
| O23.1 | Infections of bladder in pregnancy |
| O23.10 | Infections of bladder in pregnancy, unspecified trimester |
| O23.11 | Infections of bladder in pregnancy, first trimester |
| O23.12 | Infections of bladder in pregnancy, second trimester |
| O23.13 | Infections of bladder in pregnancy, third trimester |
| O23.2 | Infections of urethra in pregnancy |
| O23.20 | Infections of urethra in pregnancy, unspecified trimester |
| O23.21 | Infections of urethra in pregnancy, first trimester |
| O23.22 | Infections of urethra in pregnancy, second trimester |
| O23.23 | Infections of urethra in pregnancy, third trimester |
| O23.3 | Infections of other parts of urinary tract in pregnancy |
| O23.30 | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
| O23.31 | Infections of other parts of urinary tract in pregnancy, first trimester |
| O23.32 | Infections of other parts of urinary tract in pregnancy, second trimester |
| O23.33 | Infections of other parts of urinary tract in pregnancy, third trimester |
| O23.4 | Unspecified infection of urinary tract in pregnancy |
| O23.40 | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
| O23.41 | Unspecified infection of urinary tract in pregnancy, first trimester |
| O23.42 | Unspecified infection of urinary tract in pregnancy, second trimester |
| O23.43 | Unspecified infection of urinary tract in pregnancy, third trimester |
| T83.5 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.51 | Infection and inflammatory reaction due to urinary catheter |
| T83.510 | Infection and inflammatory reaction due to cystostomy catheter |
| T83.510A | Infection and inflammatory reaction due to cystostomy catheter, initial encounter |
| T83.511 | Infection and inflammatory reaction due to indwelling urethral catheter |
| T83.511A | Infection and inflammatory reaction due to indwelling urethral catheter, initial encounter |
| T83.512 | Infection and inflammatory reaction due to nephrostomy catheter |
| T83.512A | Infection and inflammatory reaction due to nephrostomy catheter, initial encounter |
| T83.518 | Infection and inflammatory reaction due to other urinary catheter |
| T83.518A | Infection and inflammatory reaction due to other urinary catheter, initial encounter |
| T83.59 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.590 | Infection and inflammatory reaction due to implanted urinary neurostimulation device |
| T83.590A | Infection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter |
| T83.591 | Infection and inflammatory reaction due to implanted urinary sphincter |
| T83.591A | Infection and inflammatory reaction due to implanted urinary sphincter, initial encounter |
| T83.592 | Infection and inflammatory reaction due to indwelling ureteral stent |
| T83.592A | Infection and inflammatory reaction due to indwelling ureteral stent, initial encounter |
| T83.593 | Infection and inflammatory reaction due to other urinary stents |
| T83.593A | Infection and inflammatory reaction due to other urinary stents, initial encounter |
| T83.598 | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system |
| T83.598A | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter |
| Enterobacter complicated UTI | |
| B96.89 | Other specified bacterial agents as the cause of diseases classified elsewhere |
| N39.0 | Urinary tract infection, site not specified |
| O23.0 | Infections of kidney in pregnancy |
| O23.00 | Infections of kidney in pregnancy, unspecified trimester |
| O23.01 | Infections of kidney in pregnancy, first trimester |
| O23.02 | Infections of kidney in pregnancy, second trimester |
| O23.03 | Infections of kidney in pregnancy, third trimester |
| O23.1 | Infections of bladder in pregnancy |
| O23.10 | Infections of bladder in pregnancy, unspecified trimester |
| O23.11 | Infections of bladder in pregnancy, first trimester |
| O23.12 | Infections of bladder in pregnancy, second trimester |
| O23.13 | Infections of bladder in pregnancy, third trimester |
| O23.2 | Infections of urethra in pregnancy |
| O23.20 | Infections of urethra in pregnancy, unspecified trimester |
| O23.21 | Infections of urethra in pregnancy, first trimester |
| O23.22 | Infections of urethra in pregnancy, second trimester |
| O23.23 | Infections of urethra in pregnancy, third trimester |
| O23.3 | Infections of other parts of urinary tract in pregnancy |
| O23.30 | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
| O23.31 | Infections of other parts of urinary tract in pregnancy, first trimester |
| O23.32 | Infections of other parts of urinary tract in pregnancy, second trimester |
| O23.33 | Infections of other parts of urinary tract in pregnancy, third trimester |
| O23.4 | Unspecified infection of urinary tract in pregnancy |
| O23.40 | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
| O23.41 | Unspecified infection of urinary tract in pregnancy, first trimester |
| O23.42 | Unspecified infection of urinary tract in pregnancy, second trimester |
| O23.43 | Unspecified infection of urinary tract in pregnancy, third trimester |
| T83.5 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.51 | Infection and inflammatory reaction due to urinary catheter |
| T83.510 | Infection and inflammatory reaction due to cystostomy catheter |
| T83.510A | Infection and inflammatory reaction due to cystostomy catheter, initial encounter |
| T83.511 | Infection and inflammatory reaction due to indwelling urethral catheter |
| T83.511A | Infection and inflammatory reaction due to indwelling urethral catheter, initial encounter |
| T83.512 | Infection and inflammatory reaction due to nephrostomy catheter |
| T83.512A | Infection and inflammatory reaction due to nephrostomy catheter, initial encounter |
| T83.518 | Infection and inflammatory reaction due to other urinary catheter |
| T83.518A | Infection and inflammatory reaction due to other urinary catheter, initial encounter |
| T83.59 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.590 | Infection and inflammatory reaction due to implanted urinary neurostimulation device |
| T83.590A | Infection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter |
| T83.591 | Infection and inflammatory reaction due to implanted urinary sphincter |
| T83.591A | Infection and inflammatory reaction due to implanted urinary sphincter, initial encounter |
| T83.592 | Infection and inflammatory reaction due to indwelling ureteral stent |
| T83.592A | Infection and inflammatory reaction due to indwelling ureteral stent, initial encounter |
| T83.593 | Infection and inflammatory reaction due to other urinary stents |
| T83.593A | Infection and inflammatory reaction due to other urinary stents, initial encounter |
| T83.598 | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system |
| T83.598A | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter |
| Klebsiella complicated UTI | |
| B96.1 | Klebsiella pneumoniae [k. pneumoniae] as the cause of diseases classified elsewhere |
| N39.0 | Urinary tract infection, site not specified |
| O23.0 | Infections of kidney in pregnancy |
| O23.00 | Infections of kidney in pregnancy, unspecified trimester |
| O23.01 | Infections of kidney in pregnancy, first trimester |
| O23.02 | Infections of kidney in pregnancy, second trimester |
| O23.03 | Infections of kidney in pregnancy, third trimester |
| O23.1 | Infections of bladder in pregnancy |
| O23.10 | Infections of bladder in pregnancy, unspecified trimester |
| O23.11 | Infections of bladder in pregnancy, first trimester |
| O23.12 | Infections of bladder in pregnancy, second trimester |
| O23.13 | Infections of bladder in pregnancy, third trimester |
| O23.2 | Infections of urethra in pregnancy |
| O23.20 | Infections of urethra in pregnancy, unspecified trimester |
| O23.21 | Infections of urethra in pregnancy, first trimester |
| O23.22 | Infections of urethra in pregnancy, second trimester |
| O23.23 | Infections of urethra in pregnancy, third trimester |
| O23.3 | Infections of other parts of urinary tract in pregnancy |
| O23.30 | Infections of other parts of urinary tract in pregnancy, unspecified trimester |
| O23.31 | Infections of other parts of urinary tract in pregnancy, first trimester |
| O23.32 | Infections of other parts of urinary tract in pregnancy, second trimester |
| O23.33 | Infections of other parts of urinary tract in pregnancy, third trimester |
| O23.4 | Unspecified infection of urinary tract in pregnancy |
| O23.40 | Unspecified infection of urinary tract in pregnancy, unspecified trimester |
| O23.41 | Unspecified infection of urinary tract in pregnancy, first trimester |
| O23.42 | Unspecified infection of urinary tract in pregnancy, second trimester |
| O23.43 | Unspecified infection of urinary tract in pregnancy, third trimester |
| T83.5 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.51 | Infection and inflammatory reaction due to urinary catheter |
| T83.510 | Infection and inflammatory reaction due to cystostomy catheter |
| T83.510A | Infection and inflammatory reaction due to cystostomy catheter, initial encounter |
| T83.511 | Infection and inflammatory reaction due to indwelling urethral catheter |
| T83.511A | Infection and inflammatory reaction due to indwelling urethral catheter, initial encounter |
| T83.512 | Infection and inflammatory reaction due to nephrostomy catheter |
| T83.512A | Infection and inflammatory reaction due to nephrostomy catheter, initial encounter |
| T83.518 | Infection and inflammatory reaction due to other urinary catheter |
| T83.518A | Infection and inflammatory reaction due to other urinary catheter, initial encounter |
| T83.59 | Infection and inflammatory reaction due to prosthetic device, implant and graft in urinary system |
| T83.590 | Infection and inflammatory reaction due to implanted urinary neurostimulation device |
| T83.590A | Infection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter |
| T83.591 | Infection and inflammatory reaction due to implanted urinary sphincter |
| T83.591A | Infection and inflammatory reaction due to implanted urinary sphincter, initial encounter |
| T83.592 | Infection and inflammatory reaction due to indwelling ureteral stent |
| T83.592A | Infection and inflammatory reaction due to indwelling ureteral stent, initial encounter |
| T83.593 | Infection and inflammatory reaction due to other urinary stents |
| T83.593A | Infection and inflammatory reaction due to other urinary stents, initial encounter |
| T83.598 | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system |
| T83.598A | Infection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter |
Formulary Reference Tool