Michigan Medicine | University of Michigan
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ADDIN EN.CITE.DATA 1-4Polymyxin B is a cyclic polypeptide antimicrobial active against many types of clinically relevant gram-negative bacteria, including multi-drug resistant isolates. Polymyxin B is structurally related to colistin (polymyxin E) but differs in that it is commercially available as active drug while colistin is commercially available as its prodrug, colistimethate sodium. Polymyxin B has five primary amine groups which are protonated and positively charged at physiologic pH and facilitate binding to the negatively charged lipopolysaccharide (LPS) of component of the gram-negative bacterial cell wall. Once bound to LPS, polymyxin B exerts bactericidal antibiotic activity by displacing stabilizing cations and increasing cell wall permeability, ultimately leading to lysis of the bacterial cell. Indications for Use ADDIN EN.CITE <EndNote><Cite><RecNum>5846</RecNum><DisplayText><style face="superscript">1</style></DisplayText><record><rec-number>5846</rec-number><foreign-keys><key app="EN" db-id="9zs5ep0age50piexdt1xs2dmz5r2r2etxsd0" timestamp="1512161919">5846</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>Polymyxin B Sulfate [package insert]. Bedford Laboratories, Bedford, OH; June 2011.</title></titles><dates></dates><urls></urls></record></Cite></EndNote>1Polymyxin B is FDA-approved for the treatment of acute infections caused by susceptible strains of Pseudomonas aeruginosa and for serious infections with susceptible strains of Haemophilus influenzae (specifically meningitis), Escherichia coli (specifically urinary tract infections), Aerobacter [Enterobacter] aerogenes (specifically bacteremia), and Klebsiella pneumoniae (specifically bacteremia).Microbiology ADDIN EN.CITE <EndNote><Cite><RecNum>5847</RecNum><DisplayText><style face="superscript">1,5</style></DisplayText><record><rec-number>5847</rec-number><foreign-keys><key app="EN" db-id="9zs5ep0age50piexdt1xs2dmz5r2r2etxsd0" timestamp="1512162895">5847</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>CLSI. Performance standards for antimicrobial susceptibility testing; twenty-fourth informational supplement M100-S24. Wayne, PA: Clinical and Laboratory Standards Institute; 2012.</title></titles><dates></dates><urls></urls></record></Cite><Cite><RecNum>5846</RecNum><record><rec-number>5846</rec-number><foreign-keys><key app="EN" db-id="9zs5ep0age50piexdt1xs2dmz5r2r2etxsd0" timestamp="1512161919">5846</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>Polymyxin B Sulfate [package insert]. Bedford Laboratories, Bedford, OH; June 2011.</title></titles><dates></dates><urls></urls></record></Cite></EndNote>1,5Polymyxin B displays activity against many clinically important gram-negative bacteria including Pseudomonas aeruginosa, and Acinetobacter baumannii, Escherichia coli, Klebsiella spp, Citrobacter spp, and Enterobacter spp. However, the polymyxins are not universally active against Enterobacteriaceae and non-fermenting gram-negative rods. Important gram-negative species with intrinsic resistance to the polymyxins (polymyxin B and colistin) are listed in Table 1. Polymyxin B does not have activity against gram-positive bacteria or fungi. Table 1: Important Gram-negative bacteria with intrinsic resistance to polymyxinsEnterobacteriaceaeNon-EnterobacteriaceaeMorganella morganiiBurkholderia cepaciaProteus sppProvidencia sppSerratia marcesensPharmacokineticsPEVuZE5vdGU+PENpdGU+PFJlY051bT41ODQ2PC9SZWNOdW0+PERpc3BsYXlUZXh0PjxzdHlsZSBm
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ADDIN EN.CITE.DATA 1,2,6-15Polymyxin B offers pharmacokinetic advantages over colistin due to its administration directly as active drug. Colistimethate, the prodrug form of colistin, is eliminated primarily by glomerular filtration with a variable proportion of the administered dose converted to active drug via hydrolysis of five pro-drug functional groups. Both formed colistin and polymyxin B undergo extensive reabsorption (~95%) in the renal tubules and are then eliminated by non-renal mechanisms. The differential elimination of colistimethate and formed colistin along with the variable hydrolysis of the prodrug to active drug are the cause of significant interpatient variability in colistin pharmacokinetics.Table 2: Polymyxin population pharmacokinetic parameters in critically ill patientsPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYXRpb248L0F1dGhvcj48WWVhcj4yMDE2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 6,8,12ColistinPolymyxin B sulfateAbsorption ----Half-life11 h12 hVolume of DistributionCMS: 29 LColistin: 28 L29 LProtein Binding~65%~60%Metabolism CMS: Non-hepatic hydrolysis to active colistinColistin: Unknown, non-hepaticUnknown, non-hepaticEliminationCMS: RenalColistin: Non-renalNon-renalAbbreviations: CMS, colistimethate sodium; h, hours; L, litersPharmacokinetic values for colistin reflect formed colistin, unless otherwise noted. PharmacodynamicsPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EdWRoYW5pPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48
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ADDIN EN.CITE.DATA 16-23The pharmacodynamic index most predictive of bacterial killing in animal models is the ratio between the area under the free drug concentration time curve and the bacterial minimum inhibitory concentration (fAUC/MIC). The magnitude of this parameter associated with varying degrees of bacterial kill in neutropenic mouse infection models are presented below in Table 3. While colistin was used in this study, it is assumed that the pharmacodynamics can be extrapolated to polymyxin B. It is important to note that animals in this study were treated with colistin monotherapy, and therefore the pharmacodynamic targets elucidated reflect those required with monotherapy. Based on the results of in vitro combination time kill studies, it is likely that these targets would be lowered with the use of synergistic combination therapy as is done in clinical practice. Additionally, it should be emphasized that the inhibition of growth and bacterial killing only occurred for one of the three A. baumannii isolates in the lung infection model further highlighting the need for combination therapy. Many clinically important gram-negative bacteria express significant heteroresistance to polymyxin B and colistin within populations leading resistance amplification with monotherapy. Loading doses should be used to rapidly attain therapeutic concentrations, especially with colistin given the time-dependence of conversion from colistimethate for activity.The pharmacodynamic target extrapolated from these data and use for modeling of doses is the average steady state concentration during the dosing interval (Cave,ss). Using the protein bindinding of colistin and polymyxin B, the Cave,ss values corresponding to the fAUC/MIC values below can be computed. A total drug average steady-state concentration of 1-2 mcg/mL should be sufficient for bactericidal activity for infections with susceptible organisms (MIC ≤ 1) at accessible sites (i.e. thigh infection model). Conversely, total drug average steady-state concentrations of 2-4 mcg/mL would be necessary to treat infections due to pathogens with elevated polymyxin MICs (> 1) or located at difficult to penetrate sites (lung infection model). This target is generally simplified as 2-3 mcg/mL. The therapeutic index of the polymyxins is very narrow with studies finding a higher incidence of nephrotoxicity with concentrations greater than 2.5 mcg/mL. No validated therapeutic drug monitoring methods are clinically available.Table 3: Colistin fAUC/MIC [mg*h/L] values associated with varying degrees of bacterial killing in two murine infection models BacteriaStasis1 log10 kill2 log10 killThigh Infection ModelP. aeruginosa6.0 ; 7.5; 8.76.6; 10.0; 10.97.4; 13.5; 13.7A. baumanii1.4; 3.9; 9.33.5; 6.0; 13.97.4; 9.0; 17.6Lung Infection ModelP. aeruginosa15.2; 34.1; 38.643.3; 44.8; 57.951.8; NR; 105.0A. baumaniiNR, 11.6, NRNR, 20.8; NRNR; 36.8; NRAbbreviation: NR, value not reached, indicating that the tested strain did not reach the indicated level of kill for any value of fAUC/MIC testedValues represent the median fAUC/MIC associated with killing for each strain obtained from 10,000 run Monte Carlo simulationsAdverse ReactionsPEVuZE5vdGU+PENpdGU+PFJlY051bT41ODQ2PC9SZWNOdW0+PERpc3BsYXlUZXh0PjxzdHlsZSBm
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ADDIN EN.CITE.DATA 1-3,24-27Black Box Warning: Polymyxin B has a black box warning for neurotoxicity and nephrotoxicity. Renal function monitoring is recommended during therapy with a recommendation to reduce the dose of polymyxin B in patients with renal impairment. It is important to note that reducing the dose of polymyxin B in renal impairment IS NO LONGER RECOMMENDED due to an increased understanding of the pharmacokinetics of this drug. The warning also states that the polymyxin B neurotoxicity can result in respiratory paralysis from neuromuscular blockade, especially when administered after anesthesia and/or muscle relaxants. Safety of polymyxin B in human pregnancy has not been established.The primary toxicity of the polymyxins is nephrotoxicity. The frequency of nephrotoxicity associated with these agents varies from 20% up to 75% depending in the literature. Retrospective data have indicated a trend toward lower nephrotoxicity with polymyxin B relative to colistin. A 2017 meta-analysis of these data found a two-fold increased risk of nephrotoxicity (aHR 2.17, 95% CI 1.43-3.27) with colistin-treatment relative to polymyxin B. While there is a signal of lower nephrotoxicity with polymyxin B, it should be noted that the studies supporting this are all retrospective in nature with many limitations to the generalizability of their results. Polymyxin B and colistin are also associated with neurotoxicities, primarily mild and reversible paresthesias (especially perioral); however, more serious events, including neuromuscular blockade leading to apnea and seizures, have been reported. The incidence of these toxicities is difficult to ascertain due to sporadic reporting. Drug Interactions ADDIN EN.CITE <EndNote><Cite><Author>Ordooei Javan</Author><Year>2015</Year><RecNum>9</RecNum><DisplayText><style face="superscript">27</style></DisplayText><record><rec-number>9</rec-number><foreign-keys><key app="EN" db-id="9zs5ep0age50piexdt1xs2dmz5r2r2etxsd0" timestamp="1440263716">9</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ordooei Javan, A.</author><author>Shokouhi, S.</author><author>Sahraei, Z.</author></authors></contributors><auth-address>Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Niyayesh Cross Road, Valiasr Street, Tehran, Iran.</auth-address><titles><title>A review on colistin nephrotoxicity</title><secondary-title>Eur J Clin Pharmacol</secondary-title></titles><periodical><full-title>Eur J Clin Pharmacol</full-title></periodical><pages>801-10</pages><volume>71</volume><number>7</number><dates><year>2015</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1432-1041 (Electronic)
0031-6970 (Linking)</isbn><accession-num>26008213</accession-num><urls><related-urls><url> B is not a substrate of any important hepatic drug metabolizing enzymes or transporters and is unlikely to be associated with any drug-drug interactions via this mechanism. Polymyxin B is nephrotoxic and coadministration with other known nephrotoxins should be avoided. Polymyxin B should not be coadministered with aminoglycosides due to an additive risk for nephrotoxicity and neurotoxicity. Concurrently administered nephrotoxins associated with polymyxin B nephrotoxicity in clinical studies include non-steroidal anti-inflammatory drugs (NSAIDs), intravenous contrast, vancomycin, rifampin, calcineurin inhibitors, and loop diuretics. Co-administration with non-depolarizing neuromuscular blockers may lead to additive toxicity resulting in prolonged or enhanced neuromuscular blockade.Medication Safety and AdministrationBoth polymyxin B and colistimethate sodium are available as powder for reconstitution. Drug potency is listed in various units worldwide. The dosages listed below in Table 5 are equivalent expressions of drug potency and each represent the amount of drug activity contained in one vial. Polymyxin B has traditionally been diluted in 500 mL of D5W and administered via continuous infusion; however, recent stability data demonstrated stability for 24 hours at room temperature at concentrations up to 2 mg/mL and in various diluents including NS, D5, 0.5NS/D5, 0.25NS/D5. The authors recommend infusing concentrated solutions through central access to limit infusion reactions. Recommended diluents, diluent volumes, and rates of infusion for the polymyxins are presented in Table 6. An overview of information related to medication safety with polymyxin B is presented in Table 7.Table 5: Equivalent expressions of potencyPolymyxin BColistimethate Sodium50 mg360 mg500,000 IU (0.5 MIU)4,500,000 IU (4.5 MIU)150 mg CBAAbbreviations: mg = milligrams, IU = international units, MIU = million international Italicized text indicates units in MiChart, CBA = colistin base activityTable 6: Dilution and administration ADDIN EN.CITE <EndNote><Cite><Author>Lim</Author><Year>2016</Year><RecNum>2544</RecNum><DisplayText><style face="superscript">28</style></DisplayText><record><rec-number>2544</rec-number><foreign-keys><key app="EN" db-id="9zs5ep0age50piexdt1xs2dmz5r2r2etxsd0" timestamp="1484755083">2544</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lim, T. P.</author><author>Hee, D. K.</author><author>Lee, W.</author><author>Teo, J. Q.</author><author>Cai, Y.</author><author>Chia, S. Y.</author><author>Leaw, J. Y.</author><author>Lee, S. J.</author><author>Lee, L. S.</author><author>Kwa, A. L.</author></authors></contributors><titles><title>Physicochemical Stability Study of Polymyxin B in Various Infusion Solutions for Administration to Critically Ill Patients</title><secondary-title>Ann Pharmacother</secondary-title></titles><periodical><full-title>Ann Pharmacother</full-title><abbr-1>The Annals of pharmacotherapy</abbr-1></periodical><pages>790-2</pages><volume>50</volume><number>9</number><dates><year>2016</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>1542-6270 (Electronic)
1060-0280 (Linking)</isbn><accession-num>27199496</accession-num><urls><related-urls><url> BColistimethate SodiumFluidNS, D5WNS, D5WVolume250 mLa100 mLRate1-2 hours1-2 hoursTable 7: Medication safety ADDIN EN.CITE <EndNote><Cite><RecNum>5846</RecNum><DisplayText><style face="superscript">1</style></DisplayText><record><rec-number>5846</rec-number><foreign-keys><key app="EN" db-id="9zs5ep0age50piexdt1xs2dmz5r2r2etxsd0" timestamp="1512161919">5846</key></foreign-keys><ref-type name="Web Page">12</ref-type><contributors></contributors><titles><title>Polymyxin B Sulfate [package insert]. Bedford Laboratories, Bedford, OH; June 2011.</title></titles><dates></dates><urls></urls></record></Cite></EndNote>1REMS (Risk Evaluation Mitigation Strategy) NonePregnancy CategoryNoneBlack Box WarningNephrotoxicity and Neurotoxicity. See section: Adverse ReactionsISMP Medication Safety ConcernsNo ISMP documented concerns with polymyxin B. Dosing errors have been reported for intravenous colistin due to multiple potential units of potency (see Table 5). Additionally, an FDA Alert exists for nebulized colistimethate due to the potential formation of a breakdown product toxic to lung tissue if stored in an aqueous form for more than 24 hours.Hazardous Risk AssessmentNot hazardousExtravasation PotentialLowLatexNoDo Not CrushParenteral onlyElectronic Health Record Safety AssessmentNoneMiscellaneous Safety ConcernsNo bolus injections ContraindicationsHistory of hypersensitivity reactions to polymyxinsInfections due to with intrinsic resistance to polymyxinsDosage and AdministrationbmZlY3Rpb3VzIERpc2Vhc2VzLCBSYWJpbiBNZWRpY2FsIENlbnRlciwgQmVpbGluc29uIEhvc3Bp
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ADDIN EN.CITE.DATA 6-15,29-35 Intravenous and Inhaled TherapyThe optimal dosing of polymyxin B and colistin is an area of significant clinical equipoise currently. The dosing recommendations listed here are derived from pharmacokinetic and clinical outcomes studies as well as simulations assessing attainment of the pharmacodynamic efficacy targets listed above. The FDA-labeled dosing for colistin is by body weight and renal function whereas the European Medicines Agency (EMA) uses fixed doses adjusted for renal function based on newer pharmacokinetic/pharmacodynamic data. Table 8: Dosing of Systemic and Inhaled Polymyxin Agents in Adult PatientsPolymyxin AgentLoading DoseCrCl > 50 mL/minCrCl 50-30 mL/minCrCl 29-10 mL/minCrCl <10 mL/min, HDCRRTINTRAVENOUS THERAPYPolymyxin Ba,b,c2 mg/kg x1(MAX 200 mg)1.25 mg/kg q12h (MAX 200 mg/day)Colistinb,c,d5 mg/kg x1(MAX 300 mg CBA)2.5 mg CBA/kg q12h1.75 mg CBA/kg q12h2.5 mg CBA/kg q24h1.5 mg CBA/kg q24h2.5 mg CBA/kg q12hINHALED THERAPYColistin150 mg CBA nebulized q12hAbbreviations: CrCL, creatinine clearance; HD, hemodialysis; CRRT, continuous renal replacement therapy; CBA, colistin base activity; adjBW, adjusted body weight; TBW, total body weight; IBW, ideal body weighta No dosing adjustment is necessary for polymyxin B for renal or hepatic dysfunctionb adjBW should be used to calculate doses for patients with TBW > 125% IBW c Maintenance dosing should be initiated 12 hours after the loading doses are administeredd The maximum total daily maintenance dose of colistin should not exceed 300 mg CBA/daySpecial PopulationsRenal Impairment: No dosage adjustment is required for polymyxin B. See Table 8 for renal adjustments for colistinHepatic Impairment: No dosage adjustment necessary for either polymyxin B or colistinElderly: No dosage adjustment necessary; however, caution should be used as this patient population may be more sensitive to the toxicities of the polymyxins. Pediatrics: Limited data exist for the use of either systemic polymyxin B or colistin in pediatric patient populations. Recommended doses of both agents are listed in table 9 belowTable 9: Dosing of Systemic and Inhaled Poylymxin Agents in Pediatric PatientsPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaWRkaXF1aTwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+
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ADDIN EN.CITE.DATA 36-40Polymyxin AgentInfantsChildren/AdolescentsINTRAVENOUS THERAPYPolymyxin Ba,b2.5 mg/kg/day in 2 divided doses2.5 mg/kg/day in 2-4 divided doses(MAX 200 mg/day)Colistinb,c,d5 mg/kg/day in 2-4 divided doses5 mg/kg/day in 2-3 divided doses(MAX 300 mg CBA/day)INHALED THERAPYColistinNot recommended75-150 mg CBA nebulized q12hAbbreviations: CBA, colistin base activitya No dosing adjustment is necessary for polymyxin B for renal or hepatic dysfunctionb Loading doses are not routinely used in pediatric patientsd Higher doses up to 8 mg CBA/kg/day have been used in pediatric children/adolescents with cystic fibrosis. Dosing should be determined in consultation with infectious diseases or pulmonary specialists Pharmacoeconomic ConsiderationsThe economic impact of polymyxin B to Michigan Medicine is outlined in Table 10.Table 10: Availability and Cost UMHS Cost/Dosage FormUsual DoseUMHS Loading Dose Cost (70 kg)UMHS Maintenance Dose Cost per day (70 kg)Polymyxin B sulfate injection (50 mg vial)$5.812 mg/kg x 1 then 1.25 mg/kg Q12h$16.27$20.34Colistimethate sodium injection (150 mg CBA vial)$10.585 mg/kg x 1 then 2.5 mg/kg Q12h$24.69$24.69 RecommendationsBased on the above presented data, we recommend the addition of polymyxin B to the Michigan Medicine formulary as a Tier 1 restricted antimicrobial agent, requiring Antimicrobial Stewardship Team approval prior to initiation. We recommend that polymyxin B replace colistin on formulary as the preferred polymyxin B for most systemic infections as outlined in detail below. Colistin will remain on formulary for use in urinary source infections, systemic treatment of pediatric patients with cystic fibrosis, and inhaled therapy. Additionally, infectious diseases consultation is preferred when considering the use of polymyxins. The rationale for this change is as follows: AGENT SELECTION: Polymyxin B is the preferred systemic polymyxin for extraurinary infectionsRationale: Colistimethate sodium is associated with significant interpatient variability in pharmacokinetic studies.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYXRpb248L0F1dGhvcj48WWVhcj4yMDE2PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 25 Colistimethate use is restricted to urinary source infections, pediatric patients with cystic fibrosis, and inhaled therapyRationale (urinary source): Polymyxin B undergoes extensive renal tubular reabsorption and is eliminated primarily by poorly characterized non-renal mechanisms leading to negligible penetration of drug to the bladder and lower renal structures.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYW5kcmk8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA 6 Colistin undergoes extensive renal reabsorption in a manner analogous to polymyxin B; however, the prodrug colistimethate is eliminated renally and then hydrolyzed to active colistin within the lower urinary tract.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HYXJvbnppazwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+
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ADDIN EN.CITE.DATA 36,37 Although this patient population may be at increased risk for augmented renal clearance of the inactive colistimethate prodrug with resulting subtherapeutic colistin exposure, there are no pharmacokinetic data in pediatric patient populations with polymyxin B to guide dosing decisions. Additionally, patients with cystic fibrosis may also anecdotally be more sensitive to the neurotoxicities of polymyxin B than other patient populations. Selection of the optimal agent should balance the risk of colistin underexposure with the ability of the patient to tolerate systemic polymyxin B therapy and should be made in consultation with a pulmonologist and/or infectious diseases provider. Recommended criteria and exclusions for use are as follows: CRITERIA FOR USE: Systemic Therapy with Polymyxin B or ColistinTreatment of infections due to Pseudomonas aeruginosa, Acinetobacter baumannii, Enterobacter spp, Escherichia coli, Klebsiella spp, or Citrobacter spp resistant or intolerant to all beta-lactams, aminoglycosides, and fluoroquinolones. Cystic fibrosis patients with minimal clinical response to standard therapy or cultures demonstrating multi-drug resistant gram-negative isolates, as defined above. Treatment with systemic polymyxins (IV polymyxin B or IV colistin) must be in combination with one or more additional antibiotics with gram-negative activity for synergistic activity and to prevent treatment emergent resistance.PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SaWdhdHRvPC9BdXRob3I+PFllYXI+MjAxNTwvWWVhcj48
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ADDIN EN.CITE.DATA 40Isolated pathogen is susceptible ONLY to polymyxins or aminoglycosidesInhaled therapy is used in addition to systemic therapy with a polymyxin or aminoglycoside in combination with another gram-negative antibiotic (usually a beta-lactam)EXCLUSIONS FOR USE:Systemic Therapy with Polymyxin B or ColistinThe isolated pathogen is intrinsically resistant to polymyxin antibiotics (see list below).3Burkholderia cepaciaMorganella morganiiProteus sppProvidencia sppSerratia marcesensThe isolated pathogen remains susceptible to one or more aminoglycoside antibiotics. Rationale: Polymyxins are reserved as last line agents for combination salvage therapy and should not be used when alternatives are available. Aminoglycosides are effective in combination with beta-lactams against multi-drug resistant gram-negative infections and are associated with lower rates of nephrotoxicity than polymyxins (9-27% v 20-75%, respectively).PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYXJ6YTwvQXV0aG9yPjxZZWFyPjE5OTY8L1llYXI+PFJl
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